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Sample records for cuff disease randomised

  1. Rotator Cuff Disease and Injury--Evaluation and Management.

    ERIC Educational Resources Information Center

    Williams, Randy

    This presentation considers the incidence, evaluation, and management of rotator cuff disease and injury. Pathogenesis, symptoms, physical findings, treatment (therapeutic and surgical), and prevention are discussed. It is noted that rotator cuff problems, common in athletes, are usually related to an error in training or lack of training. They…

  2. Improved apparatus for predictive diagnosis of rotator cuff disease

    NASA Astrophysics Data System (ADS)

    Pillai, Anup; Hall, Brittany N.; Thigpen, Charles A.; Kwartowitz, David M.

    2014-03-01

    Rotator cuff disease impacts over 50% of the population over 60, with reports of incidence being as high as 90% within this population, causing pain and possible loss of function. The rotator cuff is composed of muscles and tendons that work in tandem to support the shoulder. Heavy use of these muscles can lead to rotator cuff tear, with the most common causes is age-related degeneration or sport injuries, both being a function of overuse. Tears ranges in severity from partial thickness tear to total rupture. Diagnostic techniques are based on physical assessment, detailed patient history, and medical imaging; primarily X-ray, MRI and ultrasonography are the chosen modalities for assessment. The final treatment technique and imaging modality; however, is chosen by the clinician is at their discretion. Ultrasound has been shown to have good accuracy for identification and measurement of full-thickness and partial-thickness rotator cuff tears. In this study, we report on the progress and improvement of our method of transduction and analysis of in situ measurement of rotator cuff biomechanics. We have improved the ability of the clinician to apply a uniform force to the underlying musculotendentious tissues while simultaneously obtaining the ultrasound image. This measurement protocol combined with region of interest (ROI) based image processing will help in developing a predictive diagnostic model for treatment of rotator cuff disease and help the clinicians choose the best treatment technique.

  3. Natural History of Rotator Cuff Disease and Implications on Management

    PubMed Central

    Hsu, Jason

    2015-01-01

    Degenerative rotator cuff disease is commonly associated with ageing and is often asymptomatic. The factors related to tear progression and pain development are just now being defined through longitudinal natural history studies. The majority of studies that follow conservatively treated painful cuff tears or asymptomatic tears that are monitored at regular intervals show slow progression of tear enlargement and muscle degeneration over time. These studies have highlighted greater risks for disease progression for certain variables, such as the presence of a full-thickness tear and involvement of the anterior aspect supraspinatus tendon. Coupling the knowledge of the natural history of degenerative cuff tear progression with variables associated with greater likelihood of successful tendon healing following surgery will allow better refinement of surgical indications for rotator cuff disease. In addition, natural history studies may better define the risks of nonoperative treatment over time. This article will review pertinent literature regarding degenerative rotator cuff disease with emphasis on variables important to defining appropriate initial treatments and refining surgical indications. PMID:26726288

  4. Impingement is not impingement: the case for calling it "Rotator Cuff Disease".

    PubMed

    McFarland, Edward G; Maffulli, Nicola; Del Buono, Angelo; Murrell, George A C; Garzon-Muvdi, Juan; Petersen, Steve A

    2013-07-01

    Historically, many causes have been proposed for rotator cuff conditions. The most prevalent theory is that the rotator cuff tendons, especially the supraspinatus, make contact with the acromion and coracoacromial ligament, resulting in pain and eventual tearing of the tendon. However, more recent evidence suggests that this concept does not explain the changes in rotator cuff tendons with age. The role of acromioplasty and coracoacromial ligament release in the treatment of rotator cuff disease has become questioned. Evidence now suggests that tendinopathy associated with aging may be a predominant factor in the development of rotator cuff degeneration. We propose that the overwhelming evidence favors factors other than "impingement" as the major cause of rotator cuff disease and that a paradigm shift in the way the development of rotator cuff pathology is conceptualized allows for a more comprehensive approach to the care of the patient with rotator cuff disease. PMID:24367779

  5. Dynamic Three-Dimensional Shoulder Mri during Active Motion for Investigation of Rotator Cuff Diseases

    PubMed Central

    Tempelaere, Christine; Pierrart, Jérome; Lefèvre-Colau, Marie-Martine; Vuillemin, Valérie; Cuénod, Charles-André; Hansen, Ulrich; Mir, Olivier; Skalli, Wafa; Gregory, Thomas

    2016-01-01

    Background MRI is the standard methodology in diagnosis of rotator cuff diseases. However, many patients continue to have pain despite treatment, and MRI of a static unloaded shoulder seems insufficient for best diagnosis and treatment. This study evaluated if Dynamic MRI provides novel kinematic data that can be used to improve the understanding, diagnosis and best treatment of rotator cuff diseases. Methods Dynamic MRI provided real-time 3D image series and was used to measure changes in the width of subacromial space, superior-inferior translation and anterior-posterior translation of the humeral head relative to the glenoid during active abduction. These measures were investigated for consistency with the rotator cuff diseases classifications from standard MRI. Results The study included: 4 shoulders with massive rotator cuff tears, 5 shoulders with an isolated full-thickness supraspinatus tear, 5 shoulders with tendinopathy and 6 normal shoulders. A change in the width of subacromial space greater than 4mm differentiated between rotator cuff diseases with tendon tears (massive cuff tears and supraspinatus tear) and without tears (tendinopathy) (p = 0.012). The range of the superior-inferior translation was higher in the massive cuff tears group (6.4mm) than in normals (3.4mm) (p = 0.02). The range of the anterior-posterior translation was higher in the massive cuff tears (9.2 mm) and supraspinatus tear (9.3 mm) shoulders compared to normals (3.5mm) and tendinopathy (4.8mm) shoulders (p = 0.05). Conclusion The Dynamic MRI enabled a novel measure; ‘Looseness’, i.e. the translation of the humeral head on the glenoid during an abduction cycle. Looseness was better able at differentiating different forms of rotator cuff disease than a simple static measure of relative glenohumeral position. PMID:27434235

  6. The clinical utility of ultrasonography for rotator cuff disease, shoulder impingement syndrome and subacromial bursitis.

    PubMed

    Awerbuch, Mark S

    2008-01-01

    Periarticular shoulder disorders are common in clinical practice, and diagnosis is often difficult. Medicare statistics indicate that between 2001 and 2006 the use of diagnostic shoulder ultrasonography increased significantly. Rotator cuff disease, shoulder impingement syndrome and subacromial bursitis are among the most common diagnoses reported on shoulder ultrasonography. Shoulder ultrasonography is useful in the diagnosis of full thickness tears, but its utility for other rotator cuff disorders, shoulder impingement syndrome and subacromial bursitis is less well established. PMID:18205566

  7. Imaging Algorithms for Evaluating Suspected Rotator Cuff Disease: Society of Radiologists in Ultrasound Consensus Conference Statement

    PubMed Central

    Jacobson, Jon A.; Benson, Carol B.; Bancroft, Laura W.; Bedi, Asheesh; McShane, John M.; Miller, Theodore T.; Parker, Laurence; Smith, Jay; Steinbach, Lynne S.; Teefey, Sharlene A.; Thiele, Ralf G.; Tuite, Michael J.; Wise, James N.; Yamaguchi, Ken

    2013-01-01

    The Society of Radiologists in Ultrasound convened a panel of specialists from a variety of medical disciplines to reach a consensus about the recommended imaging evaluation of painful shoulders with clinically suspected rotator cuff disease. The panel met in Chicago, Ill, on October 18 and 19, 2011, and created this consensus statement regarding the roles of radiography, ultrasonography (US), computed tomography (CT), CT arthrography, magnetic resonance (MR) imaging, and MR arthrography. The consensus panel consisted of two co-moderators, a facilitator, a statistician and health care economist, and 10 physicians who have specialty expertise in shoulder pain evaluation and/or treatment. Of the 13 physicians on the panel, nine were radiologists who were chosen to represent a broad range of skill sets in diagnostic imaging, different practice types (private and academic), and different geographical regions of the United States. Five of the radiologists routinely performed musculoskeletal US as part of their practice and four did not. There was also one representative from each of the following clinical specialties: rheumatology, physical medicine and rehabilitation, orthopedic surgery, and nonoperative sports medicine. The goal of this conference was to construct several algorithms with which to guide the imaging evaluation of suspected rotator cuff disease in patients with a native rotator cuff, patients with a repaired rotator cuff, and patients who have undergone shoulder replacement. The panel hopes that these recommendations will lead to greater uniformity in rotator cuff imaging and more cost-effective care for patients suspected of having rotator cuff abnormality. © RSNA, 2013 PMID:23401583

  8. Towards predictive diagnosis and management of rotator cuff disease: using curvelet transform for edge detection and segmentation of tissue

    NASA Astrophysics Data System (ADS)

    Pai Raikar, Vipul; Kwartowitz, David M.

    2016-04-01

    Degradation and injury of the rotator cuff is one of the most common diseases of the shoulder among the general population. In orthopedic injuries, rotator cuff disease is only second to back pain in terms of overall reduced quality of life for patients. Clinically, this disease is managed via pain and activity assessment and diagnostic imaging using ultrasound and MRI. Ultrasound has been shown to have good accuracy for identification and measurement of rotator cuff tears. In our previous work, we have developed novel, real-time techniques to biomechanically assess the condition of the rotator cuff based on Musculoskeletal Ultrasound. Of the rotator cuff tissues, supraspinatus is the first that sees degradation and is the most commonly affected. In our work, one of the challenges lies in effectively segmenting and characterizing the supraspinatus. We are exploring the possibility of using curvelet transform for improving techniques to segment tissue in ultrasound. Curvelets have been shown to give optimal multi-scale representation of edges in images. They are designed to represent edges and singularities along curves in images which makes them an attractive proposition for use in ultrasound segmentation. In this work, we present a novel approach to the possibility of using curvelet transforms for automatic edge and feature extraction for the supraspinatus.

  9. Postoperative pharyngolaryngeal adverse events with laryngeal mask airway (LMA Supreme) in laparoscopic surgical procedures with cuff pressure limiting 25 cmH₂O: prospective, blind, and randomised study.

    PubMed

    Kang, Joo-Eun; Oh, Chung-Sik; Choi, Jae Won; Son, Il Soon; Kim, Seong-Hyop

    2014-01-01

    To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA) manufacturers recommend maximum cuff pressures not exceeding 60 cmH₂O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH₂O, L group) and high (at 60 cmH₂O, H group) LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU) (postoperative day 1, POD 1) and 24 hours after discharge from PACU (postoperative day 2, POD 2). All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP) showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients) and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2) were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH₂O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334.

  10. Shoulder impairments and their association with symptomatic rotator cuff disease in breast cancer survivors.

    PubMed

    Ebaugh, David; Spinelli, Bryan; Schmitz, Kathryn H

    2011-10-01

    Over 2.6 million breast cancer survivors currently reside in the United States. While improvements in the medical management of women diagnosed with breast cancer have resulted in a 5-year survival rate of 89%, curative treatments are associated with a high prevalence of shoulder and arm morbidity, which, in turn, can negatively impact a woman's quality of life. Breast cancer survivors frequently experience shoulder and arm pain, decreased range of motion, muscle weakness, and lymphedema. These symptoms can lead to difficulties with daily activities ranging from overhead reaching and carrying objects to caring for family and returning to work. Despite health care professionals awareness of these problems, a significant number of breast cancer survivors are confronted with long-term, restricted use of their affected shoulder and upper extremity. This problem may partially be explained by: (1) an incomplete understanding of relevant impairments and diagnoses associated with shoulder/arm pain and limited upper extremity use, and (2) the limited effectiveness of current rehabilitation interventions for managing shoulder pain and decreased upper extremity function in breast cancer survivors. Because breast cancer treatment directly involves the neuromusculoskeletal tissues of the shoulder girdle, it is understandable why breast cancer survivors are likely to develop shoulder girdle muscle weakness and fatigue, decreased shoulder motion, altered shoulder girdle alignment, and lymphedema. These impairments can be associated with diagnoses such as post-mastectomy syndrome, adhesive capsulitis, myofascial dysfunction, and brachial plexopathy, all of which have been reported among breast cancer survivors. It is our belief that these impairments also put women at risk for developing symptomatic rotator cuff disease. In this paper we set forth the rationale for our belief that breast cancer treatments and subsequent impairments of shoulder girdle neuromusculoskeletal tissues

  11. Treatment of non-traumatic rotator cuff tears: A randomised controlled trial with one-year clinical results.

    PubMed

    Kukkonen, J; Joukainen, A; Lehtinen, J; Mattila, K T; Tuominen, E K J; Kauko, T; Aärimaa, V

    2014-01-01

    We have compared three different methods of treating symptomatic non-traumatic tears of the supraspinatus tendon in patients above 55 years of age. A total of 180 shoulders (173 patients) with supraspinatus tendon tears were randomly allocated into one of three groups (each of 60 shoulders); physiotherapy (group 1), acromioplasty and physiotherapy (group 2) and rotator cuff repair, acromioplasty and physiotherapy (group 3). The Constant score was assessed and followed up by an independent observer pre-operatively and at three, six and twelve months after the intervention. Of these, 167 shoulders were available for assessment at one year (follow-up rate of 92.8%). There were 55 shoulders in group 1 (24 in males and 31 in females, mean age 65 years (55 to 79)), 57 in group 2 (29 male and 28 female, mean age 65 years (55 to 79)) and 55 shoulders in group 3 (26 male and 29 female, mean age 65 years (55 to 81)). There were no between-group differences in the Constant score at final follow-up: 74.1 (sd 14.2), 77.2 (sd 13.0) and 77.9 (sd 12.1) in groups 1, 2 and 3, respectively (p = 0.34). The mean change in the Constant score was 17.0, 17.5, and 19.8, respectively (p = 0.34). These results suggest that at one-year follow-up, operative treatment is no better than conservative treatment with regard to non-traumatic supraspinatus tears, and that conservative treatment should be considered as the primary method of treatment for this condition. PMID:24395315

  12. The Role of the Peripheral and Central Nervous Systems in Rotator Cuff Disease

    PubMed Central

    Bachasson, Damien; Singh, Anshuman; Shah, Sameer; Lane, John G.; Ward, Samuel R.

    2015-01-01

    Rotator cuff (RC) disease is an extremely common condition associated with shoulder pain, reduced functional capacities and impaired quality of life. It primarily involves alterations in tendon health and mechanical properties that can ultimately lead to tendon failure. RC tendon tears induce progressive muscular changes that negatively impact surgical reparability of the RC tendons and clinical outcomes. At the same time, a significant base of clinical data suggests a relatively weak relationship between RC integrity and clinical presentation, emphasizing the multifactorial aspects of RC disease. This review aims to summarize the potential contribution of peripheral, spinal and supraspinal neural factors that may: (i) exacerbate structural and functional muscle changes induced by tendon tear, (ii) compromise the reversal of these changes during surgery and rehabilitation, (iii) contribute to pain generation and persistence of pain, iv) impair shoulder function through reduced proprioception, kinematics and muscle recruitment, and iv) help to explain interindividual differences and response to treatment. Given the current clinical and scientific interest in peripheral nerve injury in the context of RC disease and surgery, we carefully reviewed this body of literature with a particular emphasis for suprascapular neuropathy that has generated a large number of studies in the past decade. Within this process, we highlight the gaps in current knowledge and suggest research avenues for scientists and clinicians. PMID:26189809

  13. Maintaining endotracheal tube cuff pressure at 20 mm Hg to prevent dysphagia after anterior cervical spine surgery; protocol of a double-blind randomised controlled trial

    PubMed Central

    2013-01-01

    Background In anterior cervical spine surgery a retractor is obligatory to approach the spine. Previous studies showed an increase of endotracheal tube cuff pressure after placement of a retractor. It is known that high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and sore throat. However, until now no evidence supports the fact whether adjusting the endotracheal tube cuff pressure during anterior cervical spine surgery will prevent this comorbidity. We present the design of a randomized controlled trial to determine whether adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery will prevent postoperative dysphagia. Methods/design 177 patients (aged 18–90 years) scheduled for anterior cervical spine surgery on 1 or more levels will be included. After intubation, endotracheal tube cuff pressure is manually inflated to 20 mm Hg in all patients. Patients will be randomized into two groups. In the control group endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention group endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg and air is withdrawn when cuff pressure exceeds 20 mm Hg. Endotracheal tube cuff pressure is measured after intubation, before and after placement and removal of the retractor. Again air is inflated if cuff pressure sets below 20 mmHg after removal of the retractor. The primary outcome measure is postoperative dysphagia. Other outcome measures are postoperative hoarseness, postoperative sore throat, degree of dysphagia, length of hospital stay, and pneumonia. The study is a single centre double blind randomized trial in which patients and research nurses will be kept blinded for the allocated treatment during the follow-up period of 2 months. Discussion Postoperative dysphagia occurs frequently after anterior cervical spine surgery. This may be related to high

  14. Effects of therapeutic ultrasound and exercise on pain, function, and isokinetic shoulder rotator strength of patients with rotator cuff disease

    PubMed Central

    Analan, Pınar Doruk; Leblebici, Berrin; Adam, Mehmet

    2015-01-01

    [Purpose] The aim of this prospective, double-blind, randomized, placebo-controlled study was to evaluate the effects of therapeutic continuous ultrasound (US) on patients with rotator cuff disease. [Subjects and Methods] Twenty-two patients were treated with a standard physiotherapy program consisting of a hot-pack, transcutaneous electrical nerve stimulation (TENS), exercises, and US that was supervised by the same physiotherapist. The patients were randomly assigned to either a group that received true US (n=11) or one that received sham US (n=11). [Results] There were significant differences between the pre- and post-intervention UCLA Shoulder Rating Scale and Constant-Murley Shoulder Outcome scores, VAS, and external rotation (ER) peak torque 60°/second values for both the true and sham US groups. However, the between-group differences were not statistically significant. [Conclusion] In patients with rotator cuff disease, physiotherapy interventions effectively treat the pain, improve the clinical status, and increase the muscle strength of the shoulder ER at a low constant angular velocity, with functional improvement being seen immediately after treatment. However, at the end of the intervention, the US had yielded no additional efficacy to the physiotherapy treatment regimen of the patients with rotator cuff disease. PMID:26644656

  15. Effects of therapeutic ultrasound and exercise on pain, function, and isokinetic shoulder rotator strength of patients with rotator cuff disease.

    PubMed

    Analan, Pınar Doruk; Leblebici, Berrin; Adam, Mehmet

    2015-10-01

    [Purpose] The aim of this prospective, double-blind, randomized, placebo-controlled study was to evaluate the effects of therapeutic continuous ultrasound (US) on patients with rotator cuff disease. [Subjects and Methods] Twenty-two patients were treated with a standard physiotherapy program consisting of a hot-pack, transcutaneous electrical nerve stimulation (TENS), exercises, and US that was supervised by the same physiotherapist. The patients were randomly assigned to either a group that received true US (n=11) or one that received sham US (n=11). [Results] There were significant differences between the pre- and post-intervention UCLA Shoulder Rating Scale and Constant-Murley Shoulder Outcome scores, VAS, and external rotation (ER) peak torque 60°/second values for both the true and sham US groups. However, the between-group differences were not statistically significant. [Conclusion] In patients with rotator cuff disease, physiotherapy interventions effectively treat the pain, improve the clinical status, and increase the muscle strength of the shoulder ER at a low constant angular velocity, with functional improvement being seen immediately after treatment. However, at the end of the intervention, the US had yielded no additional efficacy to the physiotherapy treatment regimen of the patients with rotator cuff disease. PMID:26644656

  16. A systematic review of the histological and molecular changes in rotator cuff disease

    PubMed Central

    Dean, B. J. F.; Franklin, S. L.; Carr, A. J.

    2012-01-01

    Introduction The pathogenesis of rotator cuff disease (RCD) is complex and not fully understood. This systematic review set out to summarise the histological and molecular changes that occur throughout the spectrum of RCD. Methods We conducted a systematic review of the scientific literature with specific inclusion and exclusion criteria. Results A total of 101 studies met the inclusion criteria: 92 studies used human subjects exclusively, seven used animal overuse models, and the remaining two studies involved both humans and an animal overuse model. A total of 58 studies analysed supraspinatus tendon exclusively, 16 analysed subacromial bursal tissue exclusively, while the other studies analysed other tissue or varying combinations of tissue types including joint fluid and muscle. The molecular biomarkers that were altered in RCD included matrix substances, growth factors, enzymes and other proteins including certain neuropeptides. Conclusions The pathogenesis of RCD is being slowly unravelled as a result of the significant recent advances in molecular medicine. Future research aimed at further unlocking these key molecular processes will be pivotal in developing new surgical interventions both in terms of the diagnosis and treatment of RCD. PMID:23610686

  17. Relation between burden of disease and randomised evidence in sub-Saharan Africa: survey of research

    PubMed Central

    Isaakidis, Petros; Swingler, George H; Pienaar, Elizabeth; Volmink, Jimmy; Ioannidis, John P A

    2002-01-01

    Objective To evaluate whether the amount of randomised clinical research on various medical conditions is related to the burden of disease and health needs of the local populations in sub-Saharan Africa. Design Construction and analysis of comprehensive database of randomised controlled trials in sub-Saharan Africa based on Medline, the Cochrane Controlled Trials Register, and several African databases. Setting Sub-Saharan Africa. Main outcome measures Number of trials and randomised subjects for each category of disease in the global burden of disease taxonomy; ratios of disability adjusted life years (DALYs) per amount of randomised evidence. Results 1179 eligible randomised controlled trials were identified. The number of trials published each year increased over time. Almost half of the trials (n=565) had been done in South Africa. There was relatively good correlation between the estimated burden of disease at year 2000 and the number of trials performed (r=0.53, P=0.024) and the number of participants randomised (r=0.68, P=0.002). However,some conditions—for example, injuries (over 20 000 DALYs per patient ever randomised)—were more neglected than others. Conclusion Despite recent improvements, few clinical trials are done in sub-Saharan Africa. Clinical research in this part of the world should focus more evenly on the major contributors to burden of disease. What is already known on this topicSub-Saharan Africa has a large burden of diseaseLittle clinical research is conducted for problems affecting sub-Saharan AfricaWhat this study addsOnly 1179 randomised controlled trials conducted in sub-Saharan Africa in the past 50 years were identifiedCorrelation between the amount of randomised evidence and the estimated burden of disease was fairly goodHowever, some disease categories were more neglected than others, with the worst being injuries PMID:11909786

  18. Effect of Angiogenesis-Related Cytokines on Rotator Cuff Disease: The Search for Sensitive Biomarkers of Early Tendon Degeneration

    PubMed Central

    Savitskaya, Yulia A.; Izaguirre, Aldo; Sierra, Luis; Perez, Francisco; Cruz, Francisco; Villalobos, Enrique; Almazan, Arturo; Ibarra, Clemente

    2011-01-01

    Background: Hallmarks of the pathogenesis of rotator cuff disease (RCD) include an abnormal immune response, angiogenesis, and altered variables of vascularity. Degenerative changes enhance production of pro-inflammatory, anti-inflammatory, and vascular angiogenesis-related cytokines (ARC) that play a pivotal role in the immune response to arthroscopic surgery and participate in the pathogenesis of RCD. The purpose of this study was to evaluate the ARC profile, ie, interleukin (IL): IL-1β, IL-6, IL-8, IL-10, vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), and angiogenin (ANG), in human peripheral blood serum and correlate this with early degenerative changes in patients with RCD. Methods: Blood specimens were obtained from 200 patients with RCD and 200 patients seen in the orthopedic clinic for nonrotator cuff disorders. Angiogenesis imaging assays was performed using power Doppler ultrasound to evaluate variables of vascularity in the rotator cuff tendons. Expression of ARC was measured by commercial Bio-Plex Precision Pro Human Cytokine Assays. Results: Baseline concentrations of IL-1β, IL-8, and VEGF was significantly higher in RCD patients than in controls. Significantly higher serum VEGF levels were found in 85% of patients with RCD, and correlated with advanced stage of disease (r = 0.75; P < 0.0005), average microvascular density (r = 0.68, P < 0.005), and visual analog score (r = 0.75, P < 0.0002) in RCD patients. ANG and IL-10 levels were significantly lower in RCD patients versus controls. IL-1β and ANG levels were significantly correlated with degenerative tendon grade in RCD patients. No difference in IL-6 and bFGF levels was observed between RCD patients and controls. Patients with degenerative changes had markedly lower ANG levels compared with controls. Power Doppler ultrasound showed high blood vessel density in patients with tendon rupture. Conclusion: The pathogenesis of RCD is associated with an imbalance

  19. Ultrasound-Guided Myofascial Trigger Point Injection Into Brachialis Muscle for Rotator Cuff Disease Patients With Upper Arm Pain: A Pilot Study

    PubMed Central

    Suh, Mi Ri; Chang, Won Hyuk; Choi, Hyo Seon

    2014-01-01

    Objective To assess the efficacy of trigger point injection into brachialis muscle for rotator cuff disease patients with upper arm pain. Methods A prospective, randomized, and single-blinded clinical pilot trial was performed at university rehabilitation hospital. Twenty-one patients clinically diagnosed with rotator cuff disease suspected of having brachialis myofascial pain syndrome (MPS) were randomly allocated into two groups. Effect of ultrasound (US)-guided trigger point injection (n=11) and oral non-steroidal anti-inflammatory drug (NSAID) (n=10) was compared by visual analog scale (VAS). Results US-guided trigger point injection of brachialis muscle resulted in excellent outcome compared to the oral NSAID group. Mean VAS scores decreased significantly after 2 weeks of treatment compared to the baseline in both groups (7.3 vs. 4.5 in the injection group and 7.4 vs. 5.9 in the oral group). The decrease of the VAS score caused by injection (ДVAS=-2.8) was significantly larger than caused by oral NSAID (ДVAS=-1.5) (p<0.05). Conclusion In patients with rotator cuff disease, US-guided trigger point injection of the brachialis muscle is safe and effective for both diagnosis and treatment when the cause of pain is suspected to be originated from the muscle. PMID:25379497

  20. Comparison of effects of ProSeal LMA™ laryngeal mask airway cuff inflation with air, oxygen, air:oxygen mixture and oxygen:nitrous oxide mixture in adults: A randomised, double-blind study

    PubMed Central

    Sharma, Mona; Sinha, Renu; Trikha, Anjan; Ramachandran, Rashmi; Chandralekha, C

    2016-01-01

    Background and Aims: Laryngeal mask airway (LMA) cuff pressure increases when the air is used for the cuff inflation during oxygen: nitrous oxide (O2:N2O) anaesthesia, which may lead to various problems. We compared the effects of different gases for ProSeal LMA™ (PLMA) cuff inflation in adult patients for various parameters. Methods: A total of 120 patients were randomly allocated to four groups, according to composition of gases used to inflate the PLMA cuff to achieve 40 cmH2 O cuff pressure, air (Group A), 50% O2 :air (Group OA), 50% O2:N2O (Group ON) and 100% O2 (Group O). Cuff pressure, cuff volume and ventilator parameters were monitored intraoperatively. Pharyngolaryngeal parameters were assessed at 1, 2 and 24 h postoperatively. Statistical analysis was performed using ANOVA, Fisher's exact test and step-wise logistic regression. Results: Cuff pressure significantly increased at 10, 15 and 30 min in Group A, OA and O from initial pressure. Cuff pressure decreased at 5 min in Group ON (36.6 ± 3.5 cmH2 O) (P = 0.42). PLMA cuff volume increased in Group A, OA, O, but decreased in Group ON (6.16 ± 2.8 ml [P < 0.001], 4.7 ± 3.8 ml [P < 0.001], 1.4 ± 3.19 ml [P = 0.023] and − 1.7 ± 4.9 ml [P = 0.064], respectively), from basal levels. Ventilatory parameters were comparable in all four groups. There was no significant association between sore throat and cuff pressure, with odds ratio 1.002. Conclusion: Cuff inflation with 50% O2:N2O mixture provided more stable cuff pressure in comparison to air, O2 :air, 100% O2 during O2:N2O anaesthesia. Ventilatory parameters did not change with variation in PLMA cuff pressure. Post-operative sore throat had no correlation with cuff pressure.

  1. Comparison of effects of ProSeal LMA™ laryngeal mask airway cuff inflation with air, oxygen, air:oxygen mixture and oxygen:nitrous oxide mixture in adults: A randomised, double-blind study

    PubMed Central

    Sharma, Mona; Sinha, Renu; Trikha, Anjan; Ramachandran, Rashmi; Chandralekha, C

    2016-01-01

    Background and Aims: Laryngeal mask airway (LMA) cuff pressure increases when the air is used for the cuff inflation during oxygen: nitrous oxide (O2:N2O) anaesthesia, which may lead to various problems. We compared the effects of different gases for ProSeal LMA™ (PLMA) cuff inflation in adult patients for various parameters. Methods: A total of 120 patients were randomly allocated to four groups, according to composition of gases used to inflate the PLMA cuff to achieve 40 cmH2 O cuff pressure, air (Group A), 50% O2 :air (Group OA), 50% O2:N2O (Group ON) and 100% O2 (Group O). Cuff pressure, cuff volume and ventilator parameters were monitored intraoperatively. Pharyngolaryngeal parameters were assessed at 1, 2 and 24 h postoperatively. Statistical analysis was performed using ANOVA, Fisher's exact test and step-wise logistic regression. Results: Cuff pressure significantly increased at 10, 15 and 30 min in Group A, OA and O from initial pressure. Cuff pressure decreased at 5 min in Group ON (36.6 ± 3.5 cmH2 O) (P = 0.42). PLMA cuff volume increased in Group A, OA, O, but decreased in Group ON (6.16 ± 2.8 ml [P < 0.001], 4.7 ± 3.8 ml [P < 0.001], 1.4 ± 3.19 ml [P = 0.023] and − 1.7 ± 4.9 ml [P = 0.064], respectively), from basal levels. Ventilatory parameters were comparable in all four groups. There was no significant association between sore throat and cuff pressure, with odds ratio 1.002. Conclusion: Cuff inflation with 50% O2:N2O mixture provided more stable cuff pressure in comparison to air, O2 :air, 100% O2 during O2:N2O anaesthesia. Ventilatory parameters did not change with variation in PLMA cuff pressure. Post-operative sore throat had no correlation with cuff pressure. PMID:27601739

  2. Rotator cuff problems

    MedlinePlus

    ... rotator cuff is a group of muscles and tendons that attach to the bones of the shoulder ... Rotator cuff tendinitis refers to irritation of these tendons and inflammation of the bursa (a normally smooth ...

  3. Partial Thickness Rotator Cuff Tears: Current Concepts

    PubMed Central

    Matthewson, Graeme; Beach, Cara J.; Nelson, Atiba A.; Woodmass, Jarret M.; Ono, Yohei; Boorman, Richard S.; Lo, Ian K. Y.; Thornton, Gail M.

    2015-01-01

    Partial thickness rotator cuff tears are a common cause of pain in the adult shoulder. Despite their high prevalence, the diagnosis and treatment of partial thickness rotator cuff tears remains controversial. While recent studies have helped to elucidate the anatomy and natural history of disease progression, the optimal treatment, both nonoperative and operative, is unclear. Although the advent of arthroscopy has improved the accuracy of the diagnosis of partial thickness rotator cuff tears, the number of surgical techniques used to repair these tears has also increased. While multiple repair techniques have been described, there is currently no significant clinical evidence supporting more complex surgical techniques over standard rotator cuff repair. Further research is required to determine the clinical indications for surgical and nonsurgical management, when formal rotator cuff repair is specifically indicated and when biologic adjunctive therapy may be utilized. PMID:26171251

  4. Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis

    PubMed Central

    White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

    2016-01-01

    Summary Background Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. Methods We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. Findings In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04–1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08–1·29), 1·10 (1·00–1·22), and 1·05 (0·92–1·20), respectively, per 1 SD increment in plasma urate. Interpretation Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for

  5. Composition of Muscle Fiber Types in Rat Rotator Cuff Muscles.

    PubMed

    Rui, Yongjun; Pan, Feng; Mi, Jingyi

    2016-10-01

    The rat is a suitable model to study human rotator cuff pathology owing to the similarities in morphological anatomy structure. However, few studies have reported the composition muscle fiber types of rotator cuff muscles in the rat. In this study, the myosin heavy chain (MyHC) isoforms were stained by immunofluorescence to show the muscle fiber types composition and distribution in rotator cuff muscles of the rat. It was found that rotator cuff muscles in the rat were of mixed fiber type composition. The majority of rotator cuff fibers labeled positively for MyHCII. Moreover, the rat rotator cuff muscles contained hybrid fibers. So, compared with human rotator cuff muscles composed partly of slow-twitch fibers, the majority of fast-twitch fibers in rat rotator cuff muscles should be considered when the rat model study focus on the pathological process of rotator cuff muscles after injury. Gaining greater insight into muscle fiber types in rotator cuff muscles of the rat may contribute to elucidate the mechanism of pathological change in rotator cuff muscles-related diseases. Anat Rec, 299:1397-1401, 2016. © 2016 Wiley Periodicals, Inc.

  6. Association between randomised trial evidence and global burden of disease: cross sectional study (Epidemiological Study of Randomized Trials—ESORT)

    PubMed Central

    Odutayo, Ayodele; Hsiao, Allan J; Shakir, Mubeen; Hopewell, Sally; Rahimi, Kazem; Altman, Douglas G

    2015-01-01

    Objectives To determine whether an association exists between the number of published randomised controlled trials and the global burden of disease, whether certain diseases are under-investigated relative to their burden, and whether the relation between the output of randomised trials and global burden of disease can be explained by the relative disease burden in high and low income regions. Design Cross sectional investigation. Study sample All primary reports of randomised trials published in December 2012 and indexed in PubMed by 17 November 2013. Main outcome measures Number of trials conducted and number of participants randomised for each of 239 different diseases or injuries; variation in each outcome explainable by total disability adjusted life years (a measure of the overall burden of each disease) and the ratio of disability adjusted life years in low income to high income regions (a measure of whether a disease is more likely to affect people living in high income regions) quantified using multivariable regression. Results 4190 abstracts were reviewed and 1351 primary randomised trials identified, of which 1097 could be classified using the global burden of disease taxonomy. Total disability adjusted life years was poorly associated with number of randomised trials and number of participants randomised in univariable analysis (Spearman’s r=0.35 and 0.33, respectively), although it was a significant predictor in the univariable and multivariable models (P<0.001). Diseases for which the burden was predominantly located in low income regions had sevenfold fewer trials per million disability adjusted life years than diseases predominantly located in high income regions. However, only 26% of the variation in number of trials among diseases could be explained by total disability adjusted life years and the ratio of disability adjusted life years in low income regions to high income regions. Many high income type diseases (for example, neck pain

  7. Serious rotator cuff injuries.

    PubMed

    Jobe, F W

    1983-07-01

    Usually, serious rotator cuff injuries can be operated upon and a high level of performance can be achieved afer surgery. This is not so for the substantial tears seen in baseball pitchers. However, a damaged rotator cuff can be rehabilitated and can recover from the threatened tear without surgery if detected early enough and given the proper treatment.

  8. Impingement is not impingement: the case for calling it “Rotator Cuff Disease”

    PubMed Central

    McFarland, Edward G.; Maffulli, Nicola; Del Buono, Angelo; Murrell, George A. C.; Garzon-Muvdi, Juan; Petersen, Steve A.

    2013-01-01

    Summary Historically, many causes have been proposed for rotator cuff conditions. The most prevalent theory is that the rotator cuff tendons, especially the supraspinatus, make contact with the acromion and coracoacromial ligament, resulting in pain and eventual tearing of the tendon. However, more recent evidence suggests that this concept does not explain the changes in rotator cuff tendons with age. The role of acromioplasty and coracoacromial ligament release in the treatment of rotator cuff disease has become questioned. Evidence now suggests that tendinopathy associated with aging may be a predominant factor in the development of rotator cuff degeneration. We propose that the overwhelming evidence favors factors other than “impingement” as the major cause of rotator cuff disease and that a paradigm shift in the way the development of rotator cuff pathology is conceptualized allows for a more comprehensive approach to the care of the patient with rotator cuff disease. PMID:24367779

  9. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

    PubMed Central

    2014-01-01

    Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

  10. Rotator cuff repair

    MedlinePlus

    ... torn rotator cuff is usually successful in relieving pain in the shoulder. The procedure may not always return strength to ... may not fully heal. Stiffness, weakness, and chronic pain may still be ... are not followed. Older patients (over age 65). Smoking.

  11. Rotator Cuff Injuries.

    ERIC Educational Resources Information Center

    Connors, G. Patrick

    Many baseball players suffer from shoulder injuries related to the rotator cuff muscles. These injuries may be classified as muscular strain, tendonitis or tenosynovitis, and impingement syndrome. Treatment varies from simple rest to surgery, so it is important to be seen by a physician as soon as possible. In order to prevent these injuries, the…

  12. Mendelian Randomisation study of the influence of eGFR on coronary heart disease.

    PubMed

    Charoen, Pimphen; Nitsch, Dorothea; Engmann, Jorgen; Shah, Tina; White, Jonathan; Zabaneh, Delilah; Jefferis, Barbara; Wannamethee, Goya; Whincup, Peter; Mulick Cassidy, Amy; Gaunt, Tom; Day, Ian; McLachlan, Stela; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Brunner, Eric; Langenberg, Claudia; Ben-Shlomo, Yoav; Hingorani, Aroon; Whittaker, John; Pablo Casas, Juan; Dudbridge, Frank

    2016-01-01

    Impaired kidney function, as measured by reduced estimated glomerular filtration rate (eGFR), has been associated with increased risk of coronary heart disease (CHD) in observational studies, but it is unclear whether this association is causal or the result of confounding or reverse causation. In this study we applied Mendelian randomisation analysis using 17 genetic variants previously associated with eGFR to investigate the causal role of kidney function on CHD. We used 13,145 participants from the UCL-LSHTM-Edinburgh-Bristol (UCLEB) Consortium and 194,427 participants from the Coronary ARtery DIsease Genome-wide Replication and Meta-analysis plus Coronary Artery Disease (CARDIoGRAMplusC4D) consortium. We observed significant association of an unweighted gene score with CHD risk (odds ratio = 0.983 per additional eGFR-increasing allele, 95% CI = 0.970-0.996, p = 0.008). However, using weights calculated from UCLEB, the gene score was not associated with disease risk (p = 0.11). These conflicting results could be explained by a single SNP, rs653178, which was not associated with eGFR in the UCLEB sample, but has known pleiotropic effects that prevent us from drawing a causal conclusion. The observational association between low eGFR and increased CHD risk was not explained by potential confounders, and there was no evidence of reverse causation, therefore leaving the remaining unexplained association as an open question.

  13. Regenerative Medicine in Rotator Cuff Injuries

    PubMed Central

    Randelli, Pietro; Ragone, Vincenza; Menon, Alessandra; Cabitza, Paolo; Banfi, Giuseppe

    2014-01-01

    Rotator cuff injuries are a common source of shoulder pathology and result in an important decrease in quality of patient life. Given the frequency of these injuries, as well as the relatively poor result of surgical intervention, it is not surprising that new and innovative strategies like tissue engineering have become more appealing. Tissue-engineering strategies involve the use of cells and/or bioactive factors to promote tendon regeneration via natural processes. The ability of numerous growth factors to affect tendon healing has been extensively analyzed in vitro and in animal models, showing promising results. Platelet-rich plasma (PRP) is a whole blood fraction which contains several growth factors. Controlled clinical studies using different autologous PRP formulations have provided controversial results. However, favourable structural healing rates have been observed for surgical repair of small and medium rotator cuff tears. Cell-based approaches have also been suggested to enhance tendon healing. Bone marrow is a well known source of mesenchymal stem cells (MSCs). Recently, ex vivo human studies have isolated and cultured distinct populations of MSCs from rotator cuff tendons, long head of the biceps tendon, subacromial bursa, and glenohumeral synovia. Stem cells therapies represent a novel frontier in the management of rotator cuff disease that required further basic and clinical research. PMID:25184132

  14. Biologics in rotator cuff surgery

    PubMed Central

    Schär, Michael O; Rodeo, Scott A

    2014-01-01

    Pathologies of the rotator cuff are by far the most common cause of shoulder dysfunction and pain. Even though reconstruction of the rotator cuff results in improved clinical outcome scores, including decreased pain, several studies report high failure rates. Orthopaedic research has therefore focused on biologically augmenting the rotator cuff reconstruction and improving tendon–bone healing of the rotator cuff. This biological augmentation has included the application of different platelet concentrates containing growth factors, mesenchymal stem cells, scaffolds and a combination of the above. The present review provides an overview over the biological augmentation options based upon current evidence. PMID:27582941

  15. Multidisciplinary rehabilitation for people with Parkinson's disease: a randomised controlled study

    PubMed Central

    Wade, D; Gage, H; Owen, C; Trend, P; Grossmith, C; Kaye, J

    2003-01-01

    Objective: To determine whether a programme of multidisciplinary rehabilitation and group support achieves sustained benefit for people with Parkinson's disease or their carers. Methods: The study was a randomised controlled crossover trial comparing patients and carers who had received rehabilitation four months before assessment with those who had not. Patients were recruited from a neurology clinic, attended a day hospital from home weekly for six weeks using private car or hospital transport, and received group educational activities and individual rehabilitation from a multidisciplinary team. Patients were assessed at entry and at six months using a 25 item self assessment Parkinson's disease disability questionnaire, Euroqol-5d, SF-36, PDQ-39, hospital anxiety and depression scale, and timed stand-walk-sit test. Carers were assessed using the carer strain index and Euroqol-5d. Results: 144 people with Parkinson's disease without severe cognitive losses and able to travel to hospital were registered (seven were duplicate registrations); 94 had assessments at baseline and six months. Repeated measures analysis of variance comparing patients at the 24 week crossover point showed that those receiving rehabilitation had a trend towards better stand-walk-sit score (p = 0.093) and worse general and mental health (p = 0.002, p = 0.019). Carers of treated patients had a trend towards more strain (p = 0.086). Analysis comparing patients before and six months after treatment showed worsening in disability, quality of life, and carer strain. Conclusions: Patients with Parkinson's disease decline significantly over six months, but a short spell of multidisciplinary rehabilitation may improve mobility. Follow up treatments may be needed to maintain any benefit. PMID:12531939

  16. Telehealth for patients at high risk of cardiovascular disease: pragmatic randomised controlled trial

    PubMed Central

    O’Cathain, Alicia; Thomas, Clare; Edwards, Louisa; Gaunt, Daisy; Dixon, Padraig; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Fahey, Tom; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See; Rogers, Anne; Pope, Catherine; Montgomery, Alan A

    2016-01-01

    Objective To assess whether non-clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies. Design Pragmatic, multicentre, randomised controlled trial. Setting 42 general practices in three areas of England. Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20% or more, no previous cardiovascular event, at least one modifiable risk factor (systolic blood pressure ≥140 mm Hg, body mass index ≥30, current smoker), and access to a telephone, the internet, and email. Participants were individually allocated to intervention (n=325) or control (n=316) groups using automated randomisation stratified by site, minimised by practice and baseline risk score. Interventions Intervention was the Healthlines service (alongside usual care), comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software. Advisors facilitated self management by supporting participants to use online resources to reduce risk factors, and sought to optimise drug use, improve treatment adherence, and encourage healthier lifestyles. The control group comprised usual care alone. Main outcome measures The primary outcome was the proportion of participants responding to treatment, defined as maintaining or reducing their cardiovascular risk after 12 months. Outcomes were collected six and 12 months after randomisation and analysed masked. Participants were not masked. Results 50% (148/295) of participants in the intervention group responded to treatment compared with 43% (124/291) in the control group (adjusted odds ratio 1.3, 95% confidence interval 1.0 to 1.9; number needed to treat=13); a difference possibly due to chance (P=0.08). The intervention was associated with reductions in blood pressure (difference in mean systolic −2.7 mm Hg (95% confidence interval −4.7 to −0.6 mm Hg

  17. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial

    PubMed Central

    Clark, William F; Sontrop, Jessica M; Huang, Shih-Han; Gallo, Kerri; Moist, Louise; House, Andrew A; Weir, Matthew A; Garg, Amit X

    2013-01-01

    Background and objectives Increased water intake may benefit kidney function. Prior to initiating a larger randomised controlled trial (RCT), we examined the safety and feasibility of asking adults with chronic kidney disease (CKD) to increase their water intake. Design, setting, participants and measurements Beginning in October 2012, we randomly assigned 29 adults with stage 3 CKD (estimated glomerular filtration rate (eGFR) 30–60 mL/min/1.73 m2 and albuminuria) to one of the two groups of water intake: hydration (n=18) or standard (n=11). We asked the hydration group to increase their water intake by 1.0–1.5 L/day (in addition to usual intake, depending on sex and weight) for 6 weeks, while the control group carried on with their usual intake. Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after randomisation. Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks. Results (63%)of participants were men, 81% were Caucasians and the average age was 61 years (SD 14 years). The average baseline eGFR was 40 mL/min/1.73 m2 (SD 11 mL/min/1.73 m2); the median albumin to creatinine ratio was 19 mg/mmol (IQR 6–74 mg/mmol). Between baseline and 6-week follow-up, the hydration group's average 24 h urine volume increased by 0.7 L/day (from 2.3 to 3.0 L/day) and the control group's 24 h urine decreased by 0.3 L/day (from 2.0 to 1.7 L/day; between-group difference in change: 0.9 L/day (95% CI 0.4 to 1.5; p=0.002)). We found no significant changes in urine, serum osmolality or electrolyte concentrations, or eGFR. No serious adverse events or changes in quality of life were reported. Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake. Trial registration Registered with Clinical Trials—government identifier NCT01753466. PMID:24362012

  18. Special report: Occlusive cuff controller

    NASA Technical Reports Server (NTRS)

    Baker, J. T.

    1975-01-01

    A mechanical occlusive cuff controller suitable for blood flow experiments in space shuttle flights is described. The device requires 115 volt ac power and a pressurized gas source. Two occluding cuff pressures (30 and 50 mmHg) are selectable by a switch on the front panel. A screw driver adjustment allows accurate cuff pressurization levels for under or oversized limbs. Two pressurization cycles (20 second and 2 minutes) can be selected by a front panel switch. Adjustment of the timing cycles is also available through the front panel. A pushbutton hand switch allows remote start of the cuff inflation cycle. A stop/reset switch permits early termination of the cycle and disabling of the controller to prevent inadvertent reactivation. Pressure in the cuff is monitored by a differential aneroid barometer. In addition, an electrocardiogram trigger circuit permits the initiation of the pressurization cycle by an externally supplied ECG cycle.

  19. Factors affecting rotator cuff healing.

    PubMed

    Mall, Nathan A; Tanaka, Miho J; Choi, Luke S; Paletta, George A

    2014-05-01

    Several studies have noted that increasing age is a significant factor for diminished rotator cuff healing, while biomechanical studies have suggested the reason for this may be an inferior healing environment in older patients. Larger tears and fatty infiltration or atrophy negatively affect rotator cuff healing. Arthroscopic rotator cuff repair, double-row repairs, performing a concomitant acromioplasty, and the use of platelet-rich plasma (PRP) do not demonstrate an improvement in structural healing over mini-open rotator cuff repairs, single-row repairs, not performing an acromioplasty, or not using PRP. There is conflicting evidence to support postoperative rehabilitation protocols using early motion over immobilization following rotator cuff repair. PMID:24806015

  20. Rolling cuff flexible bellows

    DOEpatents

    Lambert, Donald R.

    1985-01-01

    A flexible connector apparatus used to join two stiff non-deformable members, such as piping. The apparatus is provided with one or more flexible sections or assemblies each utilizing a bellows of a rolling cuff type connected between two ridge members, with the bellows being supported by a back-up ring, such that only the curved end sections of the bellows are unsupported. Thus, the bellows can be considered as being of a tube-shaped configuration and thus have high pressure resistance. The components of the flexible apparatus are sealed or welded one to another such that it is fluid tight.

  1. Association between alcohol and cardiovascular disease: Mendelian randomisation analysis based on individual participant data

    PubMed Central

    Holmes, Michael V; Dale, Caroline E; Zuccolo, Luisa; Silverwood, Richard J; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A; Pikhart, Hynek; Swerdlow, Daniel I; Panayiotou, Andrie G; Borinskaya, Svetlana A; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M; Rayaprolu, Sruti; Ross, Owen A; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A; Adamkova, Vera; Flicker, Leon; van Bockxmeer, Frank M; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G; Ferro, Jose M; Paulos-Pinheiro, Sofia; Humphries, Steve E; Talmud, Philippa J; Leach, Irene Mateo; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A; Cramer, Maarten J; van der Harst, Pim; Klungel, Olaf H; Dowling, Nicole F; Dominiczak, Anna F; Kumari, Meena; Nicolaides, Andrew N; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R; Price, Jackie F; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I; Tamosiunas, Abdonas; Maitland-van der Zee, Anke H; Norman, Paul E; Hankey, Graeme J; Bergmann, Manuela M; Hofman, Albert; Franco, Oscar H; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; de Jong, Pim A; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G; Ikram, M Arfan; Ford, Ian; Hyppönen, Elina; Almeida, Osvaldo P; Wareham, Nicholas J; Khaw, Kay-Tee; Hamsten, Anders; Husemoen, Lise Lotte N; Tjønneland, Anne; Tolstrup, Janne S; Rimm, Eric; Beulens, Joline W J; Verschuren, W M Monique; Onland-Moret, N Charlotte; Hofker, Marten H; Wannamethee, S Goya; Whincup, Peter H; Morris, Richard; Vicente, Astrid M; Watkins, Hugh; Farrall, Martin; Jukema, J Wouter; Meschia, James; Cupples, L Adrienne; Sharp, Stephen J; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z; Dai, James Y; Lanktree, Matthew B; Siscovick, David S; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Buxbaum, Sarah G; Schreiner, Pamela J; Ellison, R Curtis; Tsai, Michael Y; Patel, Sanjay R; Redline, Susan; Johnson, Andrew D; Hoogeveen, Ron C; Hakonarson, Hakon; Rotter, Jerome I; Boerwinkle, Eric; de Bakker, Paul I W; Kivimaki, Mika; Asselbergs, Folkert W; Sattar, Naveed; Lawlor, Debbie A; Whittaker, John; Davey Smith, George; Mukamal, Kenneth; Psaty, Bruce M; Wilson, James G; Lange, Leslie A; Hamidovic, Ajna; Hingorani, Aroon D; Nordestgaard, Børge G; Bobak, Martin; Leon, David A; Langenberg, Claudia; Palmer, Tom M; Reiner, Alex P; Keating, Brendan J; Dudbridge, Frank

    2014-01-01

    Objective To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants 261 991 individuals of European descent, including 20 259 coronary heart disease cases and 10 164 stroke events. Data were available on ADH1B rs1229984 variant, alcohol phenotypes, and cardiovascular biomarkers. Main outcome measures Odds ratio for coronary heart disease and stroke associated with the ADH1B variant in all individuals and by categories of alcohol consumption. Results Carriers of the A-allele of ADH1B rs1229984 consumed 17.2% fewer units of alcohol per week (95% confidence interval 15.6% to 18.9%), had a lower prevalence of binge drinking (odds ratio 0.78 (95% CI 0.73 to 0.84)), and had higher abstention (odds ratio 1.27 (1.21 to 1.34)) than non-carriers. Rs1229984 A-allele carriers had lower systolic blood pressure (−0.88 (−1.19 to −0.56) mm Hg), interleukin-6 levels (−5.2% (−7.8 to −2.4%)), waist circumference (−0.3 (−0.6 to −0.1) cm), and body mass index (−0.17 (−0.24 to −0.10) kg/m2). Rs1229984 A-allele carriers had lower odds of coronary heart disease (odds ratio 0.90 (0.84 to 0.96)). The protective association of the ADH1B rs1229984 A-allele variant remained the same across all categories of alcohol consumption (P=0.83 for heterogeneity). Although no association of rs1229984 was identified with the combined subtypes of stroke, carriers of the A-allele had lower odds of ischaemic stroke (odds ratio 0.83 (0.72 to 0.95)). Conclusions Individuals with a genetic variant associated with non-drinking and lower alcohol consumption had a more favourable cardiovascular profile and a reduced risk of coronary heart disease than those without the genetic variant. This suggests that reduction of alcohol consumption, even for light to moderate drinkers, is beneficial for

  2. Alternative vs. conventional treatment given on-demand for gastroesophageal reflux disease: a randomised controlled trial

    PubMed Central

    Farup, Per G; Heibert, Mathis; Høeg, Victor

    2009-01-01

    Background Alternative treatments are commonly used for various disorders and often taken on-demand. On-demand treatment of gastroesophageal reflux disease (GERD) with pharmaceutical products is an established, cost-effective strategy. Comparisons between alternative medicine and pharmaceutical products are rare. The aim of this trial was to compare on-demand treatment with a pectin-based, raft-forming, natural, anti-reflux agent (PRA) with that of esomeprazole 20 mg (Eso20) in patients with mild/moderate GERD. Methods Patients with mild/moderate GERD were randomised to a six weeks' on-demand treatment with PRA or Eso20 in a pragmatic, open, multicentre trial. Overall satisfaction with treatment, satisfactory relief on a weekly basis, reflux symptoms, and treatment preferences were noted. Results Seventy-seven patients were included in the analyses. Eso20 was significantly superior to PRA for proportion of overall satisfied patients (92% and 58% respectively; p = 0.001), reduction of symptoms (mean symptom scores at the end 5.9 and 8.0 respectively; p = 0.019), proportion of weeks of satisfactory relief (89% and 62% respectively; p = 0.008) and proportion preferring continuation with the same treatment (85% and 42% respectively; p < 0.001). Older patients were more satisfied than younger, and patients preferring on-demand treatment had lower symptom scores at inclusion than those preferring regular treatment. Conclusion On-demand treatment with esomeprazole 20 mg was clearly superior to the pectin-based raft-forming agent. Most patients preferred on-demand treatment to regular treatment. Those preferring regular therapy had significantly more symptoms at inclusion. Trial registration ClinicalTrials.gov: NCT00184522. PMID:19236727

  3. Randomised field trial to evaluate serological response after foot-and-mouth disease vaccination in Turkey.

    PubMed

    Knight-Jones, T J D; Bulut, A N; Gubbins, S; Stärk, K D C; Pfeiffer, D U; Sumption, K J; Paton, D J

    2015-02-01

    Despite years of biannual mass vaccination of cattle, foot-and-mouth disease (FMD) remains uncontrolled in Anatolian Turkey. To evaluate protection after mass vaccination we measured post-vaccination antibodies in a cohort of cattle (serotypes O, A and Asia-1). To obtain results reflecting typical field protection, participants were randomly sampled from across Central and Western Turkey after routine vaccination. Giving two-doses one month apart is recommended when cattle are first vaccinated against FMD. However, due to cost and logistics, this is not routinely performed in Turkey, and elsewhere. Nested within the cohort, we conducted a randomised trial comparing post-vaccination antibodies after a single-dose versus a two-dose primary vaccination course. Four to five months after vaccination, only a third of single-vaccinated cattle had antibody levels above a threshold associated with protection. A third never reached this threshold, even at peak response one month after vaccination. It was not until animals had received three vaccine doses in their lifetime, vaccinating every six months, that most (64% to 86% depending on serotype) maintained antibody levels above this threshold. By this time cattle would be >20 months old with almost half the population below this age. Consequently, many vaccinated animals will be unprotected for much of the year. Compared to a single-dose, a primary vaccination course of two-doses greatly improved the level and duration of immunity. We concluded that the FMD vaccination programme in Anatolian Turkey did not produce the high levels of immunity required. Higher potency vaccines are now used throughout Turkey, with a two-dose primary course in certain areas. Monitoring post-vaccination serology is an important component of evaluation for FMD vaccination programmes. However, consideration must be given to which antigens are present in the test, the vaccine and the field virus. Differences between these antigens affect the

  4. Does objective measurement of tracheal tube cuff pressures minimise adverse effects and maintain accurate cuff pressures? A systematic review and meta-analysis.

    PubMed

    Ca, Hockey; Aaj, van Zundert; Jd, Paratz

    2016-09-01

    Correct inflation pressures of the tracheal cuff are recommended to ensure adequate ventilation and prevent aspiration and adverse events. However there are conflicting views on which measurement to employ. The aim of this review was to examine whether adjustment of cuff pressure guided by objective measurement, compared with subjective measurement or observation of the pressure value alone, was able to prevent patient-related adverse effects and maintain accurate cuff pressures. A search of PubMed, Web of Science, Embase, CINAHL and ScienceDirect was conducted using keywords 'cuff pressure' and 'measure*' and related synonyms. Included studies were randomised or pseudo-randomised controlled trials investigating mechanically ventilated patients both in the intensive care unit and during surgery. Outcomes included adverse effects and the comparison of pressure measurements. Pooled analyses were performed to calculate risk ratios, effect sizes and 95% confidence intervals. Meta-analysis found preliminary evidence that adjustment of cuff pressure guided by objective measurement as compared with subjective measurement or observation of the pressure value alone, has benefit in preventing adverse effects. These included cough at two hours (odds ratio [OR] 0.42, confidence interval [CI] 0.23 to 0.79, P=0.007), hoarseness at 24 hours (OR 0.49, CI 0.31 to 0.76, P <0.002), sore throat (OR 0.73, CI 0.54 to 0.97, P <0.03), lesions of the trachea and incidences of silent aspiration (P=0.001), as well as maintaining accurate cuff pressures (Hedges' g 1.61, CI 2.69 to 0.53, P=0.003). Subjective measurement to guide adjustment or observation of the pressure value alone may lead to patient-related adverse effects and inaccuracies. It is recommended that an objective form of measurement be used. PMID:27608338

  5. Does objective measurement of tracheal tube cuff pressures minimise adverse effects and maintain accurate cuff pressures? A systematic review and meta-analysis.

    PubMed

    Hockey, C A; van Zundert, A A J; Paratz, J D

    2016-09-01

    Correct inflation pressures of the tracheal cuff are recommended to ensure adequate ventilation and prevent aspiration and adverse events. However there are conflicting views on which measurement to employ. The aim of this review was to examine whether adjustment of cuff pressure guided by objective measurement, compared with subjective measurement or observation of the pressure value alone, was able to prevent patient-related adverse effects and maintain accurate cuff pressures. A search of PubMed, Web of Science, Embase, CINAHL and ScienceDirect was conducted using keywords 'cuff pressure' and 'measure*' and related synonyms. Included studies were randomised or pseudo-randomised controlled trials investigating mechanically ventilated patients both in the intensive care unit and during surgery. Outcomes included adverse effects and the comparison of pressure measurements. Pooled analyses were performed to calculate risk ratios, effect sizes and 95% confidence intervals. Meta-analysis found preliminary evidence that adjustment of cuff pressure guided by objective measurement as compared with subjective measurement or observation of the pressure value alone, has benefit in preventing adverse effects. These included cough at two hours (odds ratio [OR] 0.42, confidence interval [CI] 0.23 to 0.79, P=0.007), hoarseness at 24 hours (OR 0.49, CI 0.31 to 0.76, P <0.002), sore throat (OR 0.73, CI 0.54 to 0.97, P <0.03), lesions of the trachea and incidences of silent aspiration (P=0.001), as well as maintaining accurate cuff pressures (Hedges' g 1.61, CI 2.69 to 0.53, P=0.003). Subjective measurement to guide adjustment or observation of the pressure value alone may lead to patient-related adverse effects and inaccuracies. It is recommended that an objective form of measurement be used.

  6. Systematic review of randomised controlled trials of multiple risk factor interventions for preventing coronary heart disease.

    PubMed Central

    Ebrahim, S.; Smith, G. D.

    1997-01-01

    OBJECTIVE: To assess the effectiveness of multiple risk factor intervention in reducing cardiovascular risk factors, total mortality, and mortality from coronary heart disease among adults. DESIGN: Systematic review and meta-analysis of randomised controlled trials in workforces and in primary care in which subjects were randomly allocated to more than one of six interventions (stopping smoking, exercise, dietary advice, weight control, antihypertensive drugs, and cholesterol lowering drugs) and followed up for at least six months. SUBJECTS: Adults aged 17-73 years, 903000 person years of observation were included in nine trials with clinical event outcomes and 303000 person years in five trials with risk factor outcomes alone. MAIN OUTCOME MEASURES: Changes in systolic and diastolic blood pressure, smoking rates, blood cholesterol concentrations, total mortality, and mortality from coronary heart disease. RESULTS: Net decreases in systolic and diastolic blood pressure, smoking prevalence, and blood cholesterol were 4.2 mm Hg (SE 0.19 mm Hg), 2.7 mm Hg (0.09 mm Hg), 4.2% (0.3%), and 0.14 mmol/l (0.01 mmol/l) respectively. In the nine trials with clinical event end points the pooled odds ratios for total and coronary heart disease mortality were 0.97 (95% confidence interval 0.92 to 1.02) and 0.96 (0.88 to 1.04) respectively. Statistical heterogeneity between the studies with respect to changes in mortality and risk factors was due to trials focusing on hypertensive participants and those using considerable amounts of drug treatment, with only these trials showing significant reductions in mortality. CONCLUSIONS: The pooled effects of multiple risk factor intervention on mortality were insignificant and a small, but potentially important, benefit of treatment (about a 10% reduction in mortality) may have been missed. Changes in risk factors were modest, were related to the amount of pharmacological treatment used, and in some cases may have been overestimated

  7. Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial

    PubMed Central

    2015-01-01

    Summary Background A systematic assessment of potential disease-modifying compounds for Parkinson's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease. We assessed the effect of pioglitazone on the progression of Parkinson's disease in a multicentre, double-blind, placebo-controlled, futility clinical trial. Methods Participants with the diagnosis of early Parkinson's disease on a stable regimen of 1 mg/day rasagiline or 10 mg/day selegiline were randomly assigned (1:1:1) to 15 mg/day pioglitazone, 45 mg/day pioglitazone, or placebo. Investigators were masked to the treatment assignment. Only the statistical centre and the central pharmacy knew the treatment name associated with the randomisation number. The primary outcome was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline and 44 weeks, analysed by intention to treat. The primary null hypothesis for each dose group was that the mean change in UPDRS was 3 points less than the mean change in the placebo group. The alternative hypothesis (of futility) was that pioglitazone is not meaningfully different from placebo. We rejected the null if there was significant evidence of futility at the one-sided alpha level of 0.10. The study is registered at ClinicalTrials.gov, number NCT01280123. Findings 210 patients from 35 sites in the USA were enrolled between May 10, 2011, and July 31, 2013. The primary analysis included 72 patients in the 15 mg group, 67 in the 45 mg group, and 71 in the placebo group. The mean total UPDRS change at 44 weeks was 4.42 (95% CI 2.55–6.28) for 15 mg pioglitazone, 5.13 (95% CI 3.17–7.08) for 45 mg pioglitazone, and 6.25 (95% CI 4.35–8.15) for placebo (higher change scores are worse). The mean difference between the 15 mg and placebo groups was −1.83 (80% CI −3.56 to −0.10) and the null hypothesis could not be rejected (p=0.19). The mean difference between the 45 mg and placebo

  8. Effect of screening and lifestyle counselling on incidence of ischaemic heart disease in general population: Inter99 randomised trial

    PubMed Central

    Jacobsen, Rikke Kart; Toft, Ulla; Aadahl, Mette; Glümer, Charlotte; Pisinger, Charlotta

    2014-01-01

    Objective To investigate the effect of systematic screening for risk factors for ischaemic heart disease followed by repeated lifestyle counselling on the 10 year development of ischaemic heart disease at a population level. Design Randomised controlled community based trial. Setting Suburbs of Copenhagen, Denmark Participants 59 616 people aged 30-60 years randomised with different age and sex randomisation ratios to an intervention group (n=11 629) and a control group (n=47 987). Intervention The intervention group was invited for screening, risk assessment, and lifestyle counselling up to four times over a five year period. All participants with an unhealthy lifestyle had individually tailored lifestyle counselling at all visits (at baseline and after one and three years); those at high risk of ischaemic heart disease, according to predefined criteria, were furthermore offered six sessions of group based lifestyle counselling on smoking cessation, diet, and physical activity. After five years all were invited for a final counselling session. Participants were referred to their general practitioner for medical treatment, if relevant. The control group was not invited for screening. Main outcome measures The primary outcome measure was incidence of ischaemic heart disease in the intervention group compared with the control group. Secondary outcome measures were stroke, combined events (ischaemic heart disease, stroke, or both), and mortality. Results 6091 (52.4%) people in the intervention group participated at baseline. Among 5978 people eligible at five year follow-up (59 died and 54 emigrated), 4028 (67.4%) attended. A total of 3163 people died in the 10 year follow-up period. Among 58 308 without a history of ischaemic heart disease at baseline, 2782 developed ischaemic heart disease. Among 58 940 without a history of stroke at baseline, 1726 developed stroke. No significant difference was seen between the intervention and control groups in the

  9. Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial

    PubMed Central

    Boland, Melinde R S; Assendelft, Willem J J; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Stijnen, Theo; Blom, Coert; Sont, Jacob K; Rutten-van Mölken, Maureen P H M; Chavannes, Niels H

    2014-01-01

    Objective To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. Design 24 month, multicentre, pragmatic cluster randomised controlled trial Setting 40 general practices in the western part of the Netherlands Participants Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. Intervention General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). Main outcome measures The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. Results Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference –0.01, 95% confidence interval –0.10 to 0.08; P=0.8). After 12 months, no differences

  10. Rotator cuff repair - series (image)

    MedlinePlus

    ... shoulder and arm bones. The tendons can be torn from overuse or injury. ... Surgery to repair a torn rotator cuff is usually very successful at relieving pain in the shoulder. The procedure is less predictable at returning strength ...

  11. Rotator cuff - self-care

    MedlinePlus

    ... rotator cuff is a group of muscles and tendons that attach to the bones of the shoulder ... problems include: Tendinitis , which is irritation of the tendons and inflammation of the bursa (a normally smooth ...

  12. Dietary Advanced Glycation End Products and Risk Factors for Chronic Disease: A Systematic Review of Randomised Controlled Trials

    PubMed Central

    Clarke, Rachel E.; Dordevic, Aimee L.; Tan, Sih Min; Ryan, Lisa; Coughlan, Melinda T.

    2016-01-01

    Dietary advanced glycation end-products (AGEs) form during heating and processing of food products and are widely prevalent in the modern Western diet. Recent systematic reviews indicate that consumption of dietary AGEs may promote inflammation, oxidative stress and insulin resistance. Experimental evidence indicates that dietary AGEs may also induce renal damage, however, this outcome has not been considered in previous systematic reviews. The purpose of this review was to examine the effect of consumption of a high AGE diet on biomarkers of chronic disease, including chronic kidney disease (CKD), in human randomized controlled trials (RCTs). Six databases (SCOPUS, CINHAL, EMBASE, Medline, Biological abstracts and Web of Science) were searched for randomised controlled dietary trials that compared high AGE intake to low AGE intake in adults with and without obesity, diabetes or CKD. Twelve dietary AGE interventions were identified with a total of 293 participants. A high AGE diet increased circulating tumour necrosis factor-alpha and AGEs in all populations. A high AGE diet increased 8-isoprostanes in healthy adults, and vascular cell adhesion molecule-1 (VCAM-1) in patients with diabetes. Markers of CKD were not widely assessed. The evidence presented indicates that a high AGE diet may contribute to risk factors associated with chronic disease, such as inflammation and oxidative stress, however, due to a lack of high quality randomised trials, more research is required. PMID:26938557

  13. The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

    PubMed

    Tew, Garry A; Brabyn, Sally; Cook, Liz; Peckham, Emily

    2016-01-01

    Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11

  14. The Completeness of Intervention Descriptions in Randomised Trials of Supervised Exercise Training in Peripheral Arterial Disease.

    PubMed

    Tew, Garry A; Brabyn, Sally; Cook, Liz; Peckham, Emily

    2016-01-01

    Research supports the use of supervised exercise training as a primary therapy for improving the functional status of people with peripheral arterial disease (PAD). Several reviews have focused on reporting the outcomes of exercise interventions, but none have critically examined the quality of intervention reporting. Adequate reporting of the exercise protocols used in randomised controlled trials (RCTs) is central to interpreting study findings and translating effective interventions into practice. The purpose of this review was to evaluate the completeness of intervention descriptions in RCTs of supervised exercise training in people with PAD. A systematic search strategy was used to identify relevant trials published until June 2015. Intervention description completeness in the main trial publication was assessed using the Template for Intervention Description and Replication checklist. Missing intervention details were then sought from additional published material and by emailing authors. Fifty-eight trials were included, reporting on 76 interventions. Within publications, none of the interventions were sufficiently described for all of the items required for replication; this increased to 24 (32%) after contacting authors. Although programme duration, and session frequency and duration were well-reported in publications, complete descriptions of the equipment used, intervention provider, and number of participants per session were missing for three quarters or more of interventions (missing for 75%, 93% and 80% of interventions, respectively). Furthermore, 20%, 24% and 26% of interventions were not sufficiently described for the mode of exercise, intensity of exercise, and tailoring/progression, respectively. Information on intervention adherence/fidelity was also frequently missing: attendance rates were adequately described for 29 (38%) interventions, whereas sufficient detail about the intensity of exercise performed was presented for only 8 (11

  15. Rotator cuff tear: physical examination and conservative treatment.

    PubMed

    Itoi, Eiji

    2013-03-01

    Rotator cuff tear is one of the most common shoulder diseases. It is interesting that some rotator cuff tears are symptomatic, whereas others are asymptomatic. Pain is the most common symptom of patients with a tear. Even in patients with an asymptomatic tear, it may become symptomatic with an increase in tear size. Physical examination is extremely important to evaluate the presence, location, and extent of a tear. It also helps us to understand the mechanism of pain. Conservative treatment often works. Patients with well-preserved function of the supraspinatus and infraspinatus are the best candidates for conservative treatment. After a successful conservative treatment, the symptom once disappeared may come back again. This recurrence of symptoms is related to tear expansion. Those with high risk of tear expansion and those with less functional rotator cuff muscles are less likely to respond to conservative treatment. They may need a surgical treatment.

  16. Phase 2 Randomised Controlled Trial and Feasibility Study of Future Care Planning in Patients with Advanced Heart Disease

    PubMed Central

    Denvir, Martin A.; Cudmore, Sarah; Highet, Gill; Robertson, Shirley; Donald, Lisa; Stephen, Jacqueline; Haga, Kristin; Hogg, Karen; Weir, Christopher J.; Murray, Scott A.; Boyd, Kirsty

    2016-01-01

    Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost. We assessed the feasibility, acceptability and tested a design of a randomised trial evaluating the impact of FCP in patients and carers. 50 patients hospitalised with acute heart failure or acute coronary syndrome and with predicted 12 month mortality risk of >20% were randomly allocated to FCP or usual care for 12 weeks upon discharge and then crossed-over for the next 12 weeks. Quality of life, symptoms and anxiety/distress were assessed by questionnaire. Hospitalisation and mortality events were documented for 6 months post-discharge. FCP increased implementation and documentation of key decisions linked to end-of-life care. FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94). Quality of life was unchanged (EQ5D: E 0.54(0.29) vs D 0.56(0.24), p = 0.86) while unadjusted hospitalised nights was lower (E 8.6 (15.3) vs D 11.8 (17.1), p = 0.01). Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians. FCP is feasible in a randomised clinical trial in patients with acute high risk cardiac conditions. A Phase 3 trial is needed urgently. PMID:27090299

  17. Classification and treatment of rotator cuff injuries in the overhand athlete.

    PubMed

    Meister, K; Andrews, J R

    1993-08-01

    Rotator cuff injury in athletes results from accumulation of microtrauma to both the static and dynamic stabilizers of the shoulder. Our classification of these injuries and treatment protocol is based on knowledge of the pathophysiology of events leading to rotator cuff failure. Rotator cuff disease is attributed to one of five different modes of failure: primary compressive disease, secondary compressive disease, primary tensile overload, secondary tensile overload, and macrotraumatic injuries. Although disease is categorized based on a single failure mode, there is often significant overlap between the mechanisms of injury leading to the disease. Categorization and, consequently, treatment of the injury rely upon proper identification of the primary pathology and an understanding of the causative factors leading to rotator cuff failure. In most cases conservative management is successful, but, in the refractory cases, minimally invasive surgical techniques have also been successful in returning most athletes to a premorbid level of function.

  18. 21 CFR 868.5760 - Cuff spreader.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5760 Cuff spreader. (a) Identification. A cuff spreader is a device used to install tracheal tube cuffs on tracheal or tracheostomy tubes. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of...

  19. Rotator cuff rehabilitation: current theories and practice.

    PubMed

    Osborne, Jeffrey D; Gowda, Ashok L; Wiater, Brett; Wiater, J Michael

    2016-01-01

    A fully functioning, painless shoulder joint is essential to maintain a healthy, normal quality of life. Disease of the rotator cuff tendons (RCTs) is a common issue that affects the population, increasing with age, and can lead to significant disability and social and health costs. RCT injuries can affect younger, healthy patients and the elderly alike, and may be the result of trauma or occur as a result of chronic degeneration. They can be acutely painful, limited to certain activities or completely asymptomatic and incidental findings. A wide variety of treatment options exists ranging from conservative local and systemic pain modalities, to surgical fixation. Regardless of management ultimately chosen, physiotherapy of the RCT, rotator cuff muscles and surrounding shoulder girdle plays an essential role in proper treatment. Length of treatment, types of therapy and timing may vary if therapy is definitive care or part of a postoperative protocol. Allowing time for adequate RCT healing must always be considered when implementing ROM and strengthening after surgery. With current rehabilitation methods, patients with all spectrums of RCT pathology can improve their function, pain and quality of life. This manuscript reviews current theories and practice involving rehabilitation for RCT injuries.

  20. How reliable are randomised controlled trials for studying the relationship between diet and disease? A narrative review.

    PubMed

    Temple, Norman J

    2016-08-01

    Large numbers of randomised controlled trials (RCT) have been carried out in order to investigate diet-disease relationships. This article examines eight sets of studies and compares the findings with those from epidemiological studies (cohort studies in seven of the cases). The studies cover the role of dietary factors in blood pressure, body weight, cancer and heart disease. In some cases, the findings from the two types of study are consistent, whereas in other cases the findings appear to be in conflict. A critical evaluation of this evidence suggests factors that may account for conflicting findings. Very often RCT recruit subjects with a history of the disease under study (or at high risk of it) and have a follow-up of only a few weeks or months. Cohort studies, in contrast, typically recruit healthy subjects and have a follow-up of 5-15 years. Owing to these differences, findings from RCT are not necessarily more reliable than those from well-designed prospective cohort studies. We cannot assume that the results of RCT can be freely applied beyond the specific features of the studies. PMID:27267302

  1. The role of acromioplasty for management of rotator cuff problems: where is the evidence?

    PubMed

    Shi, Lewis L; Edwards, T Bradley

    2012-01-01

    The incidence of acromioplasty has increased dramatically in recent decades, but its role in rotator cuff surgery has been debated. Neer popularized the extrinsic theory of rotator cuff pathology, where mechanical compression of the coracoacromial arch leads to tearing of the rotator cuff. Under this theory, acromioplasty is advocated to modify acromial morphology as an essential part of rotator cuff surgery. Proponents of the intrinsic theory suggest rotator cuff tendons undergo degeneration through aging and overuse, and that bursectomy alone without acromioplasty is sufficient. There exist cadaveric studies, expert opinions, and numerous case series espousing both sides of the argument. Recently, however, numerous high-quality prospective randomized controlled trials have been published examining the role of acromioplasty. They have similar study design and randomization protocols, including groups of arthroscopic rotator cuff repair with bursectomy and acromioplasty versus isolated bursectomy. The results have been consistent across all studies, with no difference in the outcomes of the acromioplasty and isolated bursectomy groups. Current evidence does not support the routine use of acromioplasty in the treatment of rotator cuff disease. PMID:23316375

  2. Rotator Cuff Tear Shape Characterization

    PubMed Central

    Goodwin, David Steven; Kaplan, Daniel James; Fralinger, David; Gyftopoulos, Soterios; Meislin, Robert J.; Jazrawi, Laith M.

    2016-01-01

    Objectives: Proper surgical planning requires accurate and reliable pre-operative patient information. The more comprehensive the data, the more the surgeon can tailor a general surgical technique to an individual patient’s unique anatomy. A previous retrospective study demonstrated that three-dimensional magnetic resonance imaging more accurately characterized rotator cuff tears compared to two-dimensional images when checked against intra-operative pictures. The purpose of this study was to determine if three-dimensional MRI imaging would continue to be more accurate than two-dimensional imaging in a prospective study. Methods: Patients were prospectively included if they had a full-thickness primary rotator cuff tear on pre-operative MRI. Intra-op videos were taken from the posterior and lateral portals, with a grasper fully mobilizing the torn tendon in each view. 7 surgeons then reviewed the videos and independently characterized the shape of the tears into crescent, U-shaped tears, L-shaped tears, or massive tears. This was considered the gold-standard. Two musculoskeletal radiologists reviewed the corresponding MRI studies independently and blind to the arthroscopic findings and characterized the shape on the basis of the tear’s retraction and size 2D MRI. The 3D reconstructions of each cuff tear were reviewed by each radiologist to characterize the shape. Statistical analysis included 95% confidence intervals and fleiss’s kappa. Results: 37 patients were enrolled in the study. Among the 7 surgeons, agreement on cuff tear was 93% ( =.87). The accuracy for differentiating between crescent-shaped, longitudinal, and massive tears using measurements on 2D MRI was 73.4% for reader 1 and 71.2% for reader 2. The accuracy for tear shape characterization into crescent and longitudinal U- or L-shaped using 3D MRI was 92% for reader 1 and 94% for reader 2. When further characterizing the longitudinal tears as massive or not using 3D MRI, both readers had an

  3. A randomised controlled trial evaluating the effect of an individual auditory cueing device on freezing and gait speed in people with Parkinson's disease

    PubMed Central

    2008-01-01

    Background Parkinson's disease is a progressive neurological disorder resulting from a degeneration of dopamine producing cells in the substantia nigra. Clinical symptoms typically affect gait pattern and motor performance. Evidence suggests that the use of individual auditory cueing devices may be used effectively for the management of gait and freezing in people with Parkinson's disease. The primary aim of the randomised controlled trial is to evaluate the effect of an individual auditory cueing device on freezing and gait speed in people with Parkinson's disease. Methods A prospective multi-centre randomised cross over design trial will be conducted. Forty-seven subjects will be randomised into either Group A or Group B, each with a control and intervention phase. Baseline measurements will be recorded using the Freezing of Gait Questionnaire as the primary outcome measure and 3 secondary outcome measures, the 10 m Walk Test, Timed "Up & Go" Test and the Modified Falls Efficacy Scale. Assessments are taken 3-times over a 3-week period. A follow-up assessment will be completed after three months. A secondary aim of the study is to evaluate the impact of such a device on the quality of life of people with Parkinson's disease using a qualitative methodology. Conclusion The Apple iPod-Shuffle™ and similar devices provide a cost effective and an innovative platform for integration of individual auditory cueing devices into clinical, social and home environments and are shown to have immediate effect on gait, with improvements in walking speed, stride length and freezing. It is evident that individual auditory cueing devices are of benefit to people with Parkinson's disease and the aim of this randomised controlled trial is to maximise the benefits by allowing the individual to use devices in both a clinical and social setting, with minimal disruption to their daily routine. Trial registration The protocol for this study is registered with the US NIH Clinical Trials

  4. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

    PubMed Central

    Svensson, Annemarie Lyng; Løgstrup, Brian Bridal; Giraldi, Annamaria; Graugaard, Christian; Blegvad, Jesper; Thygesen, Tina; Sheetal, Ekta; Svendsen, Lone; Emmertsen, Henrik

    2016-01-01

    Introduction Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. Methods and analysis The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia

  5. Rotator cuff and subacromial pathology.

    PubMed

    Yablon, Corrie M; Jacobson, Jon A

    2015-07-01

    Both MRI and ultrasound (US) demonstrate equivalent accuracy in the evaluation of the rotator cuff. Both modalities have their advantages, disadvantages, and pitfalls. Radiography is an important complementary modality in that it can demonstrate occult sources of shoulder pain. MRI is recommended for the evaluation of shoulder pain in patients < 40 years of age because labral pathology is frequently identified. However, in patients > 40 years, US should be the first-line modality because the incidence of rotator cuff pathology increases with age. US is useful to guide procedures such as subacromial injection and calcific tendinosis lavage. Radiologists should be knowledgeable of both MRI and US of the shoulder to tailor these examinations to the specific needs of their patients.

  6. Ultrasound determination of rotator cuff tear repairability

    PubMed Central

    Tse, Andrew K; Lam, Patrick H; Walton, Judie R; Hackett, Lisa

    2015-01-01

    Background Rotator cuff repair aims to reattach the torn tendon to the greater tuberosity footprint with suture anchors. The present study aimed to assess the diagnostic accuracy of ultrasound in predicting rotator cuff tear repairability and to assess which sonographic and pre-operative features are strongest in predicting repairability. Methods The study was a retrospective analysis of measurements made prospectively in a cohort of 373 patients who had ultrasounds of their shoulder and underwent rotator cuff repair. Measurements of rotator cuff tear size and muscle atrophy were made pre-operatively by ultrasound to enable prediction of rotator cuff repairability. Tears were classified following ultrasound as repairable or irreparable, and were correlated with intra-operative repairability. Results Ultrasound assessment of rotator cuff tear repairability has a sensitivity of 86% (p < 0.0001) and a specificity of 67% (p < 0.0001). The strongest predictors of rotator cuff repairability were tear size (p < 0.001) and age (p = 0.004). Sonographic assessments of tear size ≥4 cm2 or anteroposterior tear length ≥25 mm indicated an irreparable rotator cuff tear. Conclusions Ultrasound assessment is accurate in predicting rotator cuff tear repairability. Tear size or anteroposterior tear length and age were the best predictors of repairability. PMID:27582996

  7. Rotator Cuff Injuries

    MedlinePlus

    ... cold to the sore area Medicines that reduce pain and swelling Electrical stimulation of muscles and nerves Ultrasound Cortisone injection Surgery NIH: National Institute of Arthritis and Musculoskeletal and Skin Disease

  8. Imaging of the Rotator Cuff With Optical Coherence Tomography.

    PubMed

    Hartshorn, Timothy; Ren, Jian; Vangsness, C Thomas

    2015-09-01

    This study evaluated the utility of optical coherence tomography (OCT) in imaging porcine and human rotator cuff (RTC) tissue, analyzed its effectiveness in identifying clinical pathology, and correlated these findings with histologic examination. Twelve human cadaveric and 6 porcine shoulders were evaluated. Six-millimeter-wide bone sections were harvested from the proximal humerus of each specimen, with each containing the entire enthesis of the respective RTC tendon, as well as 2 cm of tendon medial to the enthesis. Only the supraspinatus tendon was evaluated in the human specimens, whereas the enthesis of multiple RTC tendons were evaluated in the porcine model. All specimens were imaged using OCT and correlated with histologic evaluation. Optical coherence tomography evaluation of macroscopically healthy tissue consistently showed an easily identifiable banding pattern (birefringence) in contrast to a disorganized, homogeneous appearance in grossly diseased tissue. Optical coherence tomography was more effective for qualitative evaluation of RTC tissue, identification of bursal-sided RTC tears, and localization of calcific deposits, whereas intrasubstance tendon delaminations and partial articular-sided tendon avulsion lesions were relatively more difficult to identify. Optical coherence tomography correlated well with histologic evaluation in all specimens. Optical coherence tomography provides high-resolution, subsurface imaging of rotator cuff tissue in real-time to a depth of up to 4 mm with excellent correlation to histology in a cadaveric model. Optical coherence tomography could be an effective adjunctive tool for the identification and localization of rotator cuff pathology. The use of OCT in arthroscopic shoulder surgery potentially provides a minimally invasive modality for qualitative assessment of rotator cuff pathology. This may allow for a decrease in soft tissue dissection, improved qualitative assessment of cuff tissue, and improved patient

  9. A randomised trial of peer review: the UK National Chronic Obstructive Pulmonary Disease Resources and Outcomes Project.

    PubMed

    Roberts, C M; Stone, R A; Buckingham, R J; Pursey, N A; Harrison, B D W; Lowe, D; Potter, J M

    2010-06-01

    Peer review has been widely employed within the NHS to facilitate health quality improvement but has not been rigorously evaluated. This article reports the largest randomised trial of peer review ever conducted in the UK. The peer review intervention was a reciprocal supportive exercise that included clinicians, hospital management, commissioners and patients which focused on the quality of the provision of four specific evidence-based aspects of chronic obstructive pulmonary disease care. Follow up at 12 months demonstrated few quantitative differences in the number or quality of services offered in the two groups. Qualitative data in contrast suggested many benefits of peer review in most but not all intervention units and some control teams. Findings suggest peer review in this format is a positive experience for most participants but is ineffective in some situations. Its longer term benefits and cost effectiveness require further study. The generic findings of this study have potential implications for the application of peer review throughout the NHS. PMID:20726448

  10. The effect of gym training on multiple outcomes in Parkinson's disease: a pilot randomised waiting-list controlled trial.

    PubMed

    Poliakoff, Ellen; Galpin, Adam J; McDonald, Kathryn; Kellett, Mark; Dick, Jeremy P R; Hayes, Sue; Wearden, Alison J

    2013-01-01

    There is accumulating evidence for the benefits of exercise in Parkinson's disease (PD), but less is known about group exercise interventions. We evaluated the effect of gym-training programme on people with PD. Thirty-two adults with mild to moderate PD, not currently exercising formally, were randomised to an immediate 20-week biweekly gym training programme at a local leisure complex, or a 10-week programme starting 10 weeks later. Assessments at baseline (T1), 10 weeks (T2) and 20 weeks (T3) included reaction time, motor performance (UPDRS), quality of life and illness perceptions. Experiences of the programme were assessed via questionnaire and a focus group. Overall UPDRS motor function score did not change over time. However, gym training was associated with significant improvements in reaction times and some timed tests in the immediate training group (T1-T2). The delayed group showed similar improvements following gym training (T2-T3). Participants reported enjoyment, obtaining social benefits, and increased confidence. However, the questionnaire measures did not show improvements in subjective health ratings or illness perceptions. Although benefits were not apparent in the questionnaire measures or overall UPDRS scores, our findings suggest that a 10-week gym training programme in a community setting can provide some benefits for people with PD.

  11. Cuff width alters the amplitude envelope of wrist cuff pressure pulse waveforms.

    PubMed

    Jilek, Jiri; Stork, Milan

    2010-07-01

    The accuracy of noninvasive blood pressure (BP) measurement with any method is affected by cuff width. Measurement with a too narrow cuff overestimates BP and measurement with a too wide cuff underestimates BP. Automatic wrist cuff BP monitors use permanently attached narrow cuffs with bladders about 6 cm wide. Such narrow cuffs should result in under-cuffing for wrist circumferences larger than 15 cm. The objective of this qualitative study was to show that a narrow wrist cuff results in increased BP values when a cuff pulse amplitude ratio algorithm is used. According to the algorithm used in this study, systolic pressure (SBP) corresponds to the point of 50% of maximal amplitude; for diastolic pressure (DBP) the ratio is 70%. Data were acquired from 12 volunteers in the sitting position. The mean wrist circumference was 18 cm. The acquired cuff pulse data were used to compute SBP, mean pressure (MAP) and DBP. The mean values for a 6 cm cuff were SBP = 144 mmHg, MAP = 104 mmHg and DBP = 88 mmHg. The values for a 10 cm cuff were SBP = 128 mmHg, MAP = 93 mmHg and DBP = 78 mmHg. The reference BP values were SBP = 132 mmHg, MAP = 96 mmHg and DBP = 80 mmHg. All narrow (6 cm) cuff BP values were higher than wide (10 cm) cuff or reference BP values. The results indicate that wider wrist cuffs may be desirable for more accurate and reliable BP measurement with wrist monitors. PMID:20505218

  12. Cardiorespiratory arrest secondary to tracheostomy cuff herniation

    PubMed Central

    Barker, Ian R; Stotz, Martin

    2013-01-01

    This report details the case of a 67-year-old man who required intubation following a fall and multiple rib fractures and underwent surgical tracheostomy. Postoperatively, he deteriorated on the intensive care unit with airway obstruction. Bronchoscopy demonstrated tracheostomy cuff herniation obstructing airflow necessitating conventional orotracheal reintubation. On inspection of the tracheostomy an unusual cuff deformation was noted. PMID:23988825

  13. 21 CFR 882.5275 - Nerve cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nerve cuff. 882.5275 Section 882.5275 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES Neurological Therapeutic Devices § 882.5275 Nerve cuff. (a) Identification. A nerve...

  14. Rolling-cuff flexible bellows

    DOEpatents

    Lambert, D.R.

    1982-09-27

    A flexible connector apparatus used to join two stiff non-deformable members, such as piping, is described. The apparatus is provided with one or more flexible sections or assemblies each utilizing a bellows of a rolling cuff type connected between two ridge members, with the bellows being supported by a back-up ring, such that only the curved end sections of the bellows are unsupported. Thus, the bellows can be considered as being of a tube-shaped configuration and thus have high pressure resistance. The components of the flexible apparatus are sealed or welded one to another such that it is fluid tight.

  15. Promotion of physical activity and fitness in sedentary patients with Parkinson’s disease: randomised controlled trial

    PubMed Central

    van Nimwegen, Marlies; Speelman, Arlène D; Overeem, Sebastiaan; van de Warrenburg, Bart P; Smulders, Katrijn; Dontje, Manon L; Borm, George F; Backx, Frank J G; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson’s disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Participants 586 sedentary patients with idiopathic Parkinson’s disease aged between 40 and 75 years with mild to moderate disease severity (Hoehn and Yahr stage ≤3). Intervention Patients were randomly assigned to the ParkFit programme or a matched general physiotherapy intervention. ParkFit is a multifaceted behavioural change programme, designed specifically to achieve an enduring increase in the level of physical activity (coaches using motivational strategies; ambulatory feedback). Main outcome measures The primary endpoint was the level of physical activity, measured every six months with a standardised seven day recall (LASA physical activity questionnaire—LAPAQ). Secondary endpoints included two other measures of physical activity (activity diary and ambulatory activity monitor), quality of life (Parkinson’s disease questionnaire—PDQ-39), and fitness (six minute walk test). Results 540 (92.2%) patients completed the primary outcome. During follow-up, overall time spent on physical activities (LAPAQ) was comparable between the groups (adjusted group difference 7%, 95% confidence interval −3 to 17%; P=0.19). Analyses of three secondary outcomes indicated increased physical activity in ParkFit patients, as suggested by the activity diary (difference 30%; P<0.001), the activity monitor (difference 12%; P<0.001), and the six minute walk test (difference 4.8 m; P=0.05). PDQ-39 did not differ between ParkFit patients and controls (difference −0.9 points; P=0.14). The number of fallers was comparable between ParkFit patients (184/299; 62%) and controls (191/287; 67%). Conclusions The ParkFit behavioural change programme did not increase overall physical

  16. A randomised controlled trial investigating the effect of nutritional supplementation on visual function in normal, and age-related macular disease affected eyes: design and methodology [ISRCTN78467674

    PubMed Central

    Bartlett, Hannah; Eperjesi, Frank

    2003-01-01

    Background Age-related macular disease is the leading cause of blind registration in the developed world. One aetiological hypothesis involves oxidation, and the intrinsic vulnerability of the retina to damage via this process. This has prompted interest in the role of antioxidants, particularly the carotenoids lutein and zeaxanthin, in the prevention and treatment of this eye disease. Methods The aim of this randomised controlled trial is to determine the effect of a nutritional supplement containing lutein, vitamins A, C and E, zinc, and copper on measures of visual function in people with and without age-related macular disease. Outcome measures are distance and near visual acuity, contrast sensitivity, colour vision, macular visual field, glare recovery, and fundus photography. Randomisation is achieved via a random number generator, and masking achieved by third party coding of the active and placebo containers. Data collection will take place at nine and 18 months, and statistical analysis will employ Student's t test. Discussion A paucity of treatment modalities for age-related macular disease has prompted research into the development of prevention strategies. A positive effect on normals may be indicative of a role of nutritional supplementation in preventing or delaying onset of the condition. An observed benefit in the age-related macular disease group may indicate a potential role of supplementation in prevention of progression, or even a degree reversal of the visual effects caused by this condition. PMID:14594455

  17. Effects of Oral Lycopene Supplementation on Vascular Function in Patients with Cardiovascular Disease and Healthy Volunteers: A Randomised Controlled Trial

    PubMed Central

    Gajendragadkar, Parag R.; Hubsch, Annette; Mäki-Petäjä, Kaisa M.; Serg, Martin; Wilkinson, Ian B.; Cheriyan, Joseph

    2014-01-01

    Aims The mechanisms by which a ‘Mediterranean diet’ reduces cardiovascular disease (CVD) burden remain poorly understood. Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects. We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately, in healthy volunteers (HV). Methods and Results We randomised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial. Forearm responses to intra-arterial infusions of acetylcholine (endothelium-dependent vasodilatation; EDV), sodium nitroprusside (endothelium-independent vasodilatation; EIDV), and NG-monomethyl-L-arginine (basal nitric oxide (NO) synthase activity) were measured using venous plethysmography. A range of vascular and biochemical secondary endpoints were also explored. EDV in CVD patients post-lycopene improved by 53% (95% CI: +9% to +93%, P = 0.03 vs. placebo) without changes to EIDV, or basal NO responses. HVs did not show changes in EDV after lycopene treatment. Blood pressure, arterial stiffness, lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm. At baseline, CVD patients had impaired EDV compared with HV (30% lower; 95% CI: −45% to −10%, P = 0.008), despite lower LDL cholesterol (1.2 mmol/L lower, 95% CI: −1.6 to −0.9 mmol/L, P<0.001). Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline (2% lower, 95% CI: −30% to +30%, P = 0.85), also suggesting lycopene improved endothelial function. Conclusions Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention, but not in HVs. Trial Registration ClinicalTrials.gov NCT01100385 PMID:24911964

  18. Effects of Anabolic Steroids on Chronic Obstructive Pulmonary Disease: A Meta-Analysis of Randomised Controlled Trials

    PubMed Central

    Guo, Yongzhong

    2014-01-01

    Background Anabolic steroids are known to improve body composition and muscle strength in healthy people. However, whether anabolic steroids improve the physical condition and function in patients with chronic obstructive pulmonary disease (COPD) remains undetermined. A meta-analysis was conducted to review the current evidence regarding the effects of anabolic steroids on COPD patients. Methods A comprehensive literature search of PubMed and EMBASE was performed to identify randomised controlled trials that examine the effects of anabolic steroids on COPD patients. Weighted mean differences (WMDs) with 95% confidence intervals were calculated to determine differences between anabolic steroid administration and control conditions. Results Eight eligible studies involving 273 COPD patients were identified in this meta-analysis. Significant improvements were found in body weight (0.956 kg), fat-free mass (1.606 kg), St. George's Respiratory Questionnaire total score (−6.336) and symptom score (−12.148). The apparent improvements in maximal inspiratory pressure (2.740 cmH2O) and maximal expiratory pressure (12.679 cmH2O) were not significant. The effects on handgrip strength, forced expiratory volume in one second (FEV1), predicted FEV1 percent, PaO2, PaCO2 and six-min walk distance were negative, with WMDs of −0.245 kg, −0.096 L/sec, −1.996% of predicted, −1.648 cmHg, −0.039 cmHg and −16.102 meters, respectively. Conclusions Limited evidence available from the published literature suggests that the benefit of anabolic steroids on COPD patients cannot be denied. However, further studies are needed to identify the specific benefits and adverse effects of anabolic steroids on COPD patients and to determine the optimal populations and regimes of anabolic steroids in COPD patients. PMID:24427297

  19. A Meta-Analysis of Randomised Placebo-Controlled Treatment Trials for Depression and Anxiety in Parkinson’s Disease

    PubMed Central

    Troeung, Lakkhina; Egan, Sarah J.; Gasson, Natalie

    2013-01-01

    Background Psychopharmacotherapy currently constitutes the first-line treatment for depression and anxiety in Parkinson’s disease (PD) however the efficacy of antidepressant treatments in PD is unclear. Several alternative treatments have been suggested as potentially more viable alternatives including dopamine agonists, repetitive transcranial magnetic stimulation, and cognitive behavioural therapy (CBT). Method A meta-analysis of randomised placebo-controlled trials for depression and/or anxiety in PD was conducted to systematically examine the efficacy of current treatments for depression and anxiety in PD. Results Nine trials were included. There was only sufficient data to calculate a pooled effect for antidepressant therapies. The pooled effect of antidepressants for depression in PD was moderate but non-significant (d = .71, 95% CI = −1.33 to 3.08). The secondary effect of antidepressants on anxiety in PD was large but also non-significant (d = 1.13, 95% CI = −.67 to 2.94). Two single-trials of non-pharmacological treatments for depression in PD resulted in significant large effects; Omega-3 supplementation (d = .92, 95% CI = .15 to 1.69) and CBT (d = 1.57, 95% CI = 1.06 to 2.07), and warrant further exploration. Conclusions There remains a lack of controlled trials for both pharmacological and non-pharmacological treatments for depression and anxiety in PD which limits the conclusions which can be drawn. While the pooled effects of antidepressant therapies in PD were non-significant, the moderate to large magnitude of each pooled effect is promising. Non-pharmacological approaches show potential for depression in PD however more research is required. PMID:24236141

  20. Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future disease risk

    PubMed Central

    Kinmonth, Ann Louise; Woodcock, Alison; Griffin, Simon; Spiegal, Nicki; Campbell, Michael J

    1998-01-01

    Objective To assess the effect of additional training of practice nurses and general practitioners in patient centred care on the lifestyle and psychological and physiological status of patients with newly diagnosed type 2 diabetes. Design Pragmatic parallel group design, with randomisation between practice teams to routine care (comparison group) or routine care plus additional training (intervention group); analysis at one year, allowing for practice effects and stratifiers; self reporting by patients on communication with practitioners, satisfaction with treatment, style of care, and lifestyle. Setting 41 practices (21 in intervention group, 20 in comparison group) in a health region in southern England. Subjects 250/360 patients (aged 30-70 years) diagnosed with type 2 diabetes and completing follow up at one year (142 in intervention group, 108 in comparison group). Intervention 1.5 days’ group training for the doctors and nurses—introducing evidence for and skills of patient centred care and a patient held booklet encouraging questions. Main outcome measures Quality of life, wellbeing, haemoglobin A1c and lipid concentrations, blood pressure, body mass index (kg/m2). Results Compared with patients in the C group, those in the intervention group reported better communication with the doctors (odds ratio 2.8; 95% confidence interval 1.8 to 4.3) and greater treatment satisfaction (1.6; 1.1 to 2.5) and wellbeing (difference in means (d) 2.8; 0.4 to 5.2). However, their body mass index was significantly higher (d=2.0; 0.3 to 3.8), as were triglyceride concentrations (d=0.4 mmol/l; 0.07 to 0.73 mmol/l), whereas knowledge scores were lower (d=−2.74; −0.23 to −5.25). Differences in lifestyle and glycaemic control were not significant. Conclusions The findings suggest greater attention to the consultation process than to preventive care among trained practitioners; those committed to achieving the benefits of patient centred consulting should not lose

  1. Randomised trial of erythromycin on the development of chronic lung disease in preterm infants

    PubMed Central

    Lyon, A; McColm, J; Middlemist, L; Fergusson, S; McIntosh, N; Ross, P

    1998-01-01

    AIMS—To determine if erythromycin given from birth reduces the inflammatory response and the incidence and severity of chronic lung disease.
METHODS—Seventy five infants less than 30 weeks of gestation and ventilated from birth for lung disease were randomly assigned to receive erythromycin intravenously for 7 days or to no treatment. Ureaplasma urealyticum was detected in tracheal secretions by culture and polymerase chain reaction. Differential cell counts were obtained from bronchoalveolar lavage fluid collected daily for 5 days and concentrations of the cytokines interluekins IL-1β and IL-8, and tumour necrosis factor α (TNF-α) were measured. Chronic lung disease (CLD) was defined as oxygen dependency at 36 weeks of gestation.
RESULTS—Nine infants (13%) were positive for U urealyticum. The inflammatory cytokines in the lungs increased over the first 5 days of life in all babies, but no association was found between their concentrations and the development of CLD. Those treated with erythromycin showed no significant differences from the non- treated group in the differential cell counts or concentrations of the cytokines. The two groups had a similar incidence of CLD. Babies infected with U urealyticum did not have a more pronounced cytokine response than those without infection. Chorioamnionitis was associated with significantly higher concentrations of IL-1β and IL-8 on admission: these babies had less severe acute lung disease and developed significantly less CLD.
CONCLUSIONS—U urealyticum in the trachea was not associated with an increased inflammatory response in preterm infants. Erythromycin did not reduce the incidence or severity of CLD.

 PMID:9536833

  2. Exacerbations in patients with chronic obstructive pulmonary disease receiving physical therapy: a cohort-nested randomised controlled trial

    PubMed Central

    2014-01-01

    Background Physical exercise training aims at reducing disease-specific impairments and improving quality of life in patients with chronic obstructive pulmonary disease (COPD). COPD exacerbations in particular negatively impact COPD progression. Physical therapy intervention seems indicated to influence exacerbations and their consequences. However, information on the effect of physical therapy on exacerbation occurrence is scarce. This study aims to investigate the potential of a protocol-directed physical therapy programme as a means to prevent or postpone exacerbations, to shorten the duration or to decrease the severity of exacerbations in patients with COPD who have recently experienced an exacerbation. Besides, this study focuses on the effect of protocol-directed physical therapy on health status and quality of life and on cost-effectiveness and cost-utility in patients with COPD who have recently experienced an exacerbation. Methods/Design A prospective cohort of 300 COPD patients in all GOLD stages will be constructed. Patients will receive usual multidisciplinary COPD care including guideline-directed physical therapy. Patients in this cohort who have GOLD stage 2 to 4 (post-bronchodilator FEV1/FVC < 0.7 and FEV1 < 80% of predicted), who receive reimbursement by health insurance companies for physical therapy (post-bronchodilator Tiffeneau-index < 0.6) and who experience a COPD exacerbation will be asked within 56 days to participate in a cohort-nested prospective randomised controlled trial (RCT). In this RCT, the intervention group will receive a strict physical therapy programme for patients with COPD. This protocol-directed physical therapy (pdPT) will be compared to a control group that will receive sham-treatment, meaning no or very low-intensity exercise training (ST). An economic evaluation will be embedded in the RCT. Anthropometric measurements, comorbidities, smoking, functional exercise capacity, peripheral muscle strength

  3. Results and lessons from the Spironolactone To Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (STOP-CKD) randomised controlled trial

    PubMed Central

    Ng, Khai P; Jain, Poorva; Gill, Paramjit S; Heer, Gurdip; Townend, Jonathan N; Freemantle, Nick; Greenfield, Sheila; Ferro, Charles J

    2016-01-01

    Objectives To determine whether low-dose spironolactone can safely lower arterial stiffness in patients with chronic kidney disease stage 3 in the primary care setting. Design A multicentre, prospective, randomised, placebo-controlled, double-blinded study. Setting 11 primary care centres in South Birmingham, England. Participants Adult patients with stage 3 chronic kidney disease. Main exclusion criteria were diagnosis of diabetes mellitus, chronic heart failure, atrial fibrillation, severe hypertension, systolic blood pressure <120 mm Hg or baseline serum potassium ≥5 mmol/L. Intervention Eligible participants were randomised to receive either spironolactone 25 mg once daily, or matching placebo for an intended period of 40 weeks. Outcome measures The primary end point was the change in arterial stiffness as measured by pulse wave velocity. Secondary outcome measures included the rate of hyperkalaemia, deterioration of renal function, barriers to participation and expected recruitment rates to a potential future hard end point study. Results From the 11 practices serving a population of 112 462, there were 1598 (1.4%) patients identified as being eligible and were invited to participate. Of these, 134 (8.4%) attended the screening visit of which only 16 (1.0%) were eligible for randomisation. The main reasons for exclusion were low systolic blood pressure (<120 mm Hg: 40 patients) and high estimated glomerular filtration rate (≥60 mL/min/1.73 m2: 38 patients). The trial was considered unfeasible and was terminated early. Conclusions We highlight some of the challenges in undertaking research in primary care including patient participation in trials. This study not only challenged our preconceptions, but also provided important learning for future research in this large and important group of patients. Trial registration number ISRCTN80658312. PMID:26916697

  4. Rotator cuff injuries in adolescent athletes.

    PubMed

    Weiss, Jennifer M; Arkader, Alexandre; Wells, Lawrence M; Ganley, Theodore J

    2013-03-01

    The cause of rotator cuff injuries in the young athlete has been described as an overuse injury related to internal impingement. Abduction coupled with external rotation is believed to impinge on the rotator cuff, specifically the supraspinatus, and lead to undersurface tears that can progress to full-thickness tears. This impingement is believed to be worsened with increased range of motion and instability in overhead athletes. A retrospective review of seven patients diagnosed with rotator cuff injuries was performed to better understand this shoulder injury pattern. The type of sport played, a history of trauma, diagnosis, treatment method, and outcome were noted. Six patients were male and one was a female. Baseball was the primary sport for four patients, basketball for one, gymnastics for one, and wrestling for one. The following injury patterns were observed: two patients tore their subscapularis tendon, two sustained avulsion fractures of their lesser tuberosity, one tore his rotator interval, one tore his supraspinatus, and one avulsed his greater tuberosity. Only four patients recalled a specific traumatic event. Three patients were treated with arthroscopic rotator cuff repair, three with miniopen repair, and one was treated with rehabilitation. Six of the seven patients returned to their preinjury level of sport after treatment. Rotator cuff tears are rare in the adolescent age group. The injury patterns suggest that acute trauma likely accounts for many rotator cuff tears and their equivalents in the young patient. Adolescents with rotator cuff tears reliably return to sports after treatment. The possibility of rotator cuff tears in skeletally immature athletes should be considered. The prognosis is very good once this injury is identified and treated. PMID:22668571

  5. Rotator cuff injuries in adolescent athletes.

    PubMed

    Weiss, Jennifer M; Arkader, Alexandre; Wells, Lawrence M; Ganley, Theodore J

    2013-03-01

    The cause of rotator cuff injuries in the young athlete has been described as an overuse injury related to internal impingement. Abduction coupled with external rotation is believed to impinge on the rotator cuff, specifically the supraspinatus, and lead to undersurface tears that can progress to full-thickness tears. This impingement is believed to be worsened with increased range of motion and instability in overhead athletes. A retrospective review of seven patients diagnosed with rotator cuff injuries was performed to better understand this shoulder injury pattern. The type of sport played, a history of trauma, diagnosis, treatment method, and outcome were noted. Six patients were male and one was a female. Baseball was the primary sport for four patients, basketball for one, gymnastics for one, and wrestling for one. The following injury patterns were observed: two patients tore their subscapularis tendon, two sustained avulsion fractures of their lesser tuberosity, one tore his rotator interval, one tore his supraspinatus, and one avulsed his greater tuberosity. Only four patients recalled a specific traumatic event. Three patients were treated with arthroscopic rotator cuff repair, three with miniopen repair, and one was treated with rehabilitation. Six of the seven patients returned to their preinjury level of sport after treatment. Rotator cuff tears are rare in the adolescent age group. The injury patterns suggest that acute trauma likely accounts for many rotator cuff tears and their equivalents in the young patient. Adolescents with rotator cuff tears reliably return to sports after treatment. The possibility of rotator cuff tears in skeletally immature athletes should be considered. The prognosis is very good once this injury is identified and treated.

  6. Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial

    PubMed Central

    Myers, Stephen P.; Rolfe, Margaret

    2016-01-01

    Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD) reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD). The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup. Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™ probiotic formulation (n = 23) or 5 g placebo (n = 22) orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events. Results. SPSS™ multivariate repeated measures analysis (95th confidence level) revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study. Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials Register ACTRN12610000630011. PMID:27525027

  7. Probiotics and the Microbiome in Celiac Disease: A Randomised Controlled Trial.

    PubMed

    Harnett, Joanna; Myers, Stephen P; Rolfe, Margaret

    2016-01-01

    Background. There is limited research investigating the composition of the gastrointestinal microbiota in individuals with celiac disease (CoeD) reporting only partial symptom improvement despite adherence to a strict gluten-free diet (GFD). The aim of this research was to determine if the gastrointestinal microbiota could be altered by probiotic bacteria and provide a potential new therapy for this subgroup. Methods. A multicentre RCT was conducted between January and August 2011 in Australia. Participants included 45 people with CoeD reporting only partial symptom improvement despite adherence to a strict GFD for a minimum of 12 months. Participants took 5 g of VSL#™ probiotic formulation (n = 23) or 5 g placebo (n = 22) orally twice daily for 12 weeks. The main outcome measured was the efficacy of the probiotic formula in altering faecal microbiota counts between baseline and week 12. Safety was determined by safety blood and monitoring adverse events. Results. SPSS™ multivariate repeated measures analysis (95th confidence level) revealed no statistically significant changes between the groups in the faecal microbiota counts or blood safety measures over the course of the study. Conclusion. The probiotic formula when taken orally over the 12-week period did not significantly alter the microbiota measured in this population. The trial was registered with Australian and New Zealand Clinical Trials Register ACTRN12610000630011. PMID:27525027

  8. Electrosurgical Settings and Vaginal Cuff Complications

    PubMed Central

    Lawlor, Megan L.; Rao, Rama; Manahan, Kelly J.

    2015-01-01

    Background and Objectives: After being encouraged to change the technique for opening the vaginal cuff during robotic surgery, this study was performed to determine the correlation between vaginal cuff complications and electrosurgical techniques. Methods: The study group consisted of patients who had their vaginal cuffs opened with a cutting current compared to the group of patients having their vaginal cuff opened with a coagulation current. Data were collected on 150 women who underwent robotic surgery for endometrial cancer. All patients received preoperative antibiotics. Data, including operative time, type of electrosurgery used, estimated blood loss, transfusion rate, and complications, were collected from the patients' records. Results: Surgeries in 150 women and the associated complications were studied. The mean age of the patients was not significantly different between the groups (P = .63). The mean body mass index was 38 kg/m2 in the coagulation arm and 36 kg/m2 in the cutting arm (P = .03). Transfusion was not required. Estimated blood loss and operative time were not significantly different in the coagulation versus the cutting arms (P = .29 and .5; respectively). No patients in the cutting arm and 4 patients (with 5 complications) in the coagulation arm had cuff complications (P = .02). Conclusions: Complications involving the vaginal cuff appear to occur more frequently when the vagina is entered by using electrosurgery with coagulation versus cutting in this cohort of patients undergoing robot-assisted surgery for endometrial cancer.. PMID:26681912

  9. Scaffold devices for rotator cuff repair.

    PubMed

    Ricchetti, Eric T; Aurora, Amit; Iannotti, Joseph P; Derwin, Kathleen A

    2012-02-01

    Rotator cuff tears affect 40% or more of those aged older than 60 years, and repair failure rates of 20% to 70% remain a significant clinical challenge. Hence, there is a need for repair strategies that can augment the repair by mechanically reinforcing it, while at the same time biologically enhancing the intrinsic healing potential of the tendon. Tissue engineering strategies to improve rotator cuff repair healing include the use of scaffolds, growth factors, and cell seeding, or a combination of these approaches. Currently, scaffolds derived from mammalian extracellular matrix, synthetic polymers, and a combination thereof, have been cleared by the U.S. Food and Drug Administration and are marketed as medical devices for rotator cuff repair in humans. Despite the growing clinical use of scaffold devices for rotator cuff repair, there are numerous questions related to their indication, surgical application, safety, mechanism of action, and efficacy that remain to be clarified or addressed. This article reviews the current basic science and clinical understanding of commercially available synthetic and extracellular matrix scaffolds for rotator cuff repair. Our review will emphasize the host response and scaffold remodeling, mechanical and suture-retention properties, and preclinical and clinical studies on the use of these scaffolds for rotator cuff repair. We will discuss the implications of these data on the future directions for use of these scaffolds in tendon repair procedures.

  10. Blindness and eye diseases in Tibet: findings from a randomised, population based survey

    PubMed Central

    Dunzhu, S; Wang, F S; Courtright, P; Liu, L; Tenzing, C; Noertjojo, K; Wilkie, A; Santangelo, M; Bassett, K L

    2003-01-01

    Background: Public health officials of the Tibet Autonomous Region (TAR) of China requested a survey of blindness, eye diseases, and eye care service utilisation to assist the development of a 10 year blindness prevention and treatment plan. The objective of the survey was to determine the prevalence of blindness and visual impairment, as well as cataract surgical coverage and surgical outcome in the TAR. Methods: The Tibet Eye Care Assessment was a cross sectional prevalence study of three of the seven prefectures (provinces) of the TAR (Lhoka, Nakchu, and Lingzhr) selected to represent its three main environmental regions. The survey sample was selected using a random multistage cluster method. Two teams conducted the survey in a standardised fashion in each prefecture, Lhoka during May and Nakchu during June 1999, and Lingzhr during May 2000. Visual acuity, cause of vision loss, trachoma, and vitamin A deficiency were included in the clinical examination. Results: Among the 15 900 people enumerated, 12 644 were examined for an overall response rate of 79.6%. The crude prevalence of blindness (presenting better eye visual acuity of less than 6/60) was 2.3%; age and sex adjusted blindness prevalence was 1.4% (95% CI 1.3 to 1.5). Visual impairment (better eye presenting visual acuity of 6/24 to 6/60) was found in 10.9% (95% CI 10.5 to 11.2) of the population (age and sex adjusted). Cataract was the primary cause of blindness (50.7%), followed by macular degeneration (12.7%) and corneal opacity (9.7%). Conclusion: Blindness is a serious public health problem in Tibet, with prevalence higher than in similar studies in eastern China. As elsewhere in the world, women have an excess burden of blindness compared to men. About 75% of blindness in Tibet can be either prevented or treated. Eye care planning for Tibet must focus on cataract, particularly among women. PMID:14660448

  11. Cost-effectiveness of telehealth for patients with raised cardiovascular disease risk: evidence from the Healthlines randomised controlled trial

    PubMed Central

    Dixon, Padraig; Edwards, Louisa; Thomas, Clare; Gaunt, Daisy; Foster, Alexis; Large, Shirley; Montgomery, Alan A

    2016-01-01

    Objectives To investigate the cost-effectiveness of a telehealth intervention for primary care patients with raised cardiovascular disease (CVD) risk. Design A prospective within-trial patient-level economic evaluation conducted alongside a randomised controlled trial. Setting Patients recruited through primary care, and intervention delivered via telehealth service. Participants Adults with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, with at least 1 modifiable risk factor. Intervention A series of up to 13 scripted, theory-led telehealth encounters with healthcare advisors, who supported participants to make behaviour change, use online resources, optimise medication and improve adherence. Participants in the control arm received usual care. Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit at the end of 12 months of follow-up, calculated from incremental cost and incremental quality-adjusted life years (QALYs). Productivity impacts, participant out-of-pocket expenditure and the clinical outcome were presented in a cost-consequences framework. Results 641 participants were randomised—325 to receive the telehealth intervention in addition to usual care and 316 to receive only usual care. 18% of participants had missing data on either costs, utilities or both. Multiple imputation was used for the base case results. The intervention was associated with incremental mean per-patient National Health Service (NHS) costs of £138 (95% CI 66 to 211) and an incremental QALY gain of 0.012 (95% CI −0.001 to 0.026). The incremental cost-effectiveness ratio was £10 859. Net monetary benefit at a cost-effectiveness threshold of £20 000 per QALY was £116 (95% CI −58 to 291), and the probability that the intervention was cost-effective at this threshold value was 0.77. Similar results were obtained from a complete case analysis. Conclusions There is evidence to suggest that the Healthlines telehealth

  12. Change in endotracheal tube cuff pressure during nitrous oxide anaesthesia: a comparison between air and distilled water cuff inflation.

    PubMed

    Ahmad, N L; Norsidah, A M

    2001-10-01

    In this prospective, randomized controlled trial, changes in endotracheal tube cuff pressure were studied in 60 patients undergoing elective surgery under general anaesthesia with nitrous oxide and oxygen. The cuffs were inflated with either air or distilled water. The mean pressure in the air-filled cuffs increased steadily throughout the procedure, reaching 47.5 +/- 7.3 cmH2O at one hour compared with 31.6 +/- 2.4 cmH2O mean pressure in the water-filled cuffs. The pressure and the rate of rise in cuff pressure were significantly lower (P<0.05) in the water-filled cuffs throughout the hour of study. When an endotracheal tube cuff is distended with water, the rise in cuff pressure during nitrous oxide anaesthesia is lower than that of an air-filled cuff.

  13. No Effect of Omega-3 Fatty Acid Supplementation on Cognition and Mood in Individuals with Cognitive Impairment and Probable Alzheimer’s Disease: A Randomised Controlled Trial

    PubMed Central

    Phillips, Michelle A.; Childs, Caroline E.; Calder, Philip C.; Rogers, Peter J.

    2015-01-01

    Findings from epidemiological and observational studies have indicated that diets high in omega-3 polyunsaturated fatty acids (PUFAs) such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) may reduce the risk of cognitive decline and Alzheimer’s disease (AD). To determine if increasing intake of DHA and EPA through supplementation is beneficial to cognition and mood in individuals with cognitive impairment no dementia (CIND) or Alzheimer’s disease (AD) a four month, randomised, double-blind, placebo controlled study was conducted. Fifty-seven participants with CIND and nineteen with AD were randomised to receive either omega-3 PUFAs (600 mg EPA and 625 mg DHA per day) or placebo (olive oil) over a four month period. Elevating depleted levels of EPA and DHA through supplementation in individuals with CIND or AD was found to have negligible beneficial effect on their cognition or mood. These findings confirm an overall negligible benefit of omega-3 PUFA supplementation for those with cognitive impairment and dementia. More intervention studies need to be undertaken with longer study durations and larger sample sizes. It may prove fruitful to examine effects of different doses as well as effects in other dementia subtypes. PMID:26501267

  14. No Effect of Omega-3 Fatty Acid Supplementation on Cognition and Mood in Individuals with Cognitive Impairment and Probable Alzheimer's Disease: A Randomised Controlled Trial.

    PubMed

    Phillips, Michelle A; Childs, Caroline E; Calder, Philip C; Rogers, Peter J

    2015-01-01

    Findings from epidemiological and observational studies have indicated that diets high in omega-3 polyunsaturated fatty acids (PUFAs) such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) may reduce the risk of cognitive decline and Alzheimer's disease (AD). To determine if increasing intake of DHA and EPA through supplementation is beneficial to cognition and mood in individuals with cognitive impairment no dementia (CIND) or Alzheimer's disease (AD) a four month, randomised, double-blind, placebo controlled study was conducted. Fifty-seven participants with CIND and nineteen with AD were randomised to receive either omega-3 PUFAs (600 mg EPA and 625 mg DHA per day) or placebo (olive oil) over a four month period. Elevating depleted levels of EPA and DHA through supplementation in individuals with CIND or AD was found to have negligible beneficial effect on their cognition or mood. These findings confirm an overall negligible benefit of omega-3 PUFA supplementation for those with cognitive impairment and dementia. More intervention studies need to be undertaken with longer study durations and larger sample sizes. It may prove fruitful to examine effects of different doses as well as effects in other dementia subtypes. PMID:26501267

  15. Occult Interpositional Rotator Cuff - an Extremely Rare Case of Traumatic Rotator Cuff Tear

    PubMed Central

    Lin, Cheng-Li; Su, Wei-Ren; Jou, I-Ming

    2012-01-01

    Traumatic interposition of a rotator cuff tendon in the glenohumeral joint without recognizable glenohumeral dislocation is an unusual complication after shoulder trauma. Here we report the clinical and imaging presentations of a 17-year-old man with trapped rotator cuff tendons in the glenohumeral joint after a bicycle accident. The possible trauma mechanism is also discussed. PMID:22247643

  16. The Effect of Souvenaid on Functional Brain Network Organisation in Patients with Mild Alzheimer’s Disease: A Randomised Controlled Study

    PubMed Central

    de Waal, Hanneke; Stam, Cornelis J.; Lansbergen, Marieke M.; Wieggers, Rico L.; Kamphuis, Patrick J. G. H.; Scheltens, Philip; Maestú, Fernando; van Straaten, Elisabeth C. W.

    2014-01-01

    Background Synaptic loss is a major hallmark of Alzheimer’s disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. Objective To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. Design A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. Participants 179 drug-naïve mild AD patients who participated in the Souvenir II study. Intervention Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. Outcome In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance. Results The network measures in the beta band were significantly different between groups: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. Conclusions The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG

  17. Effects of vitamin D supplementation on intestinal permeability, cathelicidin and disease markers in Crohn’s disease: Results from a randomised double-blind placebo-controlled study

    PubMed Central

    Raftery, Tara; Martineau, Adrian R; Greiller, Claire L; Ghosh, Subrata; McNamara, Deirdre; Bennett, Kathleen; Meddings, Jon

    2015-01-01

    Background Vitamin D (vitD) supplementation may prolong remission in Crohn’s disease (CD); however, the clinical efficacy and mechanisms are unclear. Aim To determine changes in intestinal permeability (IP), antimicrobial peptide (AMP) concentrations and disease markers in CD, in response to vitD supplementation. Methods In a double-blind randomised placebo-controlled study, we assigned 27 CD patients in remission to 2000 IU/day vitD or placebo for 3 mos. We determined IP, plasma cathelicidin (LL-37 in ng/mL), human-beta-defensin-2 (hBD2 in pg/mL), disease activity (Crohn’s Disease Activity Index (CDAI)), C-reactive protein (CRP in mg/L), fecal calprotectin (µg/g), Quality of Life (QoL) and serum 25-hydroxyvitamin D (25(OH)D in nmol/L) at 0 and 3 mos. Results At 3 mos., 25(OH)D concentrations were significantly higher in those whom were treated (p < 0.001). Intra-group analysis showed increased LL-37 concentrations (p = 0.050) and maintenance of IP measures in the treated group. In contrast, in the placebo group, the small bowel (p = 0.018) and gastro-duodenal permeability (p = 0.030) increased from baseline. At 3 mos., patients with 25(OH)D ≥ 75 nmol/L had significantly lower CRP (p = 0.019), higher QoL (p = 0.037), higher LL-37 concentrations (p < 0.001) and non-significantly lower CDAI scores (p = 0.082), compared to those with levels <75 nmol/L. Conclusion Short-term treatment with 2000 IU/day vitD significantly increased 25(OH)D levels in CD patients in remission and it was associated with increased LL-37 concentrations and maintenance of IP. Achieving 25(OH)D ≥ 75 nmol/l was accompanied by higher circulating LL-37, higher QoL scores and reduced CRP. Registered at ClinicalTrials.gov (NCT01792388). PMID:26137304

  18. β-Blockers for the prevention of acute exacerbations of chronic obstructive pulmonary disease (βLOCK COPD): a randomised controlled study protocol

    PubMed Central

    Bhatt, Surya P; Connett, John E; Voelker, Helen; Lindberg, Sarah M; Westfall, Elizabeth; Wells, J Michael; Lazarus, Stephen C; Criner, Gerard J; Dransfield, Mark T

    2016-01-01

    Introduction A substantial majority of chronic obstructive pulmonary disease (COPD)-related morbidity, mortality and healthcare costs are due to acute exacerbations, but existing medications have only a modest effect on reducing their frequency, even when used in combination. Observational studies suggest β-blockers may reduce the risk of COPD exacerbations; thus, we will conduct a randomised, placebo-controlled trial to definitively assess the impact of metoprolol succinate on the rate of COPD exacerbations. Methods and analyses This is a multicentre, placebo-controlled, double-blind, prospective randomised trial that will enrol 1028 patients with at least moderately severe COPD over a 3-year period. Participants with at least moderate COPD will be randomised in a 1:1 fashion to receive metoprolol or placebo; the cohort will be enriched for patients at high risk for exacerbations. Patients will be screened and then randomised over a 2-week period and will then undergo a dose titration period for the following 6 weeks. Thereafter, patients will be followed for 42 additional weeks on their target dose of metoprolol or placebo followed by a 4-week washout period. The primary end point is time to first occurrence of an acute exacerbation during the treatment period. Secondary end points include rates and severity of COPD exacerbations; rate of major cardiovascular events; all-cause mortality; lung function (forced expiratory volume in 1 s (FEV1)); dyspnoea; quality of life; exercise capacity; markers of cardiac stretch (pro-NT brain natriuretic peptide) and systemic inflammation (high-sensitivity C reactive protein and fibrinogen). Analyses will be performed on an intent-to-treat basis. Ethics and dissemination The study protocol has been approved by the Department of Defense Human Protection Research Office and will be approved by the institutional review board of all participating centres. Study findings will be disseminated through presentations at national

  19. Healthy Ageing Through Internet Counselling in the Elderly: the HATICE randomised controlled trial for the prevention of cardiovascular disease and cognitive impairment

    PubMed Central

    Richard, Edo; Jongstra, Susan; Soininen, Hilkka; Brayne, Carol; Moll van Charante, Eric P; Meiller, Yannick; van der Groep, Bram; Beishuizen, Cathrien R L; Mangialasche, Francesca; Barbera, Mariagnese; Ngandu, Tiia; Coley, Nicola; Guillemont, Juliette; Savy, Stéphanie; Dijkgraaf, Marcel G W; Peters, Ron J G; van Gool, Willem A; Kivipelto, Miia; Andrieu, Sandrine

    2016-01-01

    Introduction Cardiovascular disease and dementia share a number of risk factors including hypertension, hypercholesterolaemia, smoking, obesity, diabetes and physical inactivity. The rise of eHealth has led to increasing opportunities for large-scale delivery of prevention programmes encouraging self-management. The aim of this study is to investigate whether a multidomain intervention to optimise self-management of cardiovascular risk factors in older individuals, delivered through an coach-supported interactive internet platform, can improve the cardiovascular risk profile and reduce the risk of cardiovascular disease and cognitive decline. Methods and analysis HATICE is a multinational, multicentre, prospective, randomised, open-label blinded end point (PROBE) trial with 18 months intervention. Recruitment of 2600 older people (≥65 years) at increased risk of cardiovascular disease will take place in the Netherlands, Finland and France. Participants randomised to the intervention condition will have access to an interactive internet platform, stimulating self-management of vascular risk factors, with remote support by a coach. Participants in the control group will have access to a static internet platform with basic health information. The primary outcome is a composite score based on the average z-score of the difference between baseline and 18 months follow-up values of systolic blood pressure, low-density-lipoprotein and body mass index. Main secondary outcomes include the effect on the individual components of the primary outcome, the effect on lifestyle-related risk factors, incident cardiovascular disease, mortality, cognitive functioning, mood and cost-effectiveness. Ethics and dissemination The study was approved by the medical ethics committee of the Academic Medical Center in Amsterdam, the Comité de Protection des Personnes Sud Ouest et Outre Mer in France and the Northern Savo Hospital District Research Ethics Committee in Finland. We

  20. Rotator Cuff Tendinitis and Tear (Beyond the Basics)

    MedlinePlus

    ... is usually treated with ice, antiinflammatory drugs, and physical therapy. (See 'Rotator cuff injury treatment' below.) Rotator cuff ... small- to medium-size tears usually improve with physical therapy exercises, stopping painful activities, and, in some cases, ...

  1. Cost-effectiveness modelling of telehealth for patients with raised cardiovascular disease risk: evidence from a cohort simulation conducted alongside the Healthlines randomised controlled trial

    PubMed Central

    Dixon, Padraig; Ara, Roberta; Edwards, Louisa; Foster, Alexis

    2016-01-01

    Objectives To investigate the long-term cost-effectiveness (measured as the ratio of incremental NHS cost to incremental quality-adjusted life years) of a telehealth intervention for patients with raised cardiovascular disease (CVD) risk. Design A cohort simulation model developed as part of the economic evaluation conducted alongside the Healthlines randomised controlled trial. Setting Patients recruited through primary care, and intervention delivered via telehealth service. Participants Participants with a 10-year CVD risk ≥20%, as measured by the QRISK2 algorithm, and with at least 1 modifiable risk factor, individually randomised from 42 general practices in England. Intervention A telehealth service delivered over a 12-month period. The intervention involved a series of responsive, theory-led encounters between patients and trained health information advisors who provided access to information resources and supported medication adherence and coordination of care. Primary and secondary outcome measures Cost-effectiveness measured by net monetary benefit over the simulated lifetime of trial participants from a UK National Health Service perspective. Results The probability that the intervention was cost-effective depended on the duration of the effect of the intervention. The intervention was cost-effective with high probability if effects persisted over the lifetime of intervention recipients. The probability of cost-effectiveness was lower for shorter durations of effect. Conclusions The intervention was likely to be cost-effective under a lifetime perspective. Trial registration number ISRCTN27508731; Results. PMID:27670521

  2. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  3. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  4. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  5. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  6. 21 CFR 870.1120 - Blood pressure cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Blood pressure cuff. 870.1120 Section 870.1120...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1120 Blood pressure cuff. (a) Identification. A blood pressure cuff is a device that has an inflatable bladder in an...

  7. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  8. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  9. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  10. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  11. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  12. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  13. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  14. 21 CFR 868.5800 - Tracheostomy tube and tube cuff.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Tracheostomy tube and tube cuff. 868.5800 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5800 Tracheostomy tube and tube cuff. (a) Identification. A tracheostomy tube and tube cuff is a device intended to be placed into...

  15. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  16. 21 CFR 868.5750 - Inflatable tracheal tube cuff.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Inflatable tracheal tube cuff. 868.5750 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5750 Inflatable tracheal tube cuff. (a) Identification. An inflatable tracheal tube cuff is a device used to provide an airtight...

  17. Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

    PubMed Central

    Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

    2013-01-01

    Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person

  18. Identification of a Very High Cuff Pressure by Manual Palpation of the External Cuff Balloon on an Endotracheal Tube.

    PubMed

    Hedberg, Pia; Eklund, Carolina; Högqvist, Sandra

    2015-06-01

    The most common complication due to intubation is a high cuff pressure. A high cuff pressure can cause postanesthetic tracheal mucosal injuries in patients undergoing surgery. The aim of this cross-sectional study was to describe whether anesthetic nurses and anesthesiologists identified a very high cuff pressure by manual palpation of the external cuff balloon on an endotracheal tube. An airway device was intubated with an endotracheal tube cuffed to 95 cm H2O. Each participant palpated the external cuff balloon and then filled out a questionnaire, including estimation of the cuff pressure and user frequency of the cuff pressure manometer. The results showed that 89.1% estimated that the cuff pressure was high. Among the participants who rated the cuff pressure as high, 44.8% rated the pressure as quite high and 60.6% rated the pressure as very high. There was no significant relationship between profession and skill in identifying a very high cuff pressure (P = .843) or between work experience and skill in terms of identifying a very high cuff pressure (P = .816). These findings indicate that 10% of patients are at risk of tracheal erosion because of a high cuff pressure.

  19. The role of 25-hydroxyvitamin D deficiency in promoting insulin resistance and inflammation in patients with Chronic Kidney Disease: a randomised controlled trial

    PubMed Central

    2009-01-01

    Background Approximately 50% of patients with stage 3 Chronic Kidney Disease are 25-hydroxyvitamin D insufficient, and this prevalence increases with falling glomerular filtration rate. Vitamin D is now recognised as having pleiotropic roles beyond bone and mineral homeostasis, with the vitamin D receptor and metabolising machinery identified in multiple tissues. Worryingly, recent observational data has highlighted an association between hypovitaminosis D and increased cardiovascular mortality, possibly mediated via vitamin D effects on insulin resistance and inflammation. The main hypothesis of this study is that oral Vitamin D supplementation will ameliorate insulin resistance in patients with Chronic Kidney Disease stage 3 when compared to placebo. Secondary hypotheses will test whether this is associated with decreased inflammation and bone/adipocyte-endocrine dysregulation. Methods/Design This study is a single-centre, double-blinded, randomised, placebo-controlled trial. Inclusion criteria include; estimated glomerular filtration rate 30-59 ml/min/1.73 m2; aged ≥18 on entry to study; and serum 25-hydroxyvitamin D levels <75 nmol/L. Patients will be randomised 1:1 to receive either oral cholecalciferol 2000IU/day or placebo for 6 months. The primary outcome will be an improvement in insulin sensitivity, measured by hyperinsulinaemic euglycaemic clamp. Secondary outcome measures will include serum parathyroid hormone, cytokines (Interleukin-1β, Interleukin-6, Tumour Necrosis Factor alpha), adiponectin (total and High Molecular Weight), osteocalcin (carboxylated and under-carboxylated), peripheral blood mononuclear cell Nuclear Factor Kappa-B p65 binding activity, brachial artery reactivity, aortic pulse wave velocity and waveform analysis, and indirect calorimetry. All outcome measures will be performed at baseline and end of study. Discussion To date, no randomised controlled trial has been performed in pre-dialysis CKD patients to study the correlation

  20. Clinical and biological aspects of rotator cuff tears

    PubMed Central

    Giai Via, Alessio; De Cupis, Mauro; Spoliti, Marco; Oliva, Francesco

    2013-01-01

    Summary Rotator cuff tears are common and are a frequent source of shoulder pain and disability. A wide variation in the prevalence of rotator cuff tears has been reported. The etiology of rotator cuff tear remains multifactorial and attempts to unify intrinsic and extrinsic theories tried to explain the etiopathogenesis of rotator cuff tears. Knowledge of the etiopathogenesis of rotator cuff tears is important to improve our therapies, surgical techniques and promote tendon repair. Several strategies have been proposed to enhance tendon healing and recently research has focused on regenerative therapies, such as Growth Factors (GFs) and Plasma Rich Platelet (PRP), with high expectations of success. PMID:23888289

  1. Arthroscopic Superior Capsule Reconstruction for Irreparable Rotator Cuff Tears.

    PubMed

    Petri, Maximilian; Greenspoon, Joshua A; Millett, Peter J

    2015-12-01

    Massive irreparable rotator cuff tears in young patients are a particular challenge for the orthopaedic surgeon. Surgical treatment options include debridement, partial rotator cuff repair, patch-augmented rotator cuff repair, bridging rotator cuff reconstruction with graft interposition, tendon transfer, and reverse total shoulder arthroplasty. Recently, reconstruction of the superior glenohumeral capsule using a fascia lata autograft has been suggested to reduce superior glenohumeral translation and restore superior stability. Promising clinical results have been reported in 1 case series of 23 patients, indicating that superior capsular reconstruction may be a promising tool to manage massive irreparable rotator cuff tears. This article describes our preferred technique for arthroscopic superior capsule reconstruction. PMID:27284506

  2. A randomised controlled trial of three pragmatic approaches to initiate increased physical activity in sedentary patients with risk factors for cardiovascular disease.

    PubMed Central

    Little, Paul; Dorward, Martina; Gralton, Sarah; Hammerton, Louise; Pillinger, John; White, Peter; Moore, Michael; McKenna, Jim; Payne, Sheila

    2004-01-01

    BACKGROUND: Physical activity is a major modifiable risk factor for cardiovascular disease, but it is unclear what combination of feasible approaches, using existing resources in primary care, work best to initiate increased physical activity. AIM: To assess three approaches to initiate increased physical activity. DESIGN OF STUDY: Randomised controlled (2 X 2 X 2) factorial trial. SETTING: Four general practices. METHOD: One hundred and fifty-one sedentary patients with computer documented risk factors for cardiovascular disease were randomised to eight groups defined by three factors: prescription by general practitioners (GPs) for brisk exercise not requiring a leisure facility (for example, walking) 30 minutes per day, 5 days per week; counselling by practice nurses, based on psychological theory to modify intentions and perceived control of behaviour, and using behavioural implementation techniques (for example, contracting, 'rehearsal'); use of the Health Education Authority booklet 'Getting active, feeling fit'. RESULTS: Single interventions had modest effects. There was a trend from the least intensive interventions (control +/- booklet) to the more intensive interventions (prescription and counselling combined +/- booklet) for both increased physical activity and fitness (test for trend, P = 0.02 and P = 0.05, respectively). Only with the most intense intervention (prescription and counselling combined) were there significant increases in both physical activity and fitness from baseline (Godin score = 14.4, 95% confidence interval [CI] = 7.8 to 21, which was equivalent to three 15-minute sessions of brisk exercise and a 6-minute walking distance = 28.5 m, respectively, 95% CI = 11.1 to 45.8). Counselling only made a difference among those individuals with lower intention at baseline. CONCLUSION: Feasible interventions using available staff, which combine exercise prescription and counselling explicitly based on psychological theory, can probably initiate

  3. Use of pentosan polysulphate in cats with idiopathic, non-obstructive lower urinary tract disease: a double-blind, randomised, placebo-controlled trial.

    PubMed

    Wallius, Barbro M; Tidholm, Anna E

    2009-06-01

    Idiopathic feline lower urinary tract disease (FLUTD) is a common clinical entity where different treatments, for example glycosaminoglycans (GAGs) such as pentosan polysulphate (PPS), are advocated. However, few treatments have been investigated by well-controlled clinical trials. This paper compares the use of PPS in FLUTD compared to placebo. Of the 18 cats in the experiment, nine were treated with PPS and nine were treated with placebo with subcutaneous injections of 3mg/kg PPS or placebo day 1, 2, 5 and 10. The study was double-blind, randomised and placebo-controlled. Revaluation was performed after 5 and 10 days, 2 weeks, 2, 6 and 12 months. There were no statistically significant differences concerning clinical signs between groups during treatment or at re-evaluation, except for pretreatment stressful events where PPS-treated cats had experienced significantly more stressful events compared to cats treated with placebo before entering the study. Six cats (33%) showed recurrence of clinical signs during the entire study period, and only one of these cats had more than one recurrent episode. One cat (placebo) was euthanased 7 days after initial treatment because of recurrence of clinical signs. Another cat (placebo) was euthanased due to other reasons after 6 months. At 2 weeks two cats (placebo and PPS) showed clinical signs. At 2 months re-evaluation one cat showed mild clinical signs. At 6 and 12 months all remaining 16 cats were healthy. Idiopathic, non-obstructive FLUTD is a self-limiting disease with good short-term and excellent long-term prognosis without treatment. Whether or not PPS may be beneficial in a subpopulation of cats with continuous or frequently recurring clinical signs may be elucidated in forthcoming double-blind, randomised and placebo-controlled trials including only this subpopulation of cats.

  4. The minimal leak test technique for endotracheal cuff maintenance.

    PubMed

    DA, Harvie; Jn, Darvall; M, Dodd; A, De La Cruz; M, Tacey; Rl, D'Costa; D, Ward

    2016-09-01

    Endotracheal tube (ETT) cuff pressure management is an essential part of airway management in intubated and mechanically ventilated patients. Both under- and over-inflation of the ETT cuff can lead to patient complications, with an ideal pressure range of 20-30 cmH2O defined. A range of techniques are employed to ensure adequate ETT cuff inflation, with little comparative data. We performed an observational cross-sectional study in a tertiary metropolitan ICU, assessing the relationship between the minimal leak test and cuff manometry. Forty-five mechanically ventilated patients, over a three-month period, had ETT cuff manometry performed at the same time as their routine cuff maintenance (minimal leak test). Bedside nurse measurements were compared with investigator measurements. At the endpoint of cuff inflation, 20 of 45 patients (44%) had cuff pressures between 20 and 30 cmH2O; 11 of 45 patients (24%) had cuff pressures <20 cmH2O; 14 of 45 patients (31%) had cuff pressures ≥30 cmH2O. Univariate analysis demonstrated an association between both patient obesity and female gender requiring less ETT cuff volume (P=0.008 and P <0.001 respectively), though this association was lost on multivariate analysis. No association was demonstrated between any measured variables and cuff pressures. Inter-operator reliability in performing the minimal leak test showed no evidence of bias between nurse and investigators (Pearson coefficient = 0.897). We conclude the minimal leak test for maintenance of ETT cuffs leads to both over- and under-inflation, and alternative techniques, such as cuff manometry, should be employed. PMID:27608343

  5. Control device for prosthetic urinary sphincter cuff

    NASA Technical Reports Server (NTRS)

    Reinicke, Robert H. (Inventor)

    1983-01-01

    A device for controlling flow of fluid to and from a resilient inflatable cuff implanted about the urethra to control flow of urine therethrough. The device comprises a flexible bulb reservoir and a control unit that includes a manually operated valve that opens automatically when the bulb is squeezed to force fluid into the cuff for closing the urethra. The control unit also includes a movable valve seat member having a relatively large area exposed to pressure of fluid in a chamber that is connected to the cuff and which moves to a position in which the valve member is unseated by an abutment when fluid pressure in the chamber exceeds a predetermined value to thereby relieve excess fluid pressure in the cuff. The arrangement is such that the valve element is held closed against the seat member by the full differential in fluid pressures acting on both sides of the valve element until the seat member is moved away from the valve element to thus insure positive closing of the valve element until the seat member is moved out of engagement with the valve element by excess pressure differential.

  6. Effects of telephone health mentoring in community-recruited chronic obstructive pulmonary disease on self-management capacity, quality of life and psychological morbidity: a randomised controlled trial

    PubMed Central

    Walters, Julia; Cameron-Tucker, Helen; Wills, Karen; Schüz, Natalie; Scott, Jenn; Robinson, Andrew; Nelson, Mark; Turner, Paul; Wood-Baker, Richard; Walters, E Haydn

    2013-01-01

    Objectives To assess benefits of telephone-delivered health mentoring in community-based chronic obstructive pulmonary disease (COPD). Design Cluster randomised controlled trial. Setting Tasmanian general practices: capital city (11), large rural (3), medium rural (1) and small rural (16). Participants Patients were invited (1207) from general practitioner (GP) databases with COPD diagnosis and/or tiotropium prescription, response rate 49% (586), refused (176) and excluded (criteria: smoking history or previous study, 68). Spirometry testing (342) confirmed moderate or severe COPD in 182 (53%) patients. Randomisation By random numbers code, block stratified on location, allocation by sequentially numbered, opaque and sealed envelopes. Intervention Health mentor (HM) group received regular calls to manage illness issues and health behaviours from trained community health nurses using negotiated goal setting: problem solving, decision-making and action planning. Control: usual care (UC) group received GP care plus non-interventional brief phone calls. Outcomes Measured at 0, 6 and 12 months, the Short Form 36 (SF-36) and St George’s Respiratory Questionnaire (SGRQ, primary); Partners In Health (PIH) Scale for self-management capacity, Hospital Anxiety and Depression Scale (HADS), Center for Epidemiologic Studies-Depression (CES-D) questionnaire, Post-Traumatic Stress Disorder Checklist, Satisfaction with life and hospital admissions (secondary). Results 182 participants with COPD (age 68±8 years, 62% moderate COPD and 53% men) were randomised (HM=90 and UC=92). Mixed model regression analysis accounting for clustering, adjusting for age, gender, smoking status and airflow limitation assessed efficacy (regression coefficient, β, reported per 6-month visit). There was no difference in quality of life between groups, but self-management capacity increased in the HM group (PIH overall 0.15, 95% CI 0.03 to 0.29; knowledge domain 0.25, 95% CI 0.00 to 0

  7. MAGnesium-oral supplementation to reduce PAin in patients with severe PERipheral arterial occlusive disease: the MAG-PAPER randomised clinical trial protocol

    PubMed Central

    Venturini, Monica Aida; Zappa, Sergio; Minelli, Cosetta; Bonardelli, Stefano; Lamberti, Laura; Bisighini, Luca; Zangrandi, Marta; Turin, Maddalena; Rizzo, Francesco; Rizzolo, Andrea; Latronico, Nicola

    2015-01-01

    Introduction Magnesium exerts analgaesic effects in several animal pain models, as well as in patients affected by acute postoperative pain and neuropathic chronic pain. There is no evidence that magnesium can modulate pain in patients with peripheral arterial occlusive disease (PAOD). We describe the protocol of a single-centre randomised double-blind clinical trial aimed at assessing the efficacy of oral magnesium supplementation in controlling severe pain in patients with advanced PAOD. Methods and analysis Adult patients affected by PAOD at stages III and IV of Lèriche-Fontaine classification, who are opioid-naïve, and who have been admitted to our Acute Pain Service for intractable pain, will be eligible. Patients will be randomised to the control group, treated with standard therapy (oxycodone and pregabalin) plus placebo for 2 weeks, or to the experimental group (standard therapy plus magnesium oxide). Patients will be evaluated on days 0, 2, 4, 6, 8, 12 and 14; the following information will being collected: daily oxycodone dose; average and maximum pain (Numerical Rating Scale); pain relief (Pain Relief Scale); characteristics of the pain (Neuropathic Pain Scale); impact of pain on the patient's daily activities (Brief Pain Inventory). The primary outcome will be oxycodone dosage needed to achieve satisfactory analgaesia on day 14. Secondary outcomes will be pain relief on day 2, time needed to achieve satisfactory analgaesia and time needed to achieve a pain reduction of 50%. A sample size calculation was performed for the primary outcome, which estimated a required sample size of 150 patients (75 per group). Ethics and dissemination Ethical approval of the study protocol has been obtained from Comitato Etico Provinciale di Brescia, Brescia, Italy. Trial results will be disseminated through scientific journal manuscripts and scientific conference presentations. Trial registration number NCT02455726. PMID:26674497

  8. A randomised study of adjuvant chemotherapy after mantle radiotherapy in supradiaphragmatic Hodgkin's disease PS IA-IIB: a report from the Manchester lymphoma group.

    PubMed

    Anderson, H; Deakin, D P; Wagstaff, J; Jones, J M; Todd, I D; Wilkinson, P M; James, R D; Steward, W P; Blackledge, G; Scarffe, J H

    1984-06-01

    One hundred and fourteen untreated patients with pathological stage (PS) IA-IIB supradiaphragmatic Hodgkin's Disease were randomised to mantle radiotherapy alone (55) or mantle radiotherapy followed by 6 courses of adjuvant chemotherapy with mustine, vinblastine, prednisolone and procarbazine- MVPP (59). Patients excluded were those outside the age range 16-65 years and those with massive mediastinal disease precluding laparotomy. Bulk disease was defined as a mass of lymph nodes measuring five centimetres or more in any axis. Mediastinal bulk was present if the ratio of the maximum width of mediastinal disease to the maximal chest diameter was more than one third. All patients achieved a complete remission. Median duration of follow-up was 62 months (range 16-97). The relapse free survival (RFS) was 81%; 69% for radiotherapy alone and 93% for adjuvant chemotherapy (P = 0.002). RFS was also shown to be adversely affected by B symptoms (P = 0.0003), bulk disease (P = 0.018), abnormal CXR (P = 0.037), and increasing stage (P = 0.039). Age, sex, histology, and number of sites involved had no significant effect upon RFS. A Cox multivariate analysis showed that only three variables had a significant adverse effect on RFS - radiotherapy alone, the presence of bulk disease, and B symptoms. The overall 5 year survival was 93% with no statistically significant difference between the two treatment groups (P = 0.54). Survival was adversely affected by three variables - B symptoms (P = 0.02), the presence of bulk disease (P = 0.002), and pathological stage (P = 0.05). High risk groups for relapse are those with bulk and B symptoms. This analysis has shown that RFS was significantly improved by adjuvant chemotherapy, but that overall survival was not.

  9. Clinical effectiveness and cost-effectiveness of physiotherapy and occupational therapy versus no therapy in mild to moderate Parkinson's disease: a large pragmatic randomised controlled trial (PD REHAB).

    PubMed Central

    Clarke, Carl E; Patel, Smitaa; Ives, Natalie; Rick, Caroline E; Woolley, Rebecca; Wheatley, Keith; Walker, Marion F; Zhu, Shihua; Kandiyali, Rebecca; Yao, Guiqing; Sackley, Catherine M

    2016-01-01

    BACKGROUND Cochrane reviews of physiotherapy (PT) and occupational therapy (OT) for Parkinson's disease found insufficient evidence of effectiveness, but previous trials were methodologically flawed with small sample size and short-term follow-up. OBJECTIVES To evaluate the clinical effectiveness and cost-effectiveness of individualised PT and OT in Parkinson's disease. DESIGN Large pragmatic randomised controlled trial. SETTING Thirty-eight neurology and geriatric medicine outpatient clinics in the UK. PARTICIPANTS Seven hundred and sixty-two patients with mild to moderate Parkinson's disease reporting limitations in activities of daily living (ADL). INTERVENTION Patients were randomised online to either both PT and OT NHS services (n = 381) or no therapy (n = 381). Therapy incorporated a patient-centred approach with individual assessment and goal setting. MAIN OUTCOME MEASURES The primary outcome was instrumental ADL measured by the patient-completed Nottingham Extended Activities of Daily Living (NEADL) scale at 3 months after randomisation. Secondary outcomes were health-related quality of life [Parkinson's Disease Questionnaire-39 (PDQ-39); European Quality of Life-5 Dimensions (EQ-5D)], adverse events, resource use and carer quality of life (Short Form questionnaire-12 items). Outcomes were assessed before randomisation and at 3, 9 and 15 months after randomisation. RESULTS Data from 92% of the participants in each group were available at the primary time point of 3 months, but there was no difference in NEADL total score [difference 0.5 points, 95% confidence interval (CI) -0.7 to 1.7; p = 0.4] or PDQ-39 summary index (0.007 points, 95% CI -1.5 to 1.5; p = 1.0) between groups. The EQ-5D quotient was of borderline significance in favour of therapy (-0.03, 95% CI -0.07 to -0.002; p = 0.04). Contact time with therapists was for a median of four visits of 58 minutes each over 8 weeks (mean dose 232 minutes). Repeated measures analysis

  10. Tissue discrimination in magnetic resonance imaging of the rotator cuff

    NASA Astrophysics Data System (ADS)

    Meschino, G. J.; Comas, D. S.; González, M. A.; Capiel, C.; Ballarin, V. L.

    2016-04-01

    Evaluation and diagnosis of diseases of the muscles within the rotator cuff can be done using different modalities, being the Magnetic Resonance the method more widely used. There are criteria to evaluate the degree of fat infiltration and muscle atrophy, but these have low accuracy and show great variability inter and intra observer. In this paper, an analysis of the texture features of the rotator cuff muscles is performed to classify them and other tissues. A general supervised classification approach was used, combining forward-search as feature selection method with kNN as classification rule. Sections of Magnetic Resonance Images of the tissues of interest were selected by specialist doctors and they were considered as Gold Standard. Accuracies obtained were of 93% for T1-weighted images and 92% for T2-weighted images. As an immediate future work, the combination of both sequences of images will be considered, expecting to improve the results, as well as the use of other sequences of Magnetic Resonance Images. This work represents an initial point for the classification and quantification of fat infiltration and muscle atrophy degree. From this initial point, it is expected to make an accurate and objective system which will result in benefits for future research and for patients’ health.

  11. Interrater reproducibility of clinical tests for rotator cuff lesions

    PubMed Central

    Ostor, A; Richards, C; Prevost, A; Hazleman, B; Speed, C

    2004-01-01

    Background: Rotator cuff lesions are common in the community but reproducibility of tests for shoulder assessment has not been adequately appraised and there is no uniform approach to their use. Objective: To study interrater reproducibility of standard tests for shoulder evaluation among a rheumatology specialist, rheumatology trainee, and research nurse. Methods: 136 patients were reviewed over 12 months at a major teaching hospital. The three assessors examined each patient in random order and were unaware of each other's evaluation. Each shoulder was examined in a standard manner by recognised tests for specific lesions and a diagnostic algorithm was used. Between-observer agreement was determined by calculating Cohen's κ coefficients (measuring agreement beyond that expected by chance). Results: Fair to substantial agreement was obtained for the observations of tenderness, painful arc, and external rotation. Tests for supraspinatus and subscapularis also showed at least fair agreement between observers. 40/55 (73%) κ coefficient assessments were rated at >0.2, indicating at least fair concordance between observers; 21/55 (38%) were rated at >0.4, indicating at least moderate concordance between observers. Conclusion: The reproducibility of certain tests, employed by observers of varying experience, in the assessment of the rotator cuff and general shoulder disease was determined. This has implications for delegation of shoulder assessment to nurse specialists, the development of a simplified evaluation schedule for general practitioners, and uniformity in epidemiological research studies. PMID:15361389

  12. Symptoms of Pain Do Not Correlate with Rotator Cuff Tear Severity

    PubMed Central

    Dunn, Warren R.; Kuhn, John E.; Sanders, Rosemary; An, Qi; Baumgarten, Keith M.; Bishop, Julie Y.; Brophy, Robert H.; Carey, James L.; Holloway, G. Brian; Jones, Grant L.; Ma, C. Benjamin; Marx, Robert G.; McCarty, Eric C.; Poddar, Sourav K.; Smith, Matthew V.; Spencer, Edwin E.; Vidal, Armando F.; Wolf, Brian R.; Wright, Rick W.

    2014-01-01

    Background: For many orthopaedic disorders, symptoms correlate with disease severity. The objective of this study was to determine if pain level is related to the severity of rotator cuff disorders. Methods: A cohort of 393 subjects with an atraumatic symptomatic full-thickness rotator-cuff tear treated with physical therapy was studied. Baseline pretreatment data were used to examine the relationship between the severity of rotator cuff disease and pain. Disease severity was determined by evaluating tear size, retraction, superior humeral head migration, and rotator cuff muscle atrophy. Pain was measured on the 10-point visual analog scale (VAS) in the patient-reported American Shoulder and Elbow Surgeons (ASES) score. A linear multiple regression model was constructed with use of the continuous VAS score as the dependent variable and measures of rotator cuff tear severity and other nonanatomic patient factors as the independent variables. Forty-eight percent of the patients were female, and the median age was sixty-one years. The dominant shoulder was involved in 69% of the patients. The duration of symptoms was less than one month for 8% of the patients, one to three months for 22%, four to six months for 20%, seven to twelve months for 15%, and more than a year for 36%. The tear involved only the supraspinatus in 72% of the patients; the supraspinatus and infraspinatus, with or without the teres minor, in 21%; and only the subscapularis in 7%. Humeral head migration was noted in 16%. Tendon retraction was minimal in 48%, midhumeral in 34%, glenohumeral in 13%, and to the glenoid in 5%. The median baseline VAS pain score was 4.4. Results: Multivariable modeling, controlling for other baseline factors, identified increased comorbidities (p = 0.002), lower education level (p = 0.004), and race (p = 0.041) as the only significant factors associated with pain on presentation. No measure of rotator cuff tear severity correlated with pain (p > 0.25). Conclusions

  13. Effectiveness of disease-specific cognitive–behavioural therapy on depression, anxiety, quality of life and the clinical course of disease in adolescents with inflammatory bowel disease: study protocol of a multicentre randomised controlled trial (HAPPY-IBD)

    PubMed Central

    van den Brink, Gertrude; Stapersma, Luuk; El Marroun, Hanan; Henrichs, Jens; Szigethy, Eva M; Utens, Elisabeth MWJ; Escher, Johanna C

    2016-01-01

    Introduction Adolescents with inflammatory bowel disease (IBD) show a higher prevalence of depression and anxiety, compared to youth with other chronic diseases. The inflammation-depression hypothesis might explain this association, and implies that treating depression can decrease intestinal inflammation and improve disease course. The present multicentre randomised controlled trial aims to test the effectiveness of an IBD-specific cognitive–behavioural therapy (CBT) protocol in reducing symptoms of subclinical depression and anxiety, while improving quality of life and disease course in adolescents with IBD. Methods and analysis Adolescents with IBD (10–20 years) from 7 hospitals undergo screening (online questionnaires) for symptoms of depression and anxiety. Those with elevated scores of depression (Child Depression Inventory (CDI) ≥13 or Beck Depression Inventory (BDI) II ≥14) and/or anxiety (Screen for Child Anxiety Related Disorders: boys ≥26, girls ≥30) receive a psychiatric interview. Patients meeting criteria for depressive/anxiety disorders are referred for psychotherapy outside the trial. Patients with elevated (subclinical) symptoms are randomly assigned to medical care-as-usual (CAU; n=50) or CAU plus IBD-specific CBT (n=50). Main outcomes: (1) reduction in depressive and/or anxiety symptoms after 3 months and (2) sustained remission for 12 months. Secondary outcomes: quality of life, psychosocial functioning, treatment adherence. In addition, we will assess inflammatory cytokines in peripheral blood mononuclear cells and whole blood RNA expression profiles. For analysis, multilevel linear models and generalised estimating equations will be used. Ethics and dissemination The Medical Ethics Committee of the Erasmus MC approved this study. If we prove that this CBT improves emotional well-being as well as disease course, implementation is recommended. Trial registration number NCT02265588. PMID:26966551

  14. The effects of a mindfulness-based lifestyle programme for adults with Parkinson’s disease: protocol for a mixed methods, randomised two-group control study

    PubMed Central

    Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

    2013-01-01

    Introduction Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. Methods A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Analysis Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. Ethics This protocol has received ethics approval from the Monash University Human Research Ethics

  15. Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer’s disease patients’ quality of life

    PubMed Central

    2014-01-01

    Introduction Therapeutic education is expanding in the management of Alzheimer’s disease (AD) patients. Several studies have revealed a positive impact of therapeutic educational programmes on the caregiver’s burden and/or quality of life. However, to date, no study has evaluated its impact on the quality of life of the AD patient. Methods The THERAD study (THerapeutic Education in Alzheimer’s Disease) is a 12-month randomised controlled trial that started in January 2013. This paper describes the study protocol. THERAD plans to enroll 170 dyads (AD patient and caregiver) on the basis of the following criteria: patient at a mild to moderately severe stage of AD, living at home, receiving support from a family caregiver. The main outcome is the patient’s quality of life assessed by the Logsdon QoL-AD scale at 2 months, reported by the caregiver. The study is being led by geriatricians trained in therapeutic education at Toulouse University Hospital in France. To date, 107 caregiver/patient dyads have been recruited. Conclusion This is the first trial designed to assess the specific impact of a therapeutic educational programme on the AD patient’s quality of life. The final results will be available in 2015. Trial registration [ClinicalTrials.gov: NCT01796314] Registered 19 February 2013 PMID:25478028

  16. Arthroscopic Debridement for Irreparable Rotator Cuff Tears

    PubMed Central

    Hawi, N.; Schmiddem, U.; Omar, M.; Stuebig, T.; Krettek, C.; Petri, M.; Meller, R.

    2016-01-01

    Background: Arthroscopic debridement represents a salvage procedure for irreparable rotator cuff tears. It is important to accurately diagnose the patient for irreparable rotator cuff tears. The diagnosis and the therapeutic options must be explained to the patient. It is mandatory that the patient understands the primary goal of the arthroscopic debridement being reduction of pain, not improving strength or function. Methods: The procedure consists of 7 distinct steps to debride the soft tissues and alleviate pain. Results: Even though there is a lack of evidence that this procedure is superior to other therapeutic options, it has shown good results in patients with the main complaint of pain. Conclusion: The results reported in some studies should, however, be interpreted with caution, taking into consideration the substantial structural damage in irreparable defects.

  17. Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial

    PubMed Central

    Chiavaroli, Laura; Mirrahimi, Arash; Ireland, Christopher; Mitchell, Sandra; Sahye-Pudaruth, Sandhya; Coveney, Judy; Olowoyeye, Omodele; Maraj, Tishan; Patel, Darshna; de Souza, Russell J; Augustin, Livia S A; Bashyam, Balachandran; Blanco Mejia, Sonia; Nishi, Stephanie K; Leiter, Lawrence A; Josse, Robert G; McKeown-Eyssen, Gail; Moody, Alan R; Berger, Alan R; Kendall, Cyril W C; Sievenpiper, John L; Jenkins, David J A

    2016-01-01

    Introduction Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as well as on the association with surrogate markers of CVD beyond traditional risk factors. Recently, advances have been made in measures of subclinical arterial disease through the use of MRI, which, along with standard measures from carotid ultrasound (CUS) scanning, have been associated with CVD events. We therefore designed a randomised, controlled, clinical trial to assess whether low-GI dietary advice can significantly improve surrogate markers of CVD and long-term glycaemic control in T2DM. Methods and analysis 169 otherwise healthy individuals with T2DM were recruited to receive intensive counselling on a low-GI or high-cereal fibre diet for 3 years. To assess macrovascular disease, MRI and CUS are used, and to assess microvascular disease, retinal photography and 24-hour urinary collections are taken at baseline and years 1 and 3. Risk factors for CVD are assessed every 3 months. Ethics and dissemination The study protocol and consent form have been approved by the research ethics board of St. Michael's Hospital. If the study shows a benefit, these data will support the use of low-GI and/or high-fibre foods in the management of T2DM and its complications. Trial Registration number NCT01063374; Pre-results. PMID:27388364

  18. Consistent Prebiotic Effect on Gut Microbiota With Altered FODMAP Intake in Patients with Crohn's Disease: A Randomised, Controlled Cross-Over Trial of Well-Defined Diets

    PubMed Central

    Halmos, Emma P; Christophersen, Claus T; Bird, Anthony R; Shepherd, Susan J; Muir, Jane G; Gibson, Peter R

    2016-01-01

    Objectives: Altering FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) intake has substantial effects on gut microbiota. This study aimed to investigate effects of altering FODMAP intake on markers of colonic health in patients with Crohn's disease. Methods: After evaluation of their habitual diet, 9 patients with clinically quiescent Crohn's disease were randomised to 21 days of provided low or typical (“Australian”) FODMAP diets with ≥21-day washout in between. Five-day fecal samples were collected at the end of each diet and analyzed for calprotectin, pH, short-chain fatty acids (SCFA) and bacterial abundance. Gastrointestinal symptoms were recorded daily. Results: Eight participants collected feces and were adherent to the diets. FODMAP intake differed across the three dietary periods with lowdisease, altering dietary FODMAP intake is associated with marked changes in fecal microbiota, most consistent with a prebiotic effect of increasing FODMAPs as shown in an irritable bowel/healthy cohort. This strategy might be favorable for gut health in Crohn's disease, but at the cost of inducing symptoms. PMID:27077959

  19. Biological Augmentation of Rotator Cuff Tendon Repair

    PubMed Central

    Kovacevic, David

    2008-01-01

    A histologically normal insertion site does not regenerate following rotator cuff tendon-to-bone repair, which is likely due to abnormal or insufficient gene expression and/or cell differentiation at the repair site. Techniques to manipulate the biologic events following tendon repair may improve healing. We used a sheep infraspinatus repair model to evaluate the effect of osteoinductive growth factors and BMP-12 on tendon-to-bone healing. Magnetic resonance imaging and histology showed increased formation of new bone and fibrocartilage at the healing tendon attachment site in the treated animals, and biomechanical testing showed improved load-to-failure. Other techniques with potential to augment repair site biology include use of platelets isolated from autologous blood to deliver growth factors to a tendon repair site. Modalities that improve local vascularity, such as pulsed ultrasound, have the potential to augment rotator cuff healing. Important information about the biology of tendon healing can also be gained from studies of substances that inhibit healing, such as nicotine and antiinflammatory medications. Future approaches may include the use of stem cells and transcription factors to induce formation of the native tendon-bone insertion site after rotator cuff repair surgery. PMID:18264850

  20. Glenohumeral interposition of rotator cuff stumps: a rare complication of traumatic rotator cuff tear*

    PubMed Central

    Agnollitto, Paulo Moraes; Chu, Marcio Wen King; Lorenzato, Mario Muller; Zatiti, Salomão Chade Assan; Nogueira-Barbosa, Marcello Henrique

    2016-01-01

    The present report describes a case where typical findings of traumatic glenohumeral interposition of rotator cuff stumps were surgically confirmed. This condition is a rare complication of shoulder trauma. Generally, it occurs in high-energy trauma, frequently in association with glenohumeral joint dislocation. Radiography demonstrated increased joint space, internal rotation of the humerus and coracoid process fracture. In addition to the mentioned findings, magnetic resonance imaging showed massive rotator cuff tear with interposition of the supraspinatus, infraspinatus and subscapularis stumps within the glenohumeral joint. Surgical treatment was performed confirming the injury and the rotator cuff stumps interposition. It is important that radiologists and orthopedic surgeons become familiar with this entity which, because of its rarity, might be neglected in cases of shoulder trauma. PMID:26929462

  1. Assessment and treatment strategies for rotator cuff tears

    PubMed Central

    Al-Hakim, Wisam; Noorani, Ali

    2014-01-01

    Tears of the rotator cuff are common and becoming an increasingly frequent problem. There is a vast amount of literature on the merits and limitations of the various methods of clinical and radiological assessment of rotator cuff tears. This is also the case with regard to treatment strategies. Certain popular beliefs and principles practiced widely and the basis upon which they are derived may be prone to inaccuracy. We provide an overview of the historical management of rotator cuff tears, as well as an explanation for how and why rotator cuff tears should be managed, and propose a structured methodology for their assessment and treatment. PMID:27582960

  2. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs.

    PubMed Central

    Seegobin, R D; van Hasselt, G L

    1984-01-01

    Large volume, low pressure endotracheal tube cuffs are claimed to have less deleterious effect on tracheal mucosa than high pressure, low volume cuffs. Low pressure cuffs, however, may easily be overinflated to yield pressures that will exceed capillary perfusion pressure. Various large volume cuffed endotracheal tubes were studied, including Portex Profile, Searle Sensiv, Mallinkrodt Hi-Lo, and Lanz. Tracheal mucosal blood flow in 40 patients undergoing surgery was assessed using an endoscopic photographic technique while varying the cuff inflation pressure. It was found that these cuffs when overpressurised impaired mucosal blood flow. This impairment of tracheal mucosal blood flow is an important factor in tracheal morbidity associated with intubation. Hence it is recommended that a cuff inflation pressure of 30 cm H2O (22 mm Hg) should not be exceeded. Images FIG 2 FIG 3 FIG 4 PMID:6423162

  3. Ascorbic acid in Charcot–Marie–Tooth disease type 1A (CMT-TRIAAL and CMT-TRAUK): a double-blind randomised trial

    PubMed Central

    Pareyson, Davide; Reilly, Mary M; Schenone, Angelo; Fabrizi, Gian Maria; Cavallaro, Tiziana; Santoro, Lucio; Vita, Giuseppe; Quattrone, Aldo; Padua, Luca; Gemignani, Franco; Visioli, Francesco; Laurà, Matilde; Radice, Davide; Calabrese, Daniela; Hughes, Richard AC; Solari, Alessandra

    2011-01-01

    Summary Background Ascorbic acid reduced the severity of neuropathy in transgenic mice overexpressing peripheral myelin protein 22 (PMP22), a model of Charcot–Marie–Tooth disease type 1A (CMT1A) associated with the PMP22 duplication. However, in three 1-year trials, ascorbic acid had no benefit in human beings. We did a multicentre 2-year trial to test the efficacy and tolerability of ascorbic acid in patients with CMT1A. Methods Adult patients (aged 18–70 years) with symptomatic CMT1A were enrolled from nine centres in Italy and the UK, and were randomly assigned (1:1 ratio) to receive 1·5 g/day oral ascorbic acid or matching placebo for 24 months. The randomisation sequence was computer generated by block randomisation, stratified by centre and disease severity, and patients were allocated to treatment by telephone. The primary outcome was change in the CMT neuropathy score (CMTNS) at 24 months. Secondary outcomes were timed 10 m walk test, nine-hole peg test, overall neuropathy limitations scale, distal maximal voluntary isometric contraction, visual analogue scales for pain and fatigue, 36-item short-form questionnaire, and electrophysiological measurements. Patients, treating physicians, and physicians assessing outcome measures were masked to treatment allocation. Analysis of the primary outcome was done on all randomised patients who received at least one dose of study drug. This study is registered, numbers ISRCTN61074476 (CMT-TRAUK) and EudraCT 2006-000032-27 (CMT-TRIAAL). Findings We enrolled and randomly assigned 277 patients, of whom six (four assigned to receive ascorbic acid) withdrew consent before receiving treatment; 138 receiving ascorbic acid and 133 receiving placebo were eligible for analysis. Treatment was well tolerated: 241 of 271 patients (89% in each group) completed the study; 20 patients (nine receiving ascorbic acid) dropped out because of adverse events. Mean CMTNS at baseline with missing data imputed was 14·7 (SD 4·8) in the

  4. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson's disease (PD SURG trial): a randomised, open-label trial

    PubMed Central

    Williams, Adrian; Gill, Steven; Varma, Thelekat; Jenkinson, Crispin; Quinn, Niall; Mitchell, Rosalind; Scott, Richard; Ives, Natalie; Rick, Caroline; Daniels, Jane; Patel, Smitaa; Wheatley, Keith

    2010-01-01

    Summary Background Surgical intervention for advanced Parkinson's disease is an option if medical therapy fails to control symptoms adequately. We aimed to assess whether surgery and best medical therapy improved self-reported quality of life more than best medical therapy alone in patients with advanced Parkinson's disease. Methods The PD SURG trial is an ongoing randomised, open-label trial. At 13 neurosurgical centres in the UK, between November, 2000, and December, 2006, patients with Parkinson's disease that was not adequately controlled by medical therapy were randomly assigned by use of a computerised minimisation procedure to immediate surgery (lesioning or deep brain stimulation at the discretion of the local clinician) and best medical therapy or to best medical therapy alone. Patients were analysed in the treatment group to which they were randomised, irrespective of whether they received their allocated treatment. The primary endpoint was patient self-reported quality of life on the 39-item Parkinson's disease questionnaire (PDQ-39). Changes between baseline and 1 year were compared by use of t tests. This trial is registered with Current Controlled Trials, number ISRCTN34111222. Findings 366 patients were randomly assigned to receive immediate surgery and best medical therapy (183) or best medical therapy alone (183). All patients who had surgery had deep brain stimulation. At 1 year, the mean improvement in PDQ-39 summary index score compared with baseline was 5·0 points in the surgery group and 0·3 points in the medical therapy group (difference −4·7, 95% CI −7·6 to −1·8; p=0·001); the difference in mean change in PDQ-39 score in the mobility domain between the surgery group and the best medical therapy group was −8·9 (95% CI −13·8 to −4·0; p=0·0004), in the activities of daily living domain was −12·4 (−17·3 to −7·5; p<0·0001), and in the bodily discomfort domain was −7·5 (−12·6 to −2·4; p=0·004). Differences

  5. Long-term benefits of radon spa therapy in rheumatic diseases: results of the randomised, multi-centre IMuRa trial.

    PubMed

    Annegret, Franke; Thomas, Franke

    2013-11-01

    In chronic rheumatic diseases, recent treatment regimens comprise multimodal concepts including pharmacologic, physical/exercise, occupational and psychological therapies. Rehabilitation programmes are used for long-term management of disease. Spa therapy is often integrated in various middle and south European and Asian countries. Here, we investigated radon spa therapy as applied in health resorts compared to a control intervention in rheumatic out-patients. Randomised, blinded trial enroling 681 patients [mean age 58.3 (standard deviation 11.1); female 59.7%] in 7 health resorts in Germany and Austria with chronic back pain (n 1 = 437), osteoarthritis (OA) (n 2 = 230), rheumatoid arthritis (n 3 = 98), and/or ankylosing spondylitis (n 4 = 39); multiple nominations in 146 cases). Outcomes were pain (primary), quality of life, functional capacity, and medication measured before start, after end of treatment, and 3 times thereafter in 3 monthly intervals. Adverse events were documented. To analyse between-group differences, repeated-measures analysis of covariance was performed in metric endpoints and Fisher's exact test in rates. Two-sided significance level of 5% was chosen. Until end of follow-up, superiority of radon therapy was found regarding pain relief (p = 0.032) and analgesic drug consumption (p = 0.007), but not regarding quality of life. Functional capacity was assessed specific to the underlying indication. Significant benefits were found in radon-treated OA patients until 6-month follow-up (p = 0.05), but not until end of study (p = 0.096). Neither the back pain sub-population nor the two smaller patient populations with inflammatory indications benefited significantly in functional capacity. Results suggest beneficial analgesic effects of radon spa therapy in rheumatic diseases until 9 months post-intervention.

  6. Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: a prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation.

    PubMed

    Johnsen, L G; Brinckmann, P; Hellum, C; Rossvoll, I; Leivseth, G

    2013-01-01

    This prospective multicentre study was undertaken to determine segmental movement, disc height and sagittal alignment after total disc replacement (TDR) in the lumbosacral spine and to assess the correlation of biomechanical properties to clinical outcomes.A total of 173 patients with degenerative disc disease and low back pain for more than one year were randomised to receive either TDR or multidisciplinary rehabilitation (MDR). Segmental movement in the sagittal plane and disc height were measured using distortion compensated roentgen analysis (DCRA) comparing radiographs in active flexion and extension. Correlation analysis between the range of movement or disc height and patient-reported outcomes was performed in both groups. After two years, no significant change in movement in the sagittal plane was found in segments with TDR or between the two treatment groups. It remained the same or increased slightly in untreated segments in the TDR group and in this group there was a significant increase in disc height in the operated segments. There was no correlation between segmental movement or disc height and patient-reported outcomes in either group.In this study, insertion of an intervertebral disc prosthesis TDR did not increase movement in the sagittal plane and segmental movement did not correlate with patient-reported outcomes. This suggests that in the lumbar spine the movement preserving properties of TDR are not major determinants of clinical outcomes.

  7. Short- and long-term effects of tactile massage on salivary cortisol concentrations in Parkinson’s disease: a randomised controlled pilot study

    PubMed Central

    2013-01-01

    Background Parkinson’s disease (PD) is a chronic neurodegenerative disorder with limited knowledge about the normal function and effects of non-pharmacological therapies on the hypothalamic-pituitary-adrenal (HPA) axis. The aim of the study was to analyse the basal diurnal and total secretion of salivary cortisol in short- and long-term aspects of tactile massage (TM). Methods Design: Prospective, Controlled and Randomised Multicentre Trial. Setting and interventions: Forty-five women and men, aged 50–79 years, were recruited. Twenty-nine of them were blindly randomised to tactile massage (TM) and 16 of them to the control group, rest to music (RTM). Ten interventions were given during 8 weeks followed by a 26 weeks of follow up. Salivary cortisol was collected at 8 am, 1 pm, 8 pm, and 8 am the next day, on five occasions. With the first and eighth interventions, it was collected immediately before and after intervention. Main outcome measures: The primary aim was to assess and compare cortisol concentrations before and immediately after intervention and also during the follow-up period. The secondary aim was to assess the impact of age, gender, body mass index (BMI), duration and severity of PD, effects of interventional time-point of the day, and levodopa doses on cortisol concentration. Results The median cortisol concentrations for all participants were 16.0, 5.8, 2.8, and 14.0 nmol/L at baseline, later reproduced four times without significant differences. Cortisol concentrations decreased significantly after TM intervention but no change in diurnal salivary cortisol pattern was found. The findings of reduced salivary cortisol concentrations immediately after the interventions are in agreement with previous studies. However, there was no significant difference between the TM and control groups. There were no significant correlations between cortisol concentrations and age, gender, BMI, time-point for intervention, time interval between anti

  8. Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease

    PubMed Central

    Lovell, Karina; Dickens, Chris; Bower, Peter; Chew-Graham, Carolyn; McElvenny, Damien; Hann, Mark; Cherrington, Andrea; Garrett, Charlotte; Gibbons, Chris J; Baguley, Clare; Roughley, Kate; Adeyemi, Isabel; Reeves, David; Waheed, Waquas; Gask, Linda

    2015-01-01

    Objective To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions. Design Cluster randomised controlled trial. Setting 36 general practices in the north west of England. Participants 387 patients with a record of diabetes or heart disease, or both, who had depressive symptoms (≥10 on patient health questionaire-9 (PHQ-9)) for at least two weeks. Mean age was 58.5 (SD 11.7). Participants reported a mean of 6.2 (SD 3.0) long term conditions other than diabetes or heart disease; 240 (62%) were men; 360 (90%) completed the trial. Interventions Collaborative care included patient preference for behavioural activation, cognitive restructuring, graded exposure, and/or lifestyle advice, management of drug treatment, and prevention of relapse. Up to eight sessions of psychological treatment were delivered by specially trained psychological wellbeing practitioners employed by Improving Access to Psychological Therapy services in the English National Health Service; integration of care was enhanced by two treatment sessions delivered jointly with the practice nurse. Usual care was standard clinical practice provided by general practitioners and practice nurses. Main outcome measures The primary outcome was reduction in symptoms of depression on the self reported symptom checklist-13 depression scale (SCL-D13) at four months after baseline assessment. Secondary outcomes included anxiety symptoms (generalised anxiety disorder 7), self management (health education impact questionnaire), disability (Sheehan disability scale), and global quality of life (WHOQOL-BREF). Results 19 general practices were randomised to collaborative care and 20 to usual care; three practices withdrew from the trial before patients were recruited. 191 patients were recruited from practices allocated to collaborative care, and 196 from practices allocated to usual care. After adjustment for baseline depression score, mean

  9. Rotator Cuff Damage: Reexamining the Causes and Treatments.

    ERIC Educational Resources Information Center

    Nash, Heyward L.

    1988-01-01

    Sports medicine specialists are beginning to reexamine the causes and treatments of rotator cuff problems, questioning the role of primary impingement in a deficient or torn cuff and trying new surgical procedures as alternatives to the traditional open acromioplasty. (Author/CB)

  10. Anti-inflammatory effect of prophylactic macrolides on children with chronic lung disease: a protocol for a double-blinded randomised controlled trial

    PubMed Central

    Mosquera, Ricardo A; Gomez-Rubio, Ana M; Harris, Tomika; Yadav, Aravind; McBeth, Katrina; Gonzales, Traci; Jon, Cindy; Stark, James; Avritscher, Elenir; Pedroza, Claudia; Smith, Keely; Colasurdo, Giuseppe; Wootton, Susan; Piedra, Pedro; Tyson, Jon E; Samuels, Cheryl

    2016-01-01

    Introduction Recent studies suggest that the high mortality rate of respiratory viral infections is a result of an overactive neutrophilic inflammatory response. Macrolides have anti-inflammatory properties, including the ability to downregulate the inflammatory cascade, attenuate excessive cytokine production in viral infections, and may reduce virus-related exacerbations. In this study, we will test the hypothesis that prophylactic macrolides will reduce the severity of respiratory viral illness in children with chronic lung disease by preventing the full activation of the inflammatory cascade. Methods and analysis A randomised double-blind placebo-controlled trial that will enrol 92 children to receive either azithromycin or placebo for a period of 3–6 months during two respiratory syncytial virus (RSV) seasons (2015–2016 and 2016–2017). We expect a reduction of at least 20% in the total number of days of unscheduled face-to-face encounters in the treatment group as compared with placebo group. Standard frequentist and Bayesian analyses will be performed using an intent-to-treat approach. Discussion We predict that the prophylactic use of azithromycin will reduce the morbidity associated with respiratory viral infections during the winter season in patients with chronic lung disease as evidenced by a reduction in the total number of days with unscheduled face-to-face provider encounters. Ethics and dissemination This research study was approved by the Institutional Review Board of the University of Texas Health Science Center in Houston on 9 October 2014. On completion, the results will be published. Trial registration number NCT02544984. PMID:27638496

  11. Trunk muscle exercises as a means of improving postural stability in people with Parkinson's disease: a protocol for a randomised controlled trial

    PubMed Central

    Hubble, Ryan P; Naughton, Geraldine A; Silburn, Peter A; Cole, Michael H

    2014-01-01

    Introduction Exercise has been shown to improve clinical measures of strength, balance and mobility, and in some cases, has improved symptoms of tremor and rigidity in people with Parkinson's disease (PD). However, to date, no research has examined whether improvements in trunk control can remedy deficits in dynamic postural stability in this population. The proposed randomised controlled trial aims to establish whether a 12-week exercise programme aimed at improving dynamic postural stability in people with PD; (1) is more effective than education; (2) is more effective when training frequency is increased; and (3) provides greater long-term benefits than education. Methods/design Forty-five community-dwelling individuals diagnosed with idiopathic PD with a falls history will be recruited. Participants will complete baseline assessments including tests of cognition, vision, disease severity, fear of falling, mobility and quality of life. Additionally, participants will complete a series of standing balance tasks to evaluate static postural stability, while dynamic postural control will be measured during walking using head and trunk-mounted three-dimensional accelerometers. Following baseline testing, participants will be randomly-assigned to one of three intervention groups, who will receive either exercise once per week, exercise 3 days/week, or education. Participants will repeat the same battery of tests conducted at baseline after the 12-week intervention and again following a further 12-week sustainability period. Discussion This study has the potential to show that low-intensity and progressive trunk exercises can provide a non-invasive and effective means for maintaining or improving postural stability for people with PD. Importantly, if the programme is noted to be effective, it could be easily performed by patients within their home environment or under the guidance of available allied health professionals. Trial registration number The protocol for

  12. Biological factors in the pathogenesis of rotator cuff tears.

    PubMed

    Maffulli, Nicola; Longo, Umile Giuseppe; Berton, Alessandra; Loppini, Mattia; Denaro, Vincenzo

    2011-09-01

    Rotator cuff tears are common, and lead to shoulder pain and functional impairment. Despite their frequency and related disability, etiology and pathogenesis are still debated. Multiple factors contribute to tears of the rotator cuff. Extrinsic factors are anatomic variables, such as acromial morphologic characteristics, os acromiale, and acromial spurs that compress the rotator cuff by bony impingement or direct pressure from the surrounding soft tissue. Intrinsic factors arise from the tendon itself, because of tensile overload, aging, microvascular supply, traumatisms, or degeneration. Little information is available from a cellular and molecular point of view. We reviewed the biological factors involved in the pathogenesis of rotator cuff tears. Understanding the mechanism of rotator cuff pathology would facilitate the rationale for therapeutic interventions, by guiding the design, selection, and implementation of treatment strategies such as biologic modulation and preventive measures.

  13. Rotator Cuff Tear Consequent to Glenohumeral Dislocation.

    PubMed

    Gilotra, Mohit N; Christian, Matthew W; Lovering, Richard M

    2016-08-01

    The patient was a 21-year-old collegiate running back who was tackled during a football game and sustained a posterior glenohumeral dislocation. He was referred to an orthopaedist and presented 3 weeks after the injury, and, following examination, further imaging was ordered by the orthopaedist due to rotator cuff weakness. Magnetic resonance imaging showed a complete tear of the supraspinatus and infraspinatus, as well as a posterior Bankart lesion, a subscapularis tear, and a dislocation of the biceps long head tendon into the reverse Hill-Sachs lesion. J Orthop Sports Phys Ther 2016;46(8):708. doi:10.2519/jospt.2016.0413. PMID:27477475

  14. Prevalence of rotator cuff tears in operative proximal humerus fractures.

    PubMed

    Choo, Andrew; Sobol, Garret; Maltenfort, Mitchell; Getz, Charles; Abboud, Joseph

    2014-11-01

    Proximal humerus fractures and rotator cuff tears have been shown to have increasing rates with advancing age, theoretically leading to significant overlap in the 2 pathologies. The goal of this study was to examine the prevalence, associated factors, and effect on treatment of rotator cuff tears in surgically treated proximal humerus fractures. A retrospective review was performed of all patients who had surgery for a proximal humerus fracture from January 2007 to June 2012 in the shoulder department of a large academic institution. Patient demographics, the presence and management of rotator cuff tears, and surgical factors were recorded. Regression analysis was performed to determine which factors were associated with rotator cuff tears. This study reviewed 349 fractures in 345 patients. Of these, 30 (8.6%) had concomitant rotator cuff tears. Those with a rotator cuff tear were older (average age, 68.7 vs 63.1 years), were more likely to have had a dislocation (40% vs 12.5%), and were more likely to have undergone subsequent arthroscopic repair or reverse total shoulder arthroplasty than those without a rotator cuff tear. Most (22 of 30) were treated with suture repair at the time of surgery, but 5 patients underwent reverse total shoulder arthroplasty based primarily on the intraoperative finding of a significant rotator cuff tear. A concomitant rotator cuff tear in association with a proximal humerus fracture is relatively common. Rotator cuff tears are associated with older patients and those with a fracture-dislocation. In rare cases, these cases may require the availability of a reverse shoulder prosthesis. PMID:25361372

  15. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care

    PubMed Central

    2013-01-01

    Background Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. Methods/Design This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0–3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI. Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the

  16. Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial)

    PubMed Central

    2013-01-01

    Background There is growing evidence that home telemonitoring can be advantageous in societies with increasing prevalence of chronic diseases. The main objective of this study is to evaluate the effect of a primary care-based telemonitoring intervention on the number and length of hospital admissions. Methods A randomised controlled trial was carried out across 20 health centres in Bilbao (Basque Country, Spain) to assess the impact of home telemonitoring on in-home chronic patients compared with standard care. The study lasted for one year. Fifty-eight in-home patients, diagnosed with heart failure (HF) and/or chronic lung disease (CLD), aged 14 or above and with two or more hospital admissions in the previous year were recruited. The intervention consisted of daily patient self-measurements of respiratory-rate, heart-rate, blood pressure, oxygen saturation, weight, body temperature and the completion of a health status questionnaire using PDAs. Alerts were generated when pre-established thresholds were crossed. The control group (CG) received usual care. The primary outcome measure was the number of hospital admissions that occurred at 12 months post-randomisation. The impact of telemonitoring on the length of hospital stay, use of other healthcare resources and mortality was also explored. Results The intervention group (IG) included 28 patients and the CG 30. Patient baseline characteristics were similar in both groups. Of the 21 intervention patients followed-up for a year, 12 had some admissions (57.1%), compared to 19 of 22 controls (86.4%), being the difference statistically significant (p = 0.033, RR 0.66; 95%CI 0.44 to 0.99). The mean hospital stay was overall 9 days (SD 4.3) in the IG versus 10.7 (SD 11.2) among controls, and for cause-specific admissions 9 (SD 4.5) vs. 11.2 (SD 11.8) days, both without statistical significance (p = 0.891 and 0.927, respectively). Four patients need to be telemonitored for a year to prevent one admission (NNT

  17. A randomised trial of the pharmacodynamic and pharmacokinetic effects of ticagrelor compared with clopidogrel in Hispanic patients with stable coronary artery disease.

    PubMed

    Price, Matthew J; Clavijo, Leonardo; Angiolillo, Dominick J; Carlson, Glenn; Caplan, Richard; Teng, Renli; Maya, Juan

    2015-01-01

    The objective was to compare the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ticagrelor with clopidogrel among subjects of Hispanic ethnicity, as the PD and PK effects of antiplatelet agents among Hispanics are not specifically known. This was a randomised, open-label, crossover PD/PK study of 40 Hispanic subjects with stable coronary artery disease (CAD). Subjects were allocated to either ticagrelor 180 mg loading dose (LD)/90 mg twice-daily maintenance dose (MD) followed by clopidogrel 600 mg LD/75 mg once-daily MD with an intervening washout period, or vice versa. The primary endpoint was on-treatment reactivity (OTR) at 2 h post-LD according to the VerifyNow P2Y12 test. OTR was significantly lower at 2 h post-LD with ticagrelor compared with clopidogrel (34 PRU vs. 201 PRU, least square means difference = -167 PRU [95 % CI, -197, -137], P < 0.001). OTR was also lower with ticagrelor at 30 min and 8 h post-LD (P < 0.001). The greater magnitude of antiplatelet effect with ticagrelor persisted after 7 days of MD (52 PRU [95 % CI, 30, 73] vs. 182 PRU [95 % CI, 160, 205], P < 0.001). Mean plasma concentration of ticagrelor and its active metabolite were greatest at 2 h post-LD, with similar levels at 2 h post-MD after 7 days of MD. Among Hispanic subjects with stable CAD, ticagrelor provides a more rapid onset of platelet inhibition and a significantly greater antiplatelet effect compared with clopidogrel during both the loading and maintenance phases of treatment. PMID:25305090

  18. Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial

    PubMed Central

    Johansson, Tim; Keller, Sophie; Winkler, Henrike; Weitgasser, Raimund; Sönnichsen, Andreas C.

    2016-01-01

    Aim. Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Methods. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. Results. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI −0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group. Conclusion. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. Trial Registration. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077). PMID:26858958

  19. A randomised trial of the pharmacodynamic and pharmacokinetic effects of ticagrelor compared with clopidogrel in Hispanic patients with stable coronary artery disease.

    PubMed

    Price, Matthew J; Clavijo, Leonardo; Angiolillo, Dominick J; Carlson, Glenn; Caplan, Richard; Teng, Renli; Maya, Juan

    2015-01-01

    The objective was to compare the pharmacodynamic (PD) and pharmacokinetic (PK) effects of ticagrelor with clopidogrel among subjects of Hispanic ethnicity, as the PD and PK effects of antiplatelet agents among Hispanics are not specifically known. This was a randomised, open-label, crossover PD/PK study of 40 Hispanic subjects with stable coronary artery disease (CAD). Subjects were allocated to either ticagrelor 180 mg loading dose (LD)/90 mg twice-daily maintenance dose (MD) followed by clopidogrel 600 mg LD/75 mg once-daily MD with an intervening washout period, or vice versa. The primary endpoint was on-treatment reactivity (OTR) at 2 h post-LD according to the VerifyNow P2Y12 test. OTR was significantly lower at 2 h post-LD with ticagrelor compared with clopidogrel (34 PRU vs. 201 PRU, least square means difference = -167 PRU [95 % CI, -197, -137], P < 0.001). OTR was also lower with ticagrelor at 30 min and 8 h post-LD (P < 0.001). The greater magnitude of antiplatelet effect with ticagrelor persisted after 7 days of MD (52 PRU [95 % CI, 30, 73] vs. 182 PRU [95 % CI, 160, 205], P < 0.001). Mean plasma concentration of ticagrelor and its active metabolite were greatest at 2 h post-LD, with similar levels at 2 h post-MD after 7 days of MD. Among Hispanic subjects with stable CAD, ticagrelor provides a more rapid onset of platelet inhibition and a significantly greater antiplatelet effect compared with clopidogrel during both the loading and maintenance phases of treatment.

  20. Study design for a randomised controlled trial to explore the modality and mechanism of Tai Chi in the pulmonary rehabilitation of chronic obstructive pulmonary disease

    PubMed Central

    Fu, Juan-Juan; Min, Jie; Yu, Peng-Ming; McDonald, Vanessa M; Mao, Bing

    2016-01-01

    Introduction Although pulmonary rehabilitation (PR) is associated with significant clinical benefits in chronic obstructive pulmonary disease (COPD) and has been recommended by guidelines, PR with conventional exercise training has not been widely applied in the clinic because of its inherent limitations. Alternative exercise such as Tai Chi has been investigated and the results are promising. However, the strengths and weaknesses of the exercise modality of Tai Chi, conventional PR and a combination of Tai Chi and conventional PR and the possible mechanisms underlying Tai Chi exercise remain unclear. This study aims to address the above research gaps in a well-designed clinical trial. Methods and analysis This study is a single-blind, randomised controlled trial. Participants with stable COPD will be recruited and randomly assigned to one of four groups receiving Tai Chi exercise, conventional PR using a total body recumbent stepper (TBRS), combined Tai Chi and TBRS, or usual care (control) in a 1:1:1:1 ratio. Participants will perform 30 min of supervised exercise three times a week for 8 weeks; they will receive sequential follow-ups until 12 months after recruitment. The primary outcome will be health-related quality of life as measured by the St George's Respiratory Questionnaire. Secondary outcomes will include 6 min walking distance, pulmonary function, the modified Medical Research Council Dyspnoea Scale, the COPD Assessment Test, the Hospital Anxiety and Depression Scale, the Berg Balance Scale, exacerbation frequency during the study period, and systemic inflammatory and immune markers. Ethics and dissemination Ethics approval has been granted by the Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University (No TCM-2015-82). Written informed consent will be obtained from each participant before any procedures are performed. The study findings will be published in peer-reviewed journals and presented at national

  1. Double-needle ultrasound-guided percutaneous treatment of rotator cuff calcific tendinitis: tips & tricks.

    PubMed

    Sconfienza, Luca Maria; Viganò, Sara; Martini, Chiara; Aliprandi, Alberto; Randelli, Pietro; Serafini, Giovanni; Sardanelli, Francesco

    2013-01-01

    Rotator cuff calcific tendinitis is a very common disease and may result in a very painful shoulder. Aetiology of this disease is still poorly understood. When symptoms are mild, this disease may be treated conservatively. Several treatment options have been proposed. Among them, ultrasound-guided procedures have been recently described. All procedures use one or two needles to inject a fluid, to dissolve calcium and to aspirate it. In the present article, we review some tips and tricks that may be useful to improve performance of an ultrasound-guided double-needle procedure.

  2. Effectiveness of the Assessment of Burden of Chronic Obstructive Pulmonary Disease (ABC) tool: study protocol of a cluster randomised trial in primary and secondary care

    PubMed Central

    2014-01-01

    Background Chronic Obstructive Pulmonary Disease (COPD) is a growing worldwide problem that imposes a great burden on the daily life of patients. Since there is no cure, the goal of treating COPD is to maintain or improve quality of life. We have developed a new tool, the Assessment of Burden of COPD (ABC) tool, to assess and visualize the integrated health status of patients with COPD, and to provide patients and healthcare providers with a treatment algorithm. This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary. The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months. Methods/Design A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands. An intervention group, receiving care based on the ABC tool, will be compared with a control group receiving usual care. The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire, the Saint George Respiratory Questionnaire. Secondary outcomes will be a different questionnaire (the COPD Assessment Test), lung function and number of exacerbations. During the 18 months follow-up, seven measurements will be conducted, including a baseline and final measurement. Patients will receive questionnaires to be completed at home. Additional data, such as number of exacerbations, will be recorded by the patients’ healthcare providers. A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists. Additionally, a process evaluation will be performed among patients and healthcare providers. Discussion The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines, which describe the necessity to classify patients on both their airway obstruction and a comprehensive

  3. Management of Rotator Cuff and Impingement Injuries in the Athlete

    PubMed Central

    Williams, Gerald R.; Kelley, Martin

    2000-01-01

    Objective: To review current concepts of the pathophysiology, diagnosis, and treatment of rotator cuff and impingement injuries in the athlete. Data Sources: The information we present was compiled from a review of classic and recently published material regarding rotator cuff and impingement injuries. These materials were identified through a search of a personal literature database compiled by the authors, as well as by selective searching of the MEDLINE. In addition, much of the information presented represents observations and opinions of the authors developed over 8 to 10 years of treating shoulder injuries in athletes. Data Synthesis: Biomechanics of the normal shoulder and pathophysiology of rotator cuff injuries in the athletic population are discussed, followed by a summary of the important diagnostic features of rotator cuff and impingement injuries. The principles of rehabilitation are extensively presented, along with indications and important technical aspects of selected surgical procedures. General principles and specific protocols of postoperative rehabilitation are also summarized. Conclusions/Recommendations: Rotator cuff and impingement injuries in the athletic population are multifactorial in etiology, exhibiting significant overlap with glenohumeral instability. Nonoperative treatment is successful in most athletic patients with rotator cuff and impingement injuries. When nonoperative treatment fails, arthroscopic surgical techniques such as rotator cuff repair and subacromial decompression may be successful in returning the athlete to competition. ImagesFigure 2.Figure 3.Figure 4.Figure 5.Figure 6.Figure 7.Figure 8.Figure 9.Figure 10.Figure 11.Figure 12.Figure 13. PMID:16558644

  4. Laryngeal Cuff Force Application Modeling During Air Medical Evacuation Simulation.

    PubMed

    Eisenbrey, David; Eisenbrey, Arthur B; Pettengill, Patrick

    2016-01-01

    Endotracheal tubes are intended to protect the airway and assist with mechanical ventilation in sedated patients. The blood vessels of the tracheal mucosa can be compressed by high tracheal tube cuff pressures (> 30 cm H2O), leading to reduced mucosal blood flow with resulting ischemia and morbidity. Previous research showed a direct correlation between aircraft pressure altitude and the pressure reading from the tracheal cuff, with resulting pressures > 80 cm H2O at 10,000 ft. Standard practice is to periodically remove air from the cuff during ascent based on assumed increased pressure on the adjacent tracheal mucosa. Using a vacuum chamber and a direct reading micropressure sensor in a 22-mm-diameter semirigid tube, we assessed the direct force applied by the tracheal cuff against the laryngeal tube analog. Standard tracheal cuffs showed direct force/pressure relationships when properly inflated to 20 cm H2O but much less than reported in the literature. Current literature reports values of 55 to 150 cm H2O at 5,000 ft, whereas we report 23 to 25 cm H2O. Our data indicate that a properly inflated cuff does not exceed the critical pressure of 30 cm H2O until the altitude exceeds 8,000 ft. Thus, the standard practice of deflating the laryngeal cuff on ascent should be reconsidered because it may be counterproductive to patient safety. PMID:27637439

  5. Magnitude of Interfractional Vaginal Cuff Movement: Implications for External Irradiation

    SciTech Connect

    Ma, Daniel J.; Michaletz-Lorenz, Martha; Goddu, S. Murty; Grigsby, Perry W.

    2012-03-15

    Purpose: To quantify the extent of interfractional vaginal cuff movement in patients receiving postoperative irradiation for cervical or endometrial cancer in the absence of bowel/bladder instruction. Methods and Materials: Eleven consecutive patients with cervical or endometrial cancer underwent placement of three gold seed fiducial markers in the vaginal cuff apex as part of standard of care before simulation. Patients subsequently underwent external irradiation and brachytherapy treatment based on institutional guidelines. Daily megavoltage CT imaging was performed during each external radiation treatment fraction. The daily positions of the vaginal apex fiducial markers were subsequently compared with the original position of the fiducial markers on the simulation CT. Composite dose-volume histograms were also created by summing daily target positions. Results: The average ({+-} standard deviation) vaginal cuff movement throughout daily pelvic external radiotherapy when referenced to the simulation position was 16.2 {+-} 8.3 mm. The maximum vaginal cuff movement for any patient during treatment was 34.5 mm. In the axial plane the mean vaginal cuff movement was 12.9 {+-} 6.7 mm. The maximum vaginal cuff axial movement was 30.7 mm. In the craniocaudal axis the mean movement was 10.3 {+-} 7.6 mm, with a maximum movement of 27.0 mm. Probability of cuff excursion outside of the clinical target volume steadily dropped as margin size increased (53%, 26%, 4.2%, and 1.4% for 1.0, 1.5, 2.0, and 2.5 cm, respectively.) However, rectal and bladder doses steadily increased with larger margin sizes. Conclusions: The magnitude of vaginal cuff movement is highly patient specific and can impact target coverage in patients without bowel/bladder instructions at simulation. The use of vaginal cuff fiducials can help identify patients at risk for target volume excursion.

  6. Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study

    PubMed Central

    Brightling, Christopher E; Bleecker, Eugene R; Panettieri, Reynold A; Bafadhel, Mona; She, Dewei; Ward, Christine K; Xu, Xiao; Birrell, Claire; van der Merwe, René

    2016-01-01

    Summary Background Chronic obstructive pulmonary disease (COPD) is associated with eosinophilic airway inflammation in 10–20% of patients. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, depletes blood and sputum eosinophils. We aimed to establish whether benralizumab reduces acute exacerbations of COPD in patients with eosinophilia and COPD. Methods We did this randomised, double-blind, placebo-controlled, phase 2a study between Nov 18, 2010, and July 13, 2013, at 26 sites in the UK, Poland, Germany, Canada, the USA, Denmark, and Spain. Adults aged 40–85 years, with moderate-to-severe COPD, at least one acute exacerbation of COPD, and a sputum eosinophil count of 3·0% or more within the previous year, were randomly assigned (1:1) via computer-generated permuted block randomisation (block size of four), with an interactive voice or web-response system, to receive placebo or 100 mg benralizumab subcutaneously, every 4 weeks (three doses), then every 8 weeks (five doses) over 48 weeks. Study site personnel included in study assessments, participants, and data analysts, were masked to treatment allocation. The primary endpoint was the annualised rate of acute exacerbations of COPD at week 56, defined as the number of acute exacerbations divided by total duration of person-year follow-up. Secondary and exploratory endpoints included COPD-specific Saint George’s Respiratory Questionnaire (SGRQ-C), Chronic Respiratory Questionnaire self-administered standardised format (CRQ-SAS), pre-bronchodilator forced expiratory volume in 1 second (FEV1), and safety. We did a prespecified subgroup analysis by baseline blood eosinophil count. Analyses were by intention to treat and per-protocol. This trial is registered with ClinicalTrials.gov, number NCT01227278. Findings We randomly assigned 101 patients to receive placebo (n=50) or benralizumab (n=51), of whom 88 (87%) patients completed the study. Six patients who completed the study were excluded from

  7. Are We Ready to Abandon Placebo in Randomised Clinical Trials for Inflammatory Bowel Disease? Pros and Cons.

    PubMed

    Danese, Silvio; Schabel, Elmer; Masure, Johan; Plevy, Scott; Schreiber, Stefan

    2016-09-01

    The role of placebo in clinical trials for drug development in inflammatory bowel disease [IBD] was the topic of a panel discussion held during the 10th Congress of the European Crohn's and Colitis Organisation [ECCO], in Barcelona, Spain, in 2015. Panellists discussed a number of issues around placebo-controlled trials in IBD, noting issues such as difficulties with recruitment, leading to less then representative patient populations in clinical studies. It was noted that, whereas the easiest answer may be to drop placebo, it is much more complicated than that. The relevance of placebo is affected by a number of factors, including the phase of the trial, as well as the nature of the drug. In most cases where placebo has been left out in drug development, it has been for trials involving a new formulation, a new dosing schedule, or a biosimilar, for example. The panel agreed that placebo-controlled trials are of particular importance early in the development programme, perhaps not so much in phase III, although placebo is important for monitoring safety. The current trial paradigm, in which patients remain on a plethora of, likely ineffective and toxic, background medication, was also questioned. The applicability of placebo in the paediatric population was also discussed. The overall consensus from this panel discussion was that placebo is still necessary in clinical trials in inflammatory bowel disease, but there remain questions as to how and when placebo should be used. PMID:27604979

  8. Rotator cuff tears: An evidence based approach

    PubMed Central

    Sambandam, Senthil Nathan; Khanna, Vishesh; Gul, Arif; Mounasamy, Varatharaj

    2015-01-01

    Lesions of the rotator cuff (RC) are a common occurrence affecting millions of people across all parts of the globe. RC tears are also rampantly prevalent with an age-dependent increase in numbers. Other associated factors include a history of trauma, limb dominance, contralateral shoulder, smoking-status, hypercholesterolemia, posture and occupational dispositions. The challenge lies in early diagnosis since a high proportion of patients are asymptomatic. Pain and decreasing shoulder power and function should alert the heedful practitioner in recognizing promptly the onset or aggravation of existing RC tears. Partial-thickness tears (PTT) can be bursal-sided or articular-sided tears. Over the course of time, PTT enlarge and propagate into full-thickness tears (FTT) and develop distinct chronic pathological changes due to muscle retraction, fatty infiltration and muscle atrophy. These lead to a reduction in tendon elasticity and viability. Eventually, the glenohumeral joint experiences a series of degenerative alterations - cuff tear arthropathy. To avert this, a vigilant clinician must utilize and corroborate clinical skill and radiological findings to identify tear progression. Modern radio-diagnostic means of ultrasonography and magnetic resonance imaging provide excellent visualization of structural details and are crucial in determining further course of action for these patients. Physical therapy along with activity modifications, anti-inflammatory and analgesic medications form the pillars of nonoperative treatment. Elderly patients with minimal functional demands can be managed conservatively and reassessed at frequent intervals. Regular monitoring helps in isolating patients who require surgical interventions. Early surgery should be considered in younger, active and symptomatic, healthy patients. In addition to being cost-effective, this helps in providing a functional shoulder with a stable cuff. An easily reproducible technique of maximal strength and

  9. Laparoscopic Transvesical Resection of an En Bloc Bladder Cuff and Distal Ureter during Nephroureterectomy

    PubMed Central

    Giannakopoulos, Stilianos; Toufas, George; Dimitriadis, Charalampos; Giannopoulos, Stavros; Kalaitzis, Christos; Bantis, Athanasios; Patris, Emmanuel; Touloupidis, Stavros

    2012-01-01

    Objective. The most appropriate technique for excising the distal ureter and bladder cuff during laparoscopic nephroureterectomy is still debated. We report our experience with a pure laparoscopic transvesical method that duplicates the long-standing open transvesical approach. Materials and Methods. Seven men and three women diagnosed with upper tract transitional cell carcinoma were treated with this procedure. Three intravesical ports were inserted, and pneumovesicum was established at 12 mmHg. Transvesical laparoscopic circumferential detachment of the bladder cuff and en bloc mobilization of the last centimeters of the distal ureter were performed, followed by the closure of the bladder defect. Subsequently, a nephrectomy was performed either laparoscopically or using an open flank approach. Results. The median age was 68.5 years. The procedure was completed uneventfully in all cases. The median operating time for distal ureter excision was 82.5 minutes (range 55–120). No complications directly related to the pneumovesicum method were recorded. The median follow-up period was 31 months (range 12–55). During the follow-up period, two patients (20%) died from the disease, and a bladder tumor developed in three cases (30%). Conclusion. The laparoscopic transvesical resection of the en bloc bladder cuff and distal ureter is a reliable, effective, and oncologically safe technique, at least in the midterm. PMID:23049475

  10. Assessment and characterization of in situ rotator cuff biomechanics

    NASA Astrophysics Data System (ADS)

    Trent, Erika A.; Bailey, Lane; Mefleh, Fuad N.; Raikar, Vipul P.; Shanley, Ellen; Thigpen, Charles A.; Dean, Delphine; Kwartowitz, David M.

    2013-03-01

    Rotator cuff disease is a degenerative disorder that is a common, costly, and often debilitating, ranging in severity from partial thickness tear, which may cause pain, to total rupture, leading to loss in function. Currently, clinical diagnosis and determination of disease extent relies primarily on subjective assessment of pain, range of motion, and possibly X-ray or ultrasound images. The final treatment plan however is at the discretion of the clinician, who often bases their decision on personal experiences, and not quantitative standards. The use of ultrasound for the assessment of tissue biomechanics is established, such as in ultrasound elastography, where soft tissue biomechanics are measured. Few studies have investigated the use of ultrasound elastography in the characterization of musculoskeletal biomechanics. To assess tissue biomechanics we have developed a device, which measures the force applied to the underlying musculotendentious tissue while simultaneously obtaining the related ultrasound images. In this work, the musculotendinous region of the infraspinatus of twenty asymptomatic male organized baseball players was examined to access the variability in tissue properties within a single patient and across a normal population. Elastic moduli at percent strains less than 15 were significantly different than those above 15 percent strain within the normal population. No significant difference in tissue properties was demonstrated within a single patient. This analysis demonstrated elastic moduli are variable across individuals and incidence. Therefore threshold elastic moduli will likely be a function of variation in local-tissue moduli as opposed to a specific global value.

  11. Patch-Augmented Rotator Cuff Repair and Superior Capsule Reconstruction

    PubMed Central

    Petri, M.; Greenspoon, J.A.; Moulton, S.G.; Millett, P.J.

    2016-01-01

    Background: Massive rotator cuff tears in active patients with minimal glenohumeral arthritis remain a particular challenge for the treating surgeon. Methods: A selective literature search was performed and personal surgical experiences are reported. Results: For patients with irreparable rotator cuff tears, a reverse shoulder arthroplasty or a tendon transfer are often performed. However, both procedures have rather high complication rates and debatable long-term results, particularly in younger patients. Therefore, patch-augmented rotator cuff repair or superior capsule reconstruction (SCR) have been recently developed as arthroscopically applicable treatment options, with promising biomechanical and early clinical results. Conclusion: For younger patients with irreparable rotator cuff tears wishing to avoid tendon transfers or reverse total shoulder arthroplasty, both patch-augmentation and SCR represent treatment options that may delay the need for more invasive surgery.

  12. Rotator Cerclage Technique for Partial Rotator Cuff Ruptures

    PubMed Central

    Bozkurt, Murat; Firat, Ahmet; Gursoy, Safa; Akkaya, Mustafa

    2015-01-01

    The frequency of partial rotator cuff tears is gradually increasing because of the advancements in imaging methods and arthroscopy techniques. One of the repair techniques is repair of the partial rotator cuff tear by conversion to a full-thickness tear. Another technique, the transtendon technique, has some practical challenges and risks. We attempted to develop a practical and easy technique with low morbidity to repair partial tears called the rotator cerclage technique. PMID:26900559

  13. Evidence for an Environmental and Inherited Predisposition Contributing to the Risk for Global Tendinopathies or Compression Neuropathies in Patients With Rotator Cuff Tears

    PubMed Central

    Tashjian, Robert Z.; Farnham, James M.; Granger, Erin K.; Teerlink, Craig C.; Cannon-Albright, Lisa A.

    2016-01-01

    Background: Rotator cuff tearing has been found to be clinically associated with other tendinopathies and compression neuropathies; a significant excess of these phenotypes has been seen in patients with rotator cuff tears. It is unclear if the association is secondary to environmental or genetic influences. Purpose: To examine population-based data for comorbid association of rotator cuff tearing and tendinopathies and compression neuropathies and to determine whether the association extends to relatives of patients with rotator cuff tears, which could suggest a genetic contribution. Study Design: Cross-sectional study; Level of evidence, 3. Methods: The Utah Population Database (UPDB) contains health and genealogical data on over 2 million Utah residents. Current Procedural Terminology, Fourth Revision, codes (CPT 4) and International Classification of Diseases, Ninth Revision, codes (ICD-9) entered in patient records were used to identify patients with rotator cuff tearing and with comorbid tendinopathies and compression neuropathies. We tested the hypothesis of excess familial clustering of these other phenotypes with rotator cuff tearing using a well-established method (estimation of relative risks) in the overall study group of rotator cuff patients (N = 1889). Results: Significantly elevated risk for elbow, hand/wrist, foot/ankle, knee, and hip tendinopathies, as well as for all tendinopathies and compression neuropathies, was observed in rotator cuff tear cases themselves (P < 2.8e–13), in their spouses (P < .02), and in their first-degree relatives (P < 5.5e–4). A significant excess of elbow (P = .01), foot/ankle (P = .04), and all tendinopathies (P = 3.1e–3) was also observed in second-degree relatives, and a significant excess of compression neuropathies (P = .03) was observed in third-degree relatives. Conclusion: The current study shows strong evidence of familial clustering of rotator cuff tearing with other tendinopathies and with compression

  14. Feasibility of a structured group education session to improve self-management of blood pressure in people with chronic kidney disease: an open randomised pilot trial

    PubMed Central

    Khunti, Kamlesh; Stone, Margaret; Farooqi, Azhar; Carr, Sue

    2011-01-01

    Objectives We aimed to test, at pilot level, a structured group educational intervention to improve self-management of blood pressure in people with chronic kidney disease (CKD). The current paper explores patient acceptability of the intervention. Design This was an open randomised pilot trial. Participants were randomly assigned to either: A control group (n=41) receiving standard clinical management of hypertension. An intervention group (n=40) receiving standard clinical care plus the educational intervention. Setting Renal outpatient clinics at a single study centre. Participants Patients with early CKD and hypertension were identified and approached for recruitment. Intervention An evidence-based structured group educational intervention (CHEERS) using the principles of social cognitive theory to improve knowledge and self-management skills. Outcomes Recruitment, uptake of the intervention and patient satisfaction were evaluated to explore patient acceptability of the intervention and to determine any differences between patients regarding recruitment and retention. Measures Data on age, sex and ethnicity were collected for all patients approached to take part. For recruited patients, data were also collected on self-efficacy (ability to self-manage). Reasons given by patients declining to take part were recorded. Patients attending the educational session also completed an evaluation form to assess satisfaction. Results A total of 267 patients were approached, and 30% were randomly assigned. Lack of time (48%) and lack of interest (44%) were the main reasons cited for non-participation in the study. Men were significantly more likely to be recruited (p=0.048). The intervention was rated enjoyable and useful by 100% of participants. However, 37.5% of the intervention group failed to attend the educational session after recruitment. Participants failing to attend were significantly more likely to be older (p=0.039) and have lower self-efficacy (p=0

  15. Feasibility of a structured group education session to improve self-management of blood pressure in people with chronic kidney disease: an open randomised pilot trial.

    PubMed

    Byrne, Jo; Khunti, Kamlesh; Stone, Margaret; Farooqi, Azhar; Carr, Sue

    2011-01-01

    Objectives We aimed to test, at pilot level, a structured group educational intervention to improve self-management of blood pressure in people with chronic kidney disease (CKD). The current paper explores patient acceptability of the intervention. Design This was an open randomised pilot trial. Participants were randomly assigned to either: A control group (n=41) receiving standard clinical management of hypertension. An intervention group (n=40) receiving standard clinical care plus the educational intervention. Setting Renal outpatient clinics at a single study centre. Participants Patients with early CKD and hypertension were identified and approached for recruitment. Intervention An evidence-based structured group educational intervention (CHEERS) using the principles of social cognitive theory to improve knowledge and self-management skills. Outcomes Recruitment, uptake of the intervention and patient satisfaction were evaluated to explore patient acceptability of the intervention and to determine any differences between patients regarding recruitment and retention. Measures Data on age, sex and ethnicity were collected for all patients approached to take part. For recruited patients, data were also collected on self-efficacy (ability to self-manage). Reasons given by patients declining to take part were recorded. Patients attending the educational session also completed an evaluation form to assess satisfaction. Results A total of 267 patients were approached, and 30% were randomly assigned. Lack of time (48%) and lack of interest (44%) were the main reasons cited for non-participation in the study. Men were significantly more likely to be recruited (p=0.048). The intervention was rated enjoyable and useful by 100% of participants. However, 37.5% of the intervention group failed to attend the educational session after recruitment. Participants failing to attend were significantly more likely to be older (p=0.039) and have lower self-efficacy (p=0

  16. No prosthetic management of massive and irreparable rotator cuff tears

    PubMed Central

    Garofalo, Raffaele; Cesari, Eugenio

    2014-01-01

    A massive rotator cuff tear is not necessarily irreparable. Number of tendons involved, muscle-tendon unit quality, and decreased acromionhumeral distance (AHD) are as important as tear size in determining reparability of lesion. Massive and irreparable rotator cuff tears cannot be anatomically repaired to the bone and are a common source of pain and disability even in middle-aged patients. In these patients when conservative management has failed, it is possible to perform different surgical techniques. A functional repair can help to restore the horizontal force couple of the cuff on the humeral head and to increase the AHD. Debridement of irreparable tears and biceps tenotomy or tenodesis can have a role in low functional demand patients but results deteriorate over time. Recently, several commercially available tissue-engineered biological and synthetic scaffolds have been developed to augment rotator cuff repairs. The aim is to provide a mechanical improvement in case of poor quality tissue at time zero and give a support to have a better cuff healing. In selected cases, the scaffold can be used also to bridge tendon defect. Patients who not have pseudoparalysis, cuff tear arthropathy and with intact deltoid function can benefit from tendon transfers with satisfactory outcomes. These different procedures should be chosen for each patient with selected criteria and after a satisfactory explanation about the really possible expectation after surgery. PMID:27582930

  17. Mechanics of the occlusive arm cuff and its application as a volume sensor.

    PubMed

    Drzewiecki, G; Bansal, V; Karam, E; Hood, R; Apple, H

    1993-07-01

    Although a common medical instrument, the mechanical function of an occlusive arm cuff has not been fully described in an engineering sense. The occlusive arm cuff is examined here using a mathematical mechanics model and experimental measurements. Cuff stretch was modeled by a nonlinear pressure-volume function. Air compression was represented by Boyle's law. An apparatus was developed to measure pressure due to the air volume pumped into the cuff for fixed arm volume. Data were obtained for two different cuff designs, and reveal a nonlinear cuff pressure-volume relationship that could be represented accurately by the mathematical model. Calibration constants are provided for the two types of occlusive cuff. Thus, the cuff pressure was found to consist of a balance between that produced by stretch of the elastic cuff bladder and that of the compression of the air contained within the bladder. The use of the gas law alone was found to be inadequate to represent the cuff mechanics. When applying the cuff to measure change in arm volume, such as during plethysmography or oscillometry, it cannot be assumed that the cuff sensitivity is constant. More precisely, it was found that the occlusive cuff is a transducer with a volume sensitivity that increases with cuff pressure and volume until it becomes nearly constant at high levels of cuff pressure (150 mmHg). A hypothetical case of a linear elastic artery with constant pulse pressure was used as input to the cuff model to illustrate the change in cuff pressure oscillations that occurs while cuff pressure is released.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:8244431

  18. Efficacy of a minimal home-based psychoeducative intervention versus usual care for managing anxiety and dyspnoea in patients with severe chronic obstructive pulmonary disease: a randomised controlled trial protocol

    PubMed Central

    Bove, Dorthe Gaby; Overgaard, Dorthe; Lomborg, Kirsten; Lindhardt, Bjarne Ørskov; Midtgaard, Julie

    2015-01-01

    Introduction In its final stages, chronic obstructive pulmonary disease is a severely disabling condition that is characterised by dyspnoea, which causes substantial anxiety. Anxiety is associated with an impaired quality of life and increased hospital admissions. Untreated comorbid anxiety can have devastating consequences for both patients and their relatives. Non-pharmacological interventions, including cognitive–behavioural therapy, have been effective in managing anxiety and dyspnoea in patients with chronic obstructive pulmonary disease. However, the majority of existing interventions have tested the efficacy of relatively intensive comprehensive programmes and primarily targeted patients who have moderate pulmonary disease. We present the rationale and design for a trial that focused on addressing the challenges experienced by severe pulmonary disease populations. The trial investigates the efficacy of a minimal home-based psychoeducative intervention versus usual care for patients with severe chronic obstructive pulmonary disease. Methods and analysis The trial is a randomised controlled trial with a 4-week and 3-month follow-up. 66 patients with severe chronic obstructive pulmonary disease and associated anxiety will be randomised 1:1 to either an intervention or control group. The intervention consists of a single psychoeducative session in the patient's home in combination with a telephone booster session. The intervention is based on a manual, with a theoretical foundation in cognitive–behavioural therapy and psychoeducation. The primary outcome is patient-reported anxiety as assessed by the Hospital and Anxiety and Depression Scale (HADS). Ethics and dissemination This trial complies with the latest Declaration of Helsinki, and The Ethics Committee of the Capital Region of Denmark (number H-1-2013-092) was queried for ethical approval. Trial results will be disseminated in peer-reviewed publications and presented at scientific conferences. Trial

  19. A three-arm phase III randomised trial assessing, in patients with extensive-disease small-cell lung cancer, accelerated chemotherapy with support of haematological growth factor or oral antibiotics

    PubMed Central

    Sculier, J P; Paesmans, M; Lecomte, J; Van Cutsem, O; Lafitte, J J; Berghmans, T; Koumakis, G; Florin, M C; Thiriaux, J; Michel, J; Giner, V; Berchier, M C; Mommen, P; Ninane, V; Klastersky, J

    2001-01-01

    The European Lung Cancer Working Party (ELCWP) designed a 3-arm phase III randomised trial to determine the role of accelerated chemotherapy in extensive-disease (ED) small-cell lung cancer (SCLC). Eligible patients were randomised between the 3 following arms: (A) Standard chemotherapy with 6 courses of EVI (epirubicin 60 mg m−2, vindesine 3 mg m−2, ifosfamide 5 g m−2; all drugs given on day 1 repeated every three weeks. (B) Accelerated chemotherapy with EVI administered every 2 weeks and GM-CSF support. (C) Accelerated chemotherapy with EVI and oral antibiotics (cotrimoxazole). Primary endpoint was survival. 233 eligible patients were randomised. Chemotherapy could be significantly accelerated in arm B with increased absolute dose-intensity. Best response rates, in the population of evaluable patients, were, respectively for arm A, B and C, 59%, 76% and 70%. The response rate was significantly higher in arm B in comparison to arm A (P = 0.04). There was, however, no survival difference with respective median duration and 2-year rate of 286 days and 5% for arm A, 264 days and 6% for arm B and 264 days and 6% for arm C. Severe thrombopenia occurred more frequently in arm B but without an increased rate of bleeding. Non-severe infections were more frequent in arm B and severe infections were less frequent in arm C. Our trial failed to demonstrate, in ED-SCLC, a survival benefit of chemotherapy acceleration by using GM-CSF support.   http://www.bjcancer.com PMID:11720426

  20. Evaluation of rotator cuff muscle strength in healthy individuals

    PubMed Central

    Cortez, Paulo José Oliveira; Tomazini, José Elias

    2015-01-01

    OBJECTIVE: To compare the strength generated by the rotator muscles of the shoulder joint between the right upper limb and left upper limb among healthy individuals. METHODS: To evaluate the muscle strength of upper limbs from isometric contractions in the horizontal direction (rotation) an isometric dynamometer was used, equipped with transducers, signal conditioning, a data acquisition board, and finally, a computer. Study participants were 22 male military subjects, aged between 18 and 19 years old, body mass between 57.7 and 93.0 kg (71.8 ± 9.45 kg) and height between 1.67 and 1.90 m (1.75 ± 0.06 m), healthy and without clinical diseases or any type of orthopedic injury in the muscle skeletal system. RESULTS: The internal rotation in the right upper limb (RUL) was higher than the average strength of internal rotation in the left upper limb (LUL) (p = 0.723). The external rotation strength in RUL was lower than the average strength of external rotation in the LUL (p=0.788). No statistical difference was observed by comparing the strength values of all isometric strength tests. CONCLUSION: For the sample and methodology used to assess muscle strength, there was no statistical difference between the strength generated by the muscles of the rotator cuff of the right and left upper limbs. Experimental Study. PMID:26207091

  1. Arthroscopic Transosseous Rotator Cuff Repair: Technical Note, Outcomes, and Complications

    PubMed Central

    Black, Eric M.; Lin, Albert; Srikumaran, Uma; Jain, Nitin; Freehill, Michael T.

    2016-01-01

    The goal of this study was to review the authors’ initial experience with arthroscopic transosseous rotator cuff repair. Thirty-one patients with full-thickness rotator cuff tears underwent arthroscopic transosseous rotator cuff repair over a 15-month period. Preoperatively, demographics and subjective scores were recorded. Postoperatively, pain levels, subjective shoulder values, satisfaction scores, American Shoulder and Elbow Surgeons (ASES) scores, complications, and reoperations were noted with a minimum 2-year follow-up. The relationships between pre- and intraoperative variables and outcome scores were determined with univariate analysis. Average patient age was 56 years, and 23 patients (74%) were men. Twenty patients (65%) underwent primary rotator cuff repair, and 11 patients (35%) underwent revision repair. Average time to follow-up was 26 months. Average preoperative pain level and subjective shoulder value were 5.1 of 10 and 35%, respectively. Average postoperative scores included pain level of 0.9 of 10, subjective shoulder value of 84%, satisfaction score of 90.6 of 100, and ASES score of 86.3 of 100. There were 3 (9.7%) major and 2 (6%) minor complications. Patients undergoing revision rotator cuff repair had significantly worse outcomes (pain level, subjective shoulder value, ASES score; P<.05) compared with those undergoing primary repair, and cortical augmentation did not significantly affect outcome. Overall, outcomes after arthroscopic transosseous rotator cuff repair are good, although patients undergoing revision repair do not have the same outcomes as those undergoing primary cuff repair. The procedure is not without complications (9.7% major, 6% minor complications). Cortical augmentation may be used to supplement fixation, although it does not necessarily affect outcomes. Patients without such augmentation may be at increased risk for suture cutout through the bone. PMID:25970360

  2. The CopenHeartSF trial—comprehensive sexual rehabilitation programme for male patients with implantable cardioverter defibrillator or ischaemic heart disease and impaired sexual function: protocol of a randomised clinical trial

    PubMed Central

    Johansen, Pernille Palm; Zwisler, Ann-Dorthe; Hastrup-Svendsen, Jesper; Frederiksen, Marianne; Lindschou, Jane; Winkel, Per; Gluud, Christian; Giraldi, Annamaria; Steinke, Elaine; Jaarsma, Tiny; Berg, Selina Kikkenborg

    2013-01-01

    Introduction Sexuality is an important part of people’s physical and mental health. Patients with heart disease often suffer from sexual dysfunction. Sexual dysfunction has a negative impact on quality of life and well-being in persons with heart disease, and sexual dysfunction is associated with anxiety and depression. Treatment and care possibilities seem to be lacking. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation possess the potential of reducing sexual dysfunction in patients with heart disease. The CopenHeartSF trial will investigate the effect of a comprehensive sexual rehabilitation programme versus usual care. Methods and analysis CopenHeartSF is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 central randomisation to sexual rehabilitation plus usual care versus usual care alone. Based on sample size calculations, 154 male patients with impaired sexual function due to implantable cardioverter defibrillator or ischaemic heart disease will be included from two university hospitals in Denmark. All patients receive usual care and patients allocated to the experimental intervention group follow a 12-week sexual rehabilitation programme consisting of an individualised exercise programme and psychoeducative consultation with a specially trained nurse. The primary outcome is sexual function measured by the International Index of Erectile Function. The secondary outcome measure is psychosocial adjustment to illness by the Psychosocial Adjustment to Illness Scale, sexual domain. A number of explorative analyses will also be conducted. Ethics and dissemination CopenHeartSF is approved by the regional ethics committee (no H-4-2012-168) and the Danish Data Protection Agency (no 2007-58-0015) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Registration Clinicaltrials.gov identifier: NCT01796353

  3. Correlations of survival with progression-free survival, response rate, and disease control rate in advanced biliary tract cancer: a meta-analysis of randomised trials of first-line chemotherapy

    PubMed Central

    Moriwaki, Toshikazu; Yamamoto, Yoshiyuki; Gosho, Masahiko; Kobayashi, Mariko; Sugaya, Akinori; Yamada, Takeshi; Endo, Shinji; Hyodo, Ichinosuke

    2016-01-01

    Background: The need to promote novel drug development for advanced biliary tract cancer (ABTC) has emphasised the importance of determining whether various efficacy end points can act as surrogates for overall survival (OS). Methods: We conducted a literature search of randomised trials of first-line chemotherapy for ABTC and investigated correlations between efficacy end points and OS using weighted linear regression analysis. The ratios of the median OS, median progression-free survival (PFS), response rate, and disease control rate in each trial were used to summarise treatment effects. The surrogate threshold effect (STE), which was the minimum treatment effect on PFS required to predict a non-zero treatment effect on OS, was calculated. Results: Seventeen randomised trials with 36 treatment arms were identified, and a sample size of 2148 patients with 19 paired arms was analysed. The strongest correlation between all evaluated efficacy end points was observed between median OS and median PFS ratios (r2=0.66). In trials with gemcitabine-containing therapies and targeted agents, the r2-values were 0.78. The STE was estimated at 0.83 for all trials and 0.81 for trials with gemcitabine-containing therapies, and was not calculated for trials with targeted agents. Conclusions: The median PFS ratio correlated well with the median OS ratio, and may be useful for planning a clinical trial for novel drug development. PMID:27031848

  4. Acellular Dermal Matrix in Rotator Cuff Surgery.

    PubMed

    Cooper, Joseph; Mirzayan, Raffy

    2016-01-01

    The success of rotator cuff repair (RCR) surgery can be measured clinically (validated outcome scores, range of motion) as well as structurally (re-tear rates using imaging studies). Regardless of repair type or technique, most studies have shown that patients do well clinically. However, multiple studies have also shown that structurally, the failure rate can be very high. A variety of factors, including poor tendon quality, age over 63 years, smoking, advanced fatty infiltration into the muscle, and the inability of the tendon to heal to bone, have been implicated as the cause of the high re-tear rate in RCRs. The suture-tendon interface is felt to be the weakest link in the RCR construct, and suture pullout through the tendon is believed to be the most common method of failure. This review of the published literature seeks to determine if there is support for augmentation of RCR with acellular dermal matrices to strengthen the suture-tendon interface and reduce the re-tear rate. PMID:27552454

  5. Rotator Cuff Tears in the Elderly Patients

    PubMed Central

    Geary, Michael B.

    2015-01-01

    Rotator cuff tears (RCT) are a common clinical problem in the geriatric population, and debate exists over how to best provide pain relief and restore shoulder function. Treatment options can be broadly divided into nonsurgical and surgical, with the majority of patients initially placed on a trial of conservative therapy. For those with irreparable RCT, low functional demand, or interest in nonoperative management, there are a number of nonsurgical treatments to consider, including rehabilitation and injections of corticosteroids, hyaluronate, and platelet-rich plasma. Surgical treatment is increasingly common, as geriatric patients remain active with high functional demands. Studies in elderly populations have demonstrated satisfactory healing and clinical results following surgical repair. Predictors of poor outcome after repair are large tear size as well as higher stages of fatty infiltration. Decompression is a less invasive surgical option that has been shown to provide short-term pain relief, though the lasting effects may deteriorate over time. A number of factors must be weighed when considering which patients are likely to benefit from surgical intervention. PMID:26328240

  6. Irreparable Rotator Cuff Tears: Restoring Joint Kinematics by Tendon Transfers

    PubMed Central

    Greenspoon, Joshua A.; Millett, Peter J.; Moulton, Samuel G.; Petri, Maximilian

    2016-01-01

    Background: Tendon transfers can be a surgical treatment option in managing younger, active patients with massive irreparable rotator cuff tears. The purpose of this article is to provide an overview of the use of tendon transfers to treat massive irreparable rotator cuff tears and to summarize clinical outcomes. Methods: A selective literature search was performed and personal surgical experiences are reported. Results: Latissimus dorsi transfers have been used for many years in the management of posterosuperior rotator cuff tears with good reported clinical outcomes. It can be transferred without or with the teres major (L’Episcopo technique). Many surgical techniques have been described for latissimus dorsi transfer including single incision, double incision, and arthroscopically assisted transfer. Transfer of the pectoralis major tendon is the most common tendon transfer procedure performed for anterosuperior rotator cuff deficiencies. Several surgical techniques have been described, however transfer of the pectoralis major beneath the coracoid process has been found to most closely replicate the force vector that is normally provided by the intact subscapularis. Conclusion: Tendon transfers can be used successfully in the management of younger patients with massive irreparable rotator cuff tears and minimal glenohumeral arthritis. Improvements in clinical outcomes scores and range of motion have been demonstrated. This can delay arthroplasty, which is of particular importance for younger patients with high functional demands.

  7. Early intervention with tiotropium in Chinese patients with GOLD stages I–II chronic obstructive pulmonary disease (Tie-COPD): study protocol for a multicentre, double-blinded, randomised, controlled trial

    PubMed Central

    Li, Xiaochen; Zhou, Yumin; Chen, Shuyun; Zheng, Jinping; Zhong, Nanshan; Ran, Pixin

    2014-01-01

    Introduction Owing to the high and increasing morbidity and mortality, chronic obstructive pulmonary disease (COPD) has become a major public health problem worldwide. Although the majority of patients with COPD are in the early stages, little attention has been paid to them, in particular regarding to early intervention. Tiotropium bromide can significantly relieve symptoms and reduce the incidence of acute exacerbations of COPD. Therefore, we hypothesise that therapy with tiotropium bromide will benefit patients with COPD with early-stage disease. Method/analysis A randomised, double-blinded, placebo-controlled, parallel-group, multicentre clinical trial (Tiotropium In Early COPD study, Tie-COPD study) is being conducted to evaluate the efficacy and safety of long-term intervention with tiotropium in patients with COPD with early-stage disease. A total of 839 patients with COPD who satisfied the eligibility criteria were randomly assigned (1:1) to receive a once daily inhaled capsule of either tiotropium bromide (18 μg) or matching placebo for 2 years. Measurements will include forced expiratory volume in 1 s, health-related quality of life, grade degree of breathlessness related to activities, COPD exacerbations and pharmacoeconomic analysis. Ethics/dissemination This study was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University. Recruitment started in November 2011 and ended in October 2013, with 839 patients randomised. The treatment follow-up of participants with Tie-COPD is currently ongoing and is due to finish in November 2015. The authors will disseminate the findings in peer-reviewed publications, conferences and seminar presentations. Trial registration ClinicalTrials.gov (NCT01455129). PMID:24549160

  8. Computerized cuff pressure algometry: A new method to assess deep-tissue hypersensitivity in fibromyalgia.

    PubMed

    Jespersen, Anders; Dreyer, Lene; Kendall, Sally; Graven-Nielsen, Thomas; Arendt-Nielsen, Lars; Bliddal, Henning; Danneskiold-Samsoe, Bente

    2007-09-01

    The aim of this study was to evaluate the use of computerized cuff pressure algometry (CPA) in fibromyalgia (FM) and to correlate deep-tissue sensitivity assessed by CPA with other disease markers of FM. Forty-eight women with FM and 16 healthy age-matched women were included. A computer-controlled, pneumatic tourniquet cuff was placed over the gastrocnemius muscle. The cuff was inflated, and the subject rated the pain intensity continuously on an electronic Visual Analogue Scale (VAS). The subject stopped the inflation at the pressure-pain tolerance and the corresponding VAS-score was determined (pressure-pain limit). The pressure at which VAS firstly exceeded 0 was defined as the pressure-pain threshold. Other disease markers (FM only): Isokinetic knee muscle strength, tenderpoint-count, myalgic score, Beck Depression Inventory, and Fibromyalgia Impact Questionnaire. Student's T-test was used to compare pressure-pain threshold and pressure-pain tolerance and the Mann-Whitney test to compare pressure-pain limit. Pearson's correlation was used to detect linear relationships. Pressure-pain threshold and pressure-pain tolerance assessed by CPA were significantly lower in FM compared to healthy controls. There was no difference in pressure-pain limit. CPA-parameters were significantly correlated to isokinetic muscle strength where more hypersensitivity resulted in lower strength. Pressure-pain threshold and pressure-pain tolerance assessed by CPA were significantly lower in patients with FM indicating muscle hyperalgesia. CPA was associated with knee muscle strength but not with measures thought to be influenced by psychological distress and mood.

  9. Comparison of prophylactic effects of polyurethane cylindrical or tapered cuff and polyvinyl chloride cuff endotracheal tubes on ventilator-associated pneumonia.

    PubMed

    Mahmoodpoor, Ata; Peyrovi-far, Ali; Hamishehkar, Hadi; Bakhtyiari, Zhaleh; Mirinezhad, Mir Mousa; Hamidi, Masoud; Golzari, Samad Eslam Jamal

    2013-08-07

    Because microaspiration of contaminated supraglottic secretions past the endotracheal tube cuff is considered to be central in the pathogenesis of pneumonia, improved design of tracheal tubes with new cuff material and shape have reduced the size and number of folds, which together with the addition of suction ports above the cuff to drain pooled subglottic secretions leads to reduced aspiration of oropharyngeal secretions. So we conducted a study to compare the prophylactic effects of polyurethane-cylindrical or tapered cuff and polyvinyl chloride cuff endotracheal tubes (ETT) on ventilator-associated pneumonia. This randomized clinical trial was carried out in a 12 bed surgical intensive care unit. 96 patients expected to require mechanical ventilation more than 96 hours were randomly allocated to one of three following groups: Polyvinyl chloride cuff (PCV) ETT, Polyurethane (PU) cylindrical Sealguard ETT and PU Taperguard ETT. Cuff pressure monitored every three hours 3 days in all patients. Mean cuff pressure didn't have significant difference between three groups during 72 hours. Pneumonia was seen in 11 patients (34%) in group PVC, 8 (25%) in Sealguard and 7 (21%) in Taperguard group. Changes in mean cuff pressure between Sealguard and PVC tubes and also between Taperguard and PVC tubes did not show any significant difference. There was no significant difference in overinflation between three groups. The use of ETT with PU material results in reducing ventilator-associated pneumonia compared to ETT with PVC cuff. In PU tubes Taperguard has less incidence of ventilator-associated pneumonia compared to Sealguard tubes.

  10. Risk Factors, Pathobiomechanics and Physical Examination of Rotator Cuff Tears

    PubMed Central

    Moulton, Samuel G.; Greenspoon, Joshua A.; Millett, Peter J.; Petri, Maximilian

    2016-01-01

    Background: It is important to appreciate the risk factors for the development of rotator cuff tears and specific physical examination maneuvers. Methods: A selective literature search was performed. Results: Numerous well-designed studies have demonstrated that common risk factors include age, occupation, and anatomic considerations such as the critical shoulder angle. Recently, research has also reported a genetic component as well. The rotator cuff axially compresses the humeral head in the glenohumeral joint and provides rotational motion and abduction. Forces are grouped into coronal and axial force couples. Rotator cuff tears are thought to occur when the force couples become imbalanced. Conclusion: Physical examination is essential to determining whether a patient has an anterosuperior or posterosuperior tear. Diagnostic accuracy increases when combining a series of examination maneuvers. PMID:27708731

  11. Effects of Wing-Cuff on NACA 23015 Aerodynamic Performances

    NASA Astrophysics Data System (ADS)

    Meftah, S. M. A.; Belhenniche, M.; Madani Fouatih, O.; Imine, B.

    2014-03-01

    The main subject of this work is the numerical study control of flow separation on a NACA 23015 airfoil by using wing cuff. This last is a leading edge modification done to the wing. The modification consists of a slight extension of the chord on the outboard section of the wings. Different numerical cases are considered for the baseline and modified airfoil NACA 23015 according at different angle of incidence. The turbulence is modeled by two equations k-epsilon model. The results of this numerical investigation showed several benefits of the wing cuff compared with a conventional airfoil and an agreement is observed between the experimental data and the present study. The most intriguing result of this research is the capability for wing cuff to perform short take-offs and landings.

  12. Calcific tendinitis of the rotator cuff

    PubMed Central

    ElShewy, Mohamed Taha

    2016-01-01

    Calcific tendinitis within the rotator cuff tendon is a common shoulder disorder that should be differentiated from dystrophic calcification as the pathogenesis and natural history of both is totally different. Calcific tendinitis usually occurs in the fifth and sixth decades of life among sedentary workers. It is classified into formative and resorptive phases. The chronic formative phase results from transient hypoxia that is commonly associated with repeated microtrauma causing calcium deposition into the matrix vesicles within the chondrocytes forming bone foci that later coalesce. This phase may extend from 1 to 6 years, and is usually asymptomatic. The resorptive phase extends from 3 wk up to 6 mo with vascularization at the periphery of the calcium deposits causing macrophage and mononuclear giant cell infiltration, together with fibroblast formation leading to an aggressive inflammatory reaction with inflammatory cell accumulation, excessive edema and rise of the intra-tendineous pressure. This results in a severely painful shoulder. Radiological investigations confirm the diagnosis and suggest the phase of the condition and are used to follow its progression. Although routine conventional X-ray allows detection of the deposits, magnetic resonance imaging studies allow better evaluation of any coexisting pathology. Various methods of treatment have been suggested. The appropriate method should be individualized for each patient. Conservative treatment includes pain killers and physiotherapy, or “minimally invasive” techniques as needling or puncture and aspiration. It is almost always successful since the natural history of the condition ends with resorption of the deposits and complete relief of pain. Due to the intolerable pain of the acute and severely painful resorptive stage, the patient often demands any sort of operative intervention. In such case arthroscopic removal is the best option as complete removal of the deposits is unnecessary. PMID

  13. Biceps Lesion Associated With Rotator Cuff Tears

    PubMed Central

    Jeong, Ho Yeon; Kim, Jung Youn; Cho, Nam Su; Rhee, Yong Girl

    2016-01-01

    Background: Various tenodesis methods are being used for long head of the biceps tendon lesions. However, there is no consensus on the most appropriate surgical method. Hypothesis: There are significant differences in incidence of cosmetic deformity and persistent bicipital pain between open subpectoral and arthroscopic intracuff tenodesis groups. Study Design: Cohort study; Level of evidence, 3. Methods: This study included 72 patients who underwent biceps tenodesis and rotator cuff repair between January 2009 and May 2014 and who were followed for at least 1 year. Open subpectoral tenodesis was performed in 39 patients (group A), and arthroscopic intracuff tenodesis was performed in 33 patients (group B). Results: In group A, the mean visual analog scale (VAS) score for pain during motion and mean University of California, Los Angeles (UCLA) and Constant scores significantly improved from 4.6, 18.6, and 64.5 preoperatively to 1.9, 30.5, and 86.5 at last follow-up, respectively (P < .001 for all). In group B, these scores significantly improved from 5.1, 17.6, and 62.9 preoperatively to 1.8, 31.5, and 85.9 at last follow-up, respectively (P < .001 for all). Popeye deformity was noted in 2 (5.2%) patients from group A and 5 (15.6%) patients from group B (P = .231). Additionally, persistent bicipital tenderness was noted in 1 (2.6%) patient from group A and 8 (24.2%) patients from group B (P = .012). Conclusion: Both open subpectoral tenodesis and arthroscopic intracuff tenodesis show good clinical outcomes for long head of the biceps tendon lesions. However, open subpectoral tenodesis may be more appropriate, considering the low incidence of Popeye deformity and tenderness. PMID:27231699

  14. [Bony avulsions of the rotator cuff : Arthroscopic concepts].

    PubMed

    Greiner, S; Scheibel, M

    2011-01-01

    Bony avulsions of the rotator cuff and isolated greater or lesser tuberosity fractures are rare injuries and a clear consensus regarding classification and therapy does not yet exist. Conservative therapy is limited, especially in injuries with displaced fragments and in these cases surgical treatment is frequently indicated. The ongoing development of arthroscopic techniques has led to quite a number of reports about arthroscopically assisted or total arthroscopic techniques in the treatment of these injuries. The advantages and disadvantages of arthroscopic concepts for the treatment of bony avulsions of the rotator cuff are presented with reference to the current literature. PMID:21153534

  15. Evaluation and nonsurgical management of rotator cuff calcific tendinopathy.

    PubMed

    Greis, Ari C; Derrington, Stephen M; McAuliffe, Matthew

    2015-04-01

    Rotator cuff calcific tendinopathy is a common finding that accounts for about 7% of patients with shoulder pain. There are numerous theories on the pathogenesis of rotator cuff calcific tendinopathy. The diagnosis is confirmed with radiography, MRI or ultrasound. There are numerous conservative treatment options available and most patients can be managed successfully without surgical intervention. Nonsteroidal anti-inflammatory drugs and multiple modalities are often used to manage pain and inflammation; physical therapy can help improve scapular mechanics and decrease dynamic impingement; ultrasound-guided needle aspiration and lavage techniques can provide long-term improvement in pain and function in these patients.

  16. The ReSPonD trial - rivastigmine to stabilise gait in Parkinson’s disease a phase II, randomised, double blind, placebo controlled trial to evaluate the effect of rivastigmine on gait in patients with Parkinson’s disease who have fallen

    PubMed Central

    2013-01-01

    Background Gait impairment is common in people with Parkinson’s disease. There is a lack of effective interventions to target this debilitating complication and therefore a need to identify new therapeutic options. An underlying cholinergic deficit contributes to both the gait and cognitive dysfunction seen in Parkinson’s disease. The combined impact of both impairments can be assessed in gait tasks performed with concomitant cognitive tasks. The aim of this trial is to evaluate the impact of a cholinesterase inhibitor on cognitive function and gait performance in people with established Parkinson’s disease. Methods/design This is a single centre, double-blind, randomised placebo-controlled trial in 130 people with Hoehn and Yahr stage 2–3 idiopathic Parkinson’s disease who have fallen in the past year. Participants will be randomised to two groups, receiving either rivastigmine capsules or identical placebo capsules for 8 months. Assessment will be undertaken at baseline and at the end of medication prescription (i.e. 8 months) with participants remaining enrolled in the trial for a further 4 months to monitor for falls and adverse events. The primary outcome is step time variability, assessed with and without the addition of concurrent cognitive tasks. Secondary outcomes will include other gait parameters, sensorimotor and balance performances, cognitive indices, falls and fall related injury, fear of falling, Parkinson’s symptoms and data pertaining to possible harms. Discussion This randomised controlled trial will examine the effect of cholinesterase inhibitor therapy on gait, balance and falls in Parkinson’s disease. If effective, it would offer a new therapeutic option to ameliorating gait and cognitive deficits in a population at high risk of falls. Trial registration ISRCTN19880883, UTN U1111-1124-0244. PMID:24299497

  17. A Prospective Evaluation of Survivorship of Asymptomatic Degenerative Rotator Cuff Tears

    PubMed Central

    Keener, Jay D.; Galatz, Leesa M.; Teefey, Sharlene A.; Middleton, William D.; Steger-May, Karen; Stobbs-Cucchi, Georgia; Patton, Rebecca; Yamaguchi, Ken

    2015-01-01

    Background: The purpose of this prospective study was to report the long-term risks of rotator cuff tear enlargement and symptom progression associated with degenerative asymptomatic tears. Methods: Subjects with an asymptomatic rotator cuff tear in one shoulder and pain due to rotator cuff disease in the contralateral shoulder enrolled as part of a prospective longitudinal study. Two hundred and twenty-four subjects (118 initial full-thickness tears, fifty-six initial partial-thickness tears, and fifty controls) were followed for a median of 5.1 years. Validated functional shoulder scores were calculated (visual analog pain scale, American Shoulder and Elbow Surgeons [ASES], and simple shoulder test [SST] scores). Subjects were followed annually with shoulder ultrasonography and clinical evaluations. Results: Tear enlargement was seen in 49% of the shoulders, and the median time to enlargement was 2.8 years. The occurrence of tear-enlargement events was influenced by the severity of the final tear type, with enlargement of 61% of the full-thickness tears, 44% of the partial-thickness tears, and 14% of the controls (p < 0.05). Subject age and sex were not related to tear enlargement. One hundred subjects (46%) developed new pain. The final tear type was associated with a greater risk of pain development, with the new pain developing in 28% of the controls, 46% of the shoulders with a partial-thickness tear, and 50% of those with a full-thickness tear (p < 0.05). The presence of tear enlargement was associated with the onset of new pain (p < 0.05). Progressive degenerative changes of the supraspinatus muscle were associated with tear enlargement, with supraspinatus muscle degeneration increasing in 4% of the shoulders with a stable tear compared with 30% of the shoulders with tear enlargement (p < 0.05). Nine percent of the shoulders with a stable tear showed increased infraspinatus muscle degeneration compared with 28% of those in which the tear had enlarged (p = 0

  18. Drinking citrus fruit juice inhibits vascular remodeling in cuff-induced vascular injury mouse model.

    PubMed

    Ohnishi, Arika; Asayama, Rie; Mogi, Masaki; Nakaoka, Hirotomo; Kan-No, Harumi; Tsukuda, Kana; Chisaka, Toshiyuki; Wang, Xiao-Li; Bai, Hui-Yu; Shan, Bao-Shuai; Kukida, Masayoshi; Iwanami, Jun; Horiuchi, Masatsugu

    2015-01-01

    Citrus fruits are thought to have inhibitory effects on oxidative stress, thereby attenuating the onset and progression of cancer and cardiovascular disease; however, there are few reports assessing their effect on vascular remodeling. Here, we investigated the effect of drinking the juice of two different citrus fruits on vascular neointima formation using a cuff-induced vascular injury mouse model. Male C57BL6 mice were divided into five groups as follows: 1) Control (water) (C), 2) 10% Citrus unshiu (CU) juice (CU10), 3) 40% CU juice (CU40), 4) 10% Citrus iyo (CI) juice (CI10), and 5) 40% CI juice (CI40). After drinking them for 2 weeks from 8 weeks of age, cuff injury was induced by polyethylene cuff placement around the femoral artery. Neointima formation was significantly attenuated in CU40, CI10 and CI40 compared with C; however, no remarkable preventive effect was observed in CU10. The increases in levels of various inflammatory markers including cytokines such as monocyte chemotactic protein-1, interleukin-6 (IL-6), IL-1β, and tumor necrosis factor-α in response to vascular injury did not differ significantly between C, CU10 and CI10. The increases in cell proliferation and superoxide anion production were markedly attenuated in CI10, but not in CU10 compared with C. The increase in phosphorylated ERK expression was markedly attenuated both in CU10 and CI10 without significant difference between CU10 and CI10. Accumulation of immune cells did not differ between CU10 and CI10. These results indicate that drinking citrus fruit juice attenuates vascular remodeling partly via a reduction of oxidative stress. Interestingly, the preventive efficacy on neointima formation was stronger in CI than in CU at least in part due to more prominent inhibitory effects on oxidative stress by CI.

  19. Drinking Citrus Fruit Juice Inhibits Vascular Remodeling in Cuff-Induced Vascular Injury Mouse Model

    PubMed Central

    Ohnishi, Arika; Asayama, Rie; Mogi, Masaki; Nakaoka, Hirotomo; Kan-no, Harumi; Tsukuda, Kana; Chisaka, Toshiyuki; Wang, Xiao-Li; Bai, Hui-Yu; Shan, Bao-Shuai; Kukida, Masayoshi; Iwanami, Jun; Horiuchi, Masatsugu

    2015-01-01

    Citrus fruits are thought to have inhibitory effects on oxidative stress, thereby attenuating the onset and progression of cancer and cardiovascular disease; however, there are few reports assessing their effect on vascular remodeling. Here, we investigated the effect of drinking the juice of two different citrus fruits on vascular neointima formation using a cuff-induced vascular injury mouse model. Male C57BL6 mice were divided into five groups as follows: 1) Control (water) (C), 2) 10% Citrus unshiu (CU) juice (CU10), 3) 40% CU juice (CU40), 4) 10% Citrus iyo (CI) juice (CI10), and 5) 40% CI juice (CI40). After drinking them for 2 weeks from 8 weeks of age, cuff injury was induced by polyethylene cuff placement around the femoral artery. Neointima formation was significantly attenuated in CU40, CI10 and CI40 compared with C; however, no remarkable preventive effect was observed in CU10. The increases in levels of various inflammatory markers including cytokines such as monocyte chemotactic protein-1, interleukin-6 (IL-6), IL-1β, and tumor necrosis factor-α in response to vascular injury did not differ significantly between C, CU10 and CI10. The increases in cell proliferation and superoxide anion production were markedly attenuated in CI10, but not in CU10 compared with C. The increase in phosphorylated ERK expression was markedly attenuated both in CU10 and CI10 without significant difference between CU10 and CI10. Accumulation of immune cells did not differ between CU10 and CI10. These results indicate that drinking citrus fruit juice attenuates vascular remodeling partly via a reduction of oxidative stress. Interestingly, the preventive efficacy on neointima formation was stronger in CI than in CU at least in part due to more prominent inhibitory effects on oxidative stress by CI. PMID:25692290

  20. Is There an Association Between the “Critical Shoulder Angle” and Clinical Outcome after Rotator Cuff Repair?

    PubMed Central

    Kirsch, Jacob Matthew; Nathani, Amit; Robbins, Christopher; Gagnier, Joel Joseph; Bedi, Asheesh; Miller, Bruce S.

    2016-01-01

    that a CSA less than 38 degrees was associated with better outcomes in patients following surgical repair of atraumatic full-thickness rotator cuff tears. This is the first study to examine the relationship between the CSA and outcomes following RCR. These findings suggest that individual scapular morphology may influence both disease development and surgical outcomes of rotator cuff tears. This association warrants further investigation.

  1. Comparison of the effects of room air and N2O + O2 used for ProSeal LMA cuff inflation on cuff pressure and oropharyngeal structure.

    PubMed

    Tekin, Murat; Kati, Ismail; Tomak, Yakup; Yuca, Koksal

    2008-01-01

    This study aimed to evaluate the effects of different inflating gases used for ProSeal LMA (PLMA) cuff inflation on cuff pressure, oropharyngeal structure, and the incidence of sore throat. Eighty patients (American Society of Anesthesiologists; ASA I-II) were randomly divided into two groups. PLMA cuff inflation was achieved with appropriate volumes of 50% N2O + 50% O2 in group I and room air in group II, respectively. When the PLMA was removed, oropharyngeal examination was carried out immediately, using a rigid optical telescope. Patients were asked about sore throat symptoms postoperatively. Cuff pressures were significantly lower in group I, except at the initial pressure measurement. Cuff pressure was positively correlated with the length of the operation in group II, and negatively correlated in group I. PLMA cuff inflation with room air led to increased cuff pressure during the operation, possibly due to the diffusion of N2O into the cuff. We consider that a PLMA cuff inflated with an N2O-O2 mixture is convenient, especially in operations in which N2O has been used.

  2. The influence of the acromial coverage index in rotator cuff tears.

    PubMed

    Torrens, Carlos; López, Joan-Miquel; Puente, Isabel; Cáceres, Enrique

    2007-01-01

    Several intrinsic and extrinsic factors have been advocated in the pathogenesis of rotator cuff tears, but it is still unclear whether the origin of the tear is related to tendon degeneration itself or induced by several morphologic changes. The purpose of this study is to determine the relationship between the acromial coverage of the humeral head and the presence of a cuff tear. We evaluated 148 shoulders, including 45 that underwent surgical rotator cuff repair (group I), 26 with documented rotator cuff tears treated conservatively (group II), and 77 with no cuff pathology as a control group (group III). The mean acromial coverage index was 0.68 in group I, 0.72 in group II, and 0.59 in group III, giving a highly significant difference (P < .0001) between the control group and both cuff tear groups. Patients with a cuff tear have a significantly higher acromial coverage index than the control group.

  3. Endotracheal tube cuff pressure before, during, and after fixed-wing air medical retrieval.

    PubMed

    Brendt, Peter; Schnekenburger, Marc; Paxton, Karen; Brown, Anthony; Mendis, Kumara

    2013-01-01

    Abstract Background. Increased endotracheal tube (ETT) cuff pressure is associated with compromised tracheal mucosal perfusion and injuries. No published data are available for Australia on pressures in the fixed-wing air medical retrieval setting. Objective. After introduction of a cuff pressure manometer (Mallinckrodt, Hennef, Germany) at the Royal Flying Doctor Service (RFDS) Base in Dubbo, New South Wales (NSW), Australia, we assessed the prevalence of increased cuff pressures before, during, and after air medical retrieval. Methods. This was a retrospective audit in 35 ventilated patients during fixed-wing retrievals by the RFDS in NSW, Australia. Explicit chart review of ventilated patients was performed for cuff pressures and changes during medical retrievals with pressurized aircrafts. Pearson correlation was calculated to determine the relation of ascent and ETT cuff pressure change from ground to flight level. Results. The mean (± standard deviation) of the first ETT cuff pressure measurement on the ground was 44 ± 20 cmH2O. Prior to retrieval in 11 patients, the ETT cuff pressure was >30 cmH2O and in 11 patients >50 cmH2O. After ascent to cruising altitude, the cuff pressure was >30 cmH2O in 22 patients and >50 cmH2O in eight patients. The cuff pressure was reduced 1) in 72% of cases prior to take off and 2) in 85% of cases during flight, and 3) after landing, the cuff pressure increased in 85% of cases. The correlation between ascent in cabin altitude and ETT cuff pressure was r = 0.3901, p = 0.0205. Conclusions. The high prevalence of excessive cuff pressures during air medical retrieval can be avoided by the use of cuff pressure manometers. Key words: cuff pressure; air medical retrieval; prehospital. PMID:23252881

  4. Endotracheal tube cuff pressure before, during, and after fixed-wing air medical retrieval.

    PubMed

    Brendt, Peter; Schnekenburger, Marc; Paxton, Karen; Brown, Anthony; Mendis, Kumara

    2013-01-01

    Abstract Background. Increased endotracheal tube (ETT) cuff pressure is associated with compromised tracheal mucosal perfusion and injuries. No published data are available for Australia on pressures in the fixed-wing air medical retrieval setting. Objective. After introduction of a cuff pressure manometer (Mallinckrodt, Hennef, Germany) at the Royal Flying Doctor Service (RFDS) Base in Dubbo, New South Wales (NSW), Australia, we assessed the prevalence of increased cuff pressures before, during, and after air medical retrieval. Methods. This was a retrospective audit in 35 ventilated patients during fixed-wing retrievals by the RFDS in NSW, Australia. Explicit chart review of ventilated patients was performed for cuff pressures and changes during medical retrievals with pressurized aircrafts. Pearson correlation was calculated to determine the relation of ascent and ETT cuff pressure change from ground to flight level. Results. The mean (± standard deviation) of the first ETT cuff pressure measurement on the ground was 44 ± 20 cmH2O. Prior to retrieval in 11 patients, the ETT cuff pressure was >30 cmH2O and in 11 patients >50 cmH2O. After ascent to cruising altitude, the cuff pressure was >30 cmH2O in 22 patients and >50 cmH2O in eight patients. The cuff pressure was reduced 1) in 72% of cases prior to take off and 2) in 85% of cases during flight, and 3) after landing, the cuff pressure increased in 85% of cases. The correlation between ascent in cabin altitude and ETT cuff pressure was r = 0.3901, p = 0.0205. Conclusions. The high prevalence of excessive cuff pressures during air medical retrieval can be avoided by the use of cuff pressure manometers. Key words: cuff pressure; air medical retrieval; prehospital.

  5. Smoking Status and a Pulmonary Function Test in Patients with Rotator Cuff Tears.

    PubMed

    Yoshii, Chiharu; Uchida, Soushi; Noguchi, Shingo; Torii, Ryo; Shimabukuro, Ikuko; Yatera, Kazuhiro

    2016-09-01

    Although chronic obstructive pulmonary disease (COPD) affects one in several smokers, only a few patients are correctly diagnosed compared to the estimated number of patients. Several recent reports indicate that the development of rotator cuff tears is related to smoking. In this study, we investigated smoking status in patients with rotator cuff tears and evaluated the possibility of undiagnosed COPD by a pulmonary function test. The subjects were 150 consecutive patients over 40 years old, who had been diagnosed with rotator cuff tears and had been examined by a pulmonary function test before surgery in our orthopedic department between April 2011 and June 2015. They consisted of 96 men and 54 women, which included 59 non-smokers (39.3%), 62 ex-smokers (41.3%), and 29 smokers (19.3%). The smoking rate of the subjects was the same as that of the general Japanese population. However, the ever-smokers who smoked more than 21 cigarettes per day were 31.9%, which was high compared to the Japanese ever-smokers population, i.e. 15.2% of men and 5.5% of women. Twenty-five subjects (16.7%) showed airflow limitation, and they consisted of 7 cases of COPD, 3 cases of bronchial asthma, one case of bronchiectasis, and 14 undiagnosed cases. The undiagnosed cases consisted of 7 non-smokers, 5 ex-smokers, and 2 smokers. Their stages of COPD were stage 1 in 11 cases and stage 2 in 3 cases. The prevalence of airflow limitation increased with increasing age: 0% for 40's, 8.3% for 50's, 20.7% for 60's, and 25.6% for over 70's. From these results, we recognized that paying attention to the numbers of cigarettes smoked per day are important in addition to the smoking history, for the patients with rotator cuff tears. Also, sharing the data of a pulmonary function test before surgery can contribute to the early diagnosis of COPD. PMID:27627973

  6. Analysis of Direct Costs of Outpatient Arthroscopic Rotator Cuff Repair.

    PubMed

    Narvy, Steven J; Ahluwalia, Avtar; Vangsness, C Thomas

    2016-01-01

    Arthroscopic rotator cuff surgery is one of the most commonly performed orthopedic surgical procedures. We conducted a study to calculate the direct cost of arthroscopic repair of rotator cuff tears confirmed by magnetic resonance imaging. Twenty-eight shoulders in 26 patients (mean age, 54.5 years) underwent primary rotator cuff repair by a single fellowship-trained arthroscopic surgeon in the outpatient surgery center of a major academic medical center. All patients had interscalene blocks placed while in the preoperative holding area. Direct costs of this cycle of care were calculated using the time-driven activity-based costing algorithm. Mean time in operating room was 148 minutes; mean time in recovery was 105 minutes. Calculated surgical cost for this process cycle was $5904.21. Among material costs, suture anchor costs were the main cost driver. Preoperative bloodwork was obtained in 23 cases, adding a mean cost of $111.04. Our findings provide important preliminary information regarding the direct economic costs of rotator cuff surgery and may be useful to hospitals and surgery centers negotiating procedural reimbursement for the increased cost of repairing complex tears. PMID:26761928

  7. Analysis of Direct Costs of Outpatient Arthroscopic Rotator Cuff Repair.

    PubMed

    Narvy, Steven J; Ahluwalia, Avtar; Vangsness, C Thomas

    2016-01-01

    Arthroscopic rotator cuff surgery is one of the most commonly performed orthopedic surgical procedures. We conducted a study to calculate the direct cost of arthroscopic repair of rotator cuff tears confirmed by magnetic resonance imaging. Twenty-eight shoulders in 26 patients (mean age, 54.5 years) underwent primary rotator cuff repair by a single fellowship-trained arthroscopic surgeon in the outpatient surgery center of a major academic medical center. All patients had interscalene blocks placed while in the preoperative holding area. Direct costs of this cycle of care were calculated using the time-driven activity-based costing algorithm. Mean time in operating room was 148 minutes; mean time in recovery was 105 minutes. Calculated surgical cost for this process cycle was $5904.21. Among material costs, suture anchor costs were the main cost driver. Preoperative bloodwork was obtained in 23 cases, adding a mean cost of $111.04. Our findings provide important preliminary information regarding the direct economic costs of rotator cuff surgery and may be useful to hospitals and surgery centers negotiating procedural reimbursement for the increased cost of repairing complex tears.

  8. Study protocol for a phase III multicentre, randomised, open-label, blinded-end point trial to evaluate the efficacy and safety of immunoglobulin plus cyclosporin A in patients with severe Kawasaki disease (KAICA Trial)

    PubMed Central

    Aoyagi, Reiko; Hamada, Hiromichi; Sato, Yasunori; Suzuki, Hiroyuki; Onouchi, Yoshihiro; Ebata, Ryota; Terauchi, Moe; Terai, Masaru; Hanaoka, Hideki; Hata, Akira

    2015-01-01

    Introduction Kawasaki disease (KD) is an acute, self-limited vasculitis of unknown aetiology that predominantly affects infants and young children. We hypothesise that cyclosporin A (CsA) may be effective in treating KD by regulating the Ca2+/NFAT signalling pathway. This trial compares the current standard therapy of intravenous immunoglobulin (IVIG) and the combined IVIG+CsA therapy in paediatric patients with severe KD. Methods and analysis This trial is a phase III, multicentre, randomised, open-label, blinded-end point trial that evaluates the efficacy and safety of IVIG+CsA therapy. Patients with severe KD who satisfy the eligibility criteria are randomised (1:1) to receive either CsA (5 mg/kg/day for 5 days; Neoral) plus high-dose IVIG (2 g/kg for 24 h and aspirin 30 mg/kg/day), or high-dose IVIG alone (2 g/kg for 24 h and aspirin 30 mg/kg/day). The primary end point is the frequency of occurrence of coronary artery abnormalities during the trial period. An independent end point review committee will be in charge of the trial assessment. Ethics and dissemination The protocol was approved by the Institutional Review Board of each institution. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, in Japan. The trial is currently on-going and is scheduled to finish in April 2017. The findings will be disseminated through peer-reviewed publications and conference presentations. Trial registration number JMA-IIA00174; Pre-results. PMID:26628527

  9. Dose-Response Evaluation of Braslet-M Occlusion Cuffs

    NASA Technical Reports Server (NTRS)

    Ebert, Douglas; Garcia, Kathleen; Sargsyan, Ashot E.; Ham, David; Hamilton, Douglas; Dulchavsky, Scott A.

    2010-01-01

    Introduction: Braslet-M is a set of special elasticized thigh cuffs used by the Russian space agency to reduce the effects of the head-ward fluid shift during early adaptation to microgravity by sequestering fluid in the lower extremities. Currently, no imaging modalities are used in the calibration of the device, and the pressure required to produce a predictable physiological response is unknown. This investigation intends to relate the pressure exerted by the cuffs to the extent of fluid redistribution and commensurate physiological effects. Materials and Methods: Ten healthy subjects with standardized fluid intake participated in the study. Data collection included femoral and internal jugular vein imaging in two orthogonal planes, pulsed Doppler of cervical and femoral vessels and middle cerebral artery, optic nerve imaging, and echocardiography. Braslet-M cuff pressure was monitored at the skin interface using pre-calibrated pressure sensors. Using 6 and 30 head-down tilt in two separate sessions, the effect of Braslet-M was assessed while incrementally tightening the cuffs. Cuffs were then simultaneously released to document the resulting hemodynamic change. Results: Preliminary analysis shows correlation between physical pressure exerted by the Braslet-M device and several parameters such as jugular and femoral vein cross-sections, resistivity of the lower extremity vascular bed, and others. A number of parameters reflect blood redistribution and will be used to determine the therapeutic range of the device and to prevent unsafe application. Conclusion: Braslet-M exerts a physical effect that can be measured and correlated with many changes in central and peripheral hemodynamics. Analysis of the full data set will be required to make definitive recommendations regarding the range of safe therapeutic application. Objective data and subjective responses suggest that a safer and equally effective use of Braslet can be achieved when compared with the current

  10. The use of mindfulness-based cognitive therapy for improving quality of life for inflammatory bowel disease patients: study protocol for a pilot randomised controlled trial with embedded process evaluation

    PubMed Central

    2013-01-01

    Background Inflammatory bowel disease (IBD) is a chronic condition with an unpredictable disease course. Rates of anxiety and depression among IBD patients in relapse (active disease symptoms) as well as in remission are higher than in the general population. Previous studies suggest that the prolonged effect of pain, anxiety, distress and depression have a detrimental effect on patients’quality of life (QoL). Poor QoL in itself is associated with further symptom relapse. Mindfulness based cognitive therapy (MBCT) is a psychological group intervention that has the potential to improve QoL. When used in other chronic conditions, it demonstrated reduced negative effect from pain and psychological factors at completion of an 8-week MBCT course. The effect of MBCT has never been researched in IBD. The aim of this study is to obtain the information required to design a full scale randomised controlled trial (RCT) that will examine the effectiveness of MBCT in improving quality of life for IBD patients. Methods/Design This is an exploratory RCT with embedded process evaluation. Forty IBD patients will be recruited from NHS outpatient gastroenterology clinics and will be randomised to either a MBCT (intervention) group or to a wait-list (control) group. All participants will undergo 16 h of structured group training over an 8-week period, with the control group starting 6 months later than the intervention group. Primary outcomes are recruitment, completion/retention rates and adherence and adaptation to the MBCT manual for IBD patients. The secondary outcome is to assess the feasibility of collecting reliable and valid data on proposed outcome measures such as quality of life, anxiety, depression, disease activity and mindful awareness. The process evaluation will use a survey and focus groups to assess the acceptability of the intervention and trial procedures for IBD patients. Discussion The outcomes of this study will help define the barriers, uptake and perceived

  11. Future Care Planning for patients approaching end-of-life with advanced heart disease: an interview study with patients, carers and healthcare professionals exploring the content, rationale and design of a randomised clinical trial

    PubMed Central

    Denvir, Martin A; Highet, Gill; Robertson, Shirley; Cudmore, Sarah; Reid, Janet; Ness, Andrea; Hogg, Karen; Weir, Christopher; Murray, Scott; Boyd, Kirsty

    2014-01-01

    Objective To explore the optimal content and design of a clinical trial of an end-of-life intervention for advanced heart disease with patients, carers and healthcare professionals. Design Qualitative interview and focus group study. Setting Community and hospital-based focus groups and interviews. Participants Stable community-dwelling patients, informal carers (PC, n=15) and primary and secondary care based healthcare professionals (HCP, n=11). Results PC highlighted fragmentation of services and difficulty in accessing specialist care as key barriers to good care. They felt that time for discussion with HCP was inadequate within current National Health Service (NHS) healthcare systems. HCP highlighted uncertainty of prognosis, explaining mortality risk to patients and switching from curative to palliative approaches as key challenges. Patient selection, nature of the intervention and relevance of trial outcomes were identified by HCP as key challenges in the design of a clinical trial. Conclusions PC and HCP expressed a number of concerns relevant to the nature and content of an end-of-life intervention for patients with advanced heart disease. The findings of this study are being used to support a phase II randomised clinical trial of Future Care Planning in advanced heart disease. PMID:25023130

  12. Retrospective study of sonographic findings in bone involvement associated with rotator cuff calcific tendinopathy: preliminary results of a case series*

    PubMed Central

    Nogueira-Barbosa, Marcello H.; Gregio-Junior, Everaldo; Lorenzato, Mario Muller

    2015-01-01

    Objective The present study was aimed at investigating bone involvement secondary to rotator cuff calcific tendonitis at ultrasonography. Materials and Methods Retrospective study of a case series. The authors reviewed shoulder ultrasonography reports of 141 patients diagnosed with rotator cuff calcific tendonitis, collected from the computer-based data records of their institution over a four-year period. Imaging findings were retrospectively and consensually analyzed by two experienced musculoskeletal radiologists looking for bone involvement associated with calcific tendonitis. Only the cases confirmed by computed tomography were considered for descriptive analysis. Results Sonographic findings of calcific tendinopathy with bone involvement were observed in 7/141 (~ 5%) patients (mean age, 50.9 years; age range, 42-58 years; 42% female). Cortical bone erosion adjacent to tendon calcification was the most common finding, observed in 7/7 cases. Signs of intraosseous migration were found in 3/7 cases, and subcortical cysts in 2/7 cases. The findings were confirmed by computed tomography. Calcifications associated with bone abnormalities showed no acoustic shadowing at ultrasonography, favoring the hypothesis of resorption phase of the disease. Conclusion Preliminary results of the present study suggest that ultrasonography can identify bone abnormalities secondary to rotator cuff calcific tendinopathy, particularly the presence of cortical bone erosion. PMID:26811551

  13. Arthroscopic Rotator Cuff Repair Using the Undersurface Technique

    PubMed Central

    Rubenis, Imants; Lam, Patrick H.; Murrell, George A.C.

    2015-01-01

    Background: Arthroscopic rotator cuff repair has traditionally been performed in the subacromial space from the bursal side of the tendon. The undersurface rotator cuff repair technique involves the arthroscope remaining in the glenohumeral joint, thus viewing the tendon from its undersurface during repair without a bursectomy or acromioplasty. Purpose: To compare the clinical and structural outcomes of undersurface rotator cuff repair with bursal-side repair. Study Design: Cohort study; Level of evidence, 3. Methods: A retrospective analysis of prospectively collected data was conducted on 2 cohorts of patients who had undergone arthroscopic rotator cuff repair with knotless suture anchors configured in a single-row formation using inverted mattress–style sutures from either the bursal side (n = 100) or undersurface (n = 165) of the supraspinatus tendon. Data were collected preoperatively, intraoperatively, and at 1 week, 6 weeks, 3 months, 6 months, and 2 years postoperatively. At each time point, patients completed a modified L’Insalata questionnaire to assess patient-ranked pain scores and were clinically examined using standardized tests. Ultrasound examination was performed at 6 months and 2 years to assess the integrity of the repair. Results: At 2 years postoperatively, patients in both cohorts had significantly less pain and less difficulty with overhead activities compared with preoperative levels (P < .001). The type of repair performed (bursal or undersurface) did not affect the ability to perform overhead activities at 2 years. At 2 years, both groups also had similar retear rates (21% for bursal side, 23% for undersurface). The mean operative time for the arthroscopic rotator cuff repair was 32 minutes when performed from the bursal side and 20 minutes when performed from the undersurface (P < .001). Conclusion: Arthroscopic rotator cuff repair, whether performed from the subacromial space or glenohumeral joint, resulted in decreased levels of

  14. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

    PubMed Central

    Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.

    2016-01-01

    Purpose: Arthroscopic transosseous (TO) rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless) rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless) rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM) was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student's t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001). Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES) score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%), good in 8 (7.3%), fair in 3 (2.8%), and poor in 3 (2.8%). There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy) compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of injury preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique leads to

  15. Orgaran (Org 10172) or heparin for preventing venous thrombosis after elective surgery for malignant disease? A double-blind, randomised, multicentre comparison. ANZ-Organon Investigators' Group.

    PubMed

    Gallus, A; Cade, J; Ockelford, P; Hepburn, S; Maas, M; Magnani, H; Bucknall, T; Stevens, J; Porteous, F

    1993-10-18

    This double-blind, randomised, multicentre trial in 513 patients having elective surgery for intra-abdominal or intrathoracic malignancy compared the efficacy and safety of venous thrombosis (VT) prophylaxis using 750 anti-factor Xa units of Orgaran (a mixture of low molecular weight heparinoids) given subcutaneously (sc) twice-daily with that of twice-daily injections of 5,000 units standard heparin. The main study endpoints were the development of postoperative VT detected by 125I-fibrinogen leg scanning, and the onset of clinically significant venous thromboembolism or bleeding. "Intent to treat" analysis showed a statistically non-significant trend towards less VT during Orgaran prophylaxis (10.4%) than after heparin (14.9%) and there was no difference in bleeding complications between the two study groups. Results remained similar if only patients who completed the intended course of therapy ("compliant patients") were analysed. Other trials have shown that Orgaran prevents VT after hip surgery and stroke. We now show it is also safe and effective in patients having major surgery for cancer.

  16. Result from arthroscopic surgical treatment of renewed tearing of the rotator cuff of the shoulder☆

    PubMed Central

    Godinho, Glaydson Gomes; França, Flávio de Oliveira; Freitas, José Márcio Alves; Santos, Flávio Márcio Lago; Prandini, Alexandre; Godinho, André Couto; Costa, Rafael Patrocínio de Paula

    2015-01-01

    Objectives To evaluate function among patients with postoperative recurrence of rotator cuff injuries that was treated arthroscopically (case series) and compare this with function in patients without recurrence (control group); and to compare function among patients with recurrence of rotator cuff injuries that were greater than and smaller than 3 cm. Methods This was a retrospective evaluation of patients who underwent arthroscopic revision of rotator cuff injuries using the ASES, Constant & Murley and UCLA scores and a visual analog pain scale, in comparison with patients in a control group who underwent primary rotator cuff repair. Results The size of the rotator cuff injury recurrence had a statistically significant influence on the result from the arthroscopic surgical treatment. The functional scores showed worse results than those from the first procedure. Conclusion Arthroscopic surgical treatment of renewed tearing of rotator cuff injuries showed worse functional scores than those from primary repair of the injury. PMID:26229900

  17. Treatment options for irreparable postero-superior cuff tears in young patients

    PubMed Central

    Galasso, Olimpio; Familiari, Filippo; Gasparini, Giorgio

    2015-01-01

    Rotator cuff tears (RCTs) occur more commonly with advanced age, with most rotator cuff abnormalities in patients less than 30 years old being painful tendinoses or partial-thickness RCTs. Irreparable postero-superior cuff tears has been reported as frequent as 7% to 10% in the general population, and the incidence of irreparable RCTs in young patients is still unknown. Several surgical procedures have been proposed for young patients with irreparable postero-superior RCTs, such as rotator cuff debridement, partial rotator cuff repair, biceps tenotomy/tenodesis, rotator cuff grafting, latissimus dorsi tendon transfer, and reverse shoulder arthroplasty. After being thoroughly investigated in open surgery, arthroscopic techniques for latissimus dorsi tendon transfer have been recently described. They have been shown to be an adequate option to open surgery for managing irreparable postero-superior RCTs refractory to conservative management. PMID:26601058

  18. The Role of Platelet Rich Plasma (PRP) and Other Biologics for Rotator Cuff Repair

    PubMed Central

    Greenspoon, Joshua A.; Moulton, Samuel G.; Millett, Peter J.; Petri, Maximilian

    2016-01-01

    Background: Surgical treatment of rotator cuff tears has consistently demonstrated good clinical and functional outcomes. However, in some cases, the rotator cuff fails to heal. While improvements in rotator cuff constructs and biomechanics have been made, the role of biologics to aid healing is currently being investigated. Methods: A selective literature search was performed and personal surgical experiences are reported. Results: Biologic augmentation of rotator cuff repairs can for example be performed wtableith platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs). Clinical results on PRP application have been controversial. Application of MSCs has shown promise in animal studies, but clinical data on its effectiveness is presently lacking. The role of Matrix Metalloproteinase (MMP) inhibitors is another interesting field for potential targeted drug therapy after rotator cuff repair. Conclusions: Large randomized clinical studies need to confirm the benefit of these approaches, in order to eventually lower retear rates and improve clinical outcomes after rotator cuff repair.

  19. I.S.Mu.L.T - Rotator Cuff Tears Guidelines

    PubMed Central

    Oliva, Francesco; Piccirilli, Eleonora; Bossa, Michela; Via, Alessio Giai; Colombo, Alessandra; Chillemi, Claudio; Gasparre, Giuseppe; Pellicciari, Leonardo; Franceschetti, Edoardo; Rugiero, Clelia; Scialdoni, Alessandro; Vittadini, Filippo; Brancaccio, Paola; Creta, Domenico; Buono, Angelo Del; Garofalo, Raffaele; Franceschi, Francesco; Frizziero, Antonio; Mahmoud, Asmaa; Merolla, Giovanni; Nicoletti, Simone; Spoliti, Marco; Osti, Leonardo; Padulo, Johnny; Portinaro, Nicola; Tajana, Gianfranco; Castagna, Alex; Foti, Calogero; Masiero, Stefano; Porcellini, Giuseppe; Tarantino, Umberto; Maffulli, Nicola

    2015-01-01

    Despite the high level achieved in the field of shoulder surgery, a global consensus on rotator cuff tears management is lacking. This work is divided into two main sessions: in the first, we set questions about hot topics involved in the rotator cuff tears, from the etiopathogenesis to the surgical treatment. In the second, we answered these questions by mentioning Evidence Based Medicine. The aim of the present work is to provide easily accessible guidelines: they could be considered as recommendations for a good clinical practice developed through a process of systematic review of the literature and expert opinion, in order to improve the quality of care and rationalize the use of resources. PMID:26958532

  20. I.S.Mu.L.T - Rotator Cuff Tears Guidelines.

    PubMed

    Oliva, Francesco; Piccirilli, Eleonora; Bossa, Michela; Via, Alessio Giai; Colombo, Alessandra; Chillemi, Claudio; Gasparre, Giuseppe; Pellicciari, Leonardo; Franceschetti, Edoardo; Rugiero, Clelia; Scialdoni, Alessandro; Vittadini, Filippo; Brancaccio, Paola; Creta, Domenico; Buono, Angelo Del; Garofalo, Raffaele; Franceschi, Francesco; Frizziero, Antonio; Mahmoud, Asmaa; Merolla, Giovanni; Nicoletti, Simone; Spoliti, Marco; Osti, Leonardo; Padulo, Johnny; Portinaro, Nicola; Tajana, Gianfranco; Castagna, Alex; Foti, Calogero; Masiero, Stefano; Porcellini, Giuseppe; Tarantino, Umberto; Maffulli, Nicola

    2015-01-01

    Despite the high level achieved in the field of shoulder surgery, a global consensus on rotator cuff tears management is lacking. This work is divided into two main sessions: in the first, we set questions about hot topics involved in the rotator cuff tears, from the etiopathogenesis to the surgical treatment. In the second, we answered these questions by mentioning Evidence Based Medicine. The aim of the present work is to provide easily accessible guidelines: they could be considered as recommendations for a good clinical practice developed through a process of systematic review of the literature and expert opinion, in order to improve the quality of care and rationalize the use of resources. PMID:26958532

  1. Prognosis Driven Rehabilitation After Rotator Cuff Repair Surgery

    PubMed Central

    Kokmeyer, Dirk; Dube, Eric; Millett,, Peter J.

    2016-01-01

    Background: Rehabilitation after rotator cuff repair surgery has been the focus of several clinical trials in the past decade. Many illuminate new evidence with regard to the prognosis of structural and functional success after surgery. Methods: A selective literature search was performed and personal physiotherapeutic and surgical experiences are reported. Results: Post-operative rehabilitation parameters, namely the decision to delay or allow early range of motion after surgery, play a large role in the overall success after surgery. Using a prognosis driven rehabilitation program offers clinicians a means of prescribing optimal rehabilitation parameters while ensuring structural and functional success. This commentary aims to synthesize the evidence in a spectrum of prognostic factors to guide post-operative rehabilitation. Conclusion: The optimal rehabilitation program after rotator cuff repair surgery is debatable; therefore, we suggest using a spectrum of prognostic factors to determine a rehabilitation program suited to ensure structural and functional success, quickly and safely. PMID:27708736

  2. Wearable PWV technologies to measure Blood Pressure: eliminating brachial cuffs.

    PubMed

    Solá, J; Proença, M; Chételat, O

    2013-01-01

    The clinical demand for technologies to monitor Blood Pressure (BP) in ambulatory scenarios with minimal use of inflation cuffs is strong: new generation of BP monitors are expected to be not only accurate, but also non-occlusive. In this paper we review recent advances on the use of the so-called Pulse Wave Velocity (PWV) technologies to estimate BP in a beat-by-beat basis. After introducing the working principle and underlying methodological limitations, two implementation examples are provided. Pilot studies have demonstrated that novel PWV-based BP monitors depict accuracy scores falling within the limits of the British Hypertensive Society (BHS) Grade A standard. The reported techniques pave the way towards ambulatory-compliant, continuous and non-occlusive BP monitoring devices, where the use of inflation cuffs is drastically reduced. PMID:24110633

  3. Evaluation of Internet Information About Rotator Cuff Repair.

    PubMed

    Lawson, Kevin A; Codella, Stephen; Ciccotti, Michael G; Kane, Patrick W; Duncan, Ian C; Cohen, Steven B

    2016-01-01

    The content and quality of Internet websites are not governed or regulated. Therefore, patients who consult the Internet may receive outdated or incorrect medical information. Researchers have analyzed the quality of web information about various orthopedic surgeries, but no such analysis has been performed on websites covering rotator cuff repair. We conducted a study to evaluate and analyze rotator cuff repair information available to the general public through the Internet; to assess changes in the quality of information over time; to determine if sites sponsored by academic institutions offered higher-quality information; and to assess whether the readability of the material varied according to DISCERN scores. Two Internet searches were conducted, in 2011 and 2014. The 3 most commonly used search engines were used to search for rotator cuff repair. The first 50 websites from each search engine were evaluated for authorship and content. The DISCERN instrument was used to analyze the quality of each website's health information. The 2011 search revealed 21% of websites were associated with an academic institution, 38% were authored by a hospital or physician group, and 11.5% were industry-sponsored. The 2014 search revealed a similar distribution of contributors. The highest DISCERN scores were given to academic institution websites (51.6) and public education websites (49). There was no correlation between readability and DISCERN scores. Websites associated with academic institutions produced the highest-quality medical information. Over the past few years, authorship and content have changed little with respect to Internet information about rotator cuff repair.

  4. Gender Affects Early Postoperative Outcomes of Rotator Cuff Repair

    PubMed Central

    Ye, Hee-Uk; Jung, Jae-Won; Lee, Young-Kuk

    2015-01-01

    Background The literature does not provide consistent information on the impact of patients' gender on recovery after rotator cuff repair. The purpose of this study was to determine whether gender affects pain and functional recovery in the early postoperative period after rotator cuff repair. Methods Eighty patients (40 men and 40 women) were prospectively enrolled. Pain intensity and functional recovery were evaluated, using visual analog scale (VAS) pain score and range of motion on each of the first 5 postoperative days, at 2 and 6 weeks and at 3, 6, and 12 months after surgery. Perioperative medication-related adverse effects and postoperative complications were also assessed. Results The mean VAS pain score was significantly higher for women than men at 2 weeks after surgery (p = 0.035). For all other periods, there was no significant difference between men and women in VAS pain scores, although women had higher scores than men. Mean forward flexion in women was significantly lower than men at 6 weeks after surgery (p = 0.033) and the mean degree of external rotation in women was significantly lower than men at 6 weeks (p = 0.007) and at 3 months (p = 0.017) after surgery. There was no significant difference in medication-related adverse effects or postoperative complications. Conclusions Women had more pain and slower recovery of shoulder motion than men during the first 3 months after rotator cuff repair. These findings can serve as guidelines for pain management and rehabilitation after surgery and can help explain postoperative recovery patterns to patients with scheduled rotator cuff repair. PMID:26217471

  5. Chronic rotator cuff impingement in the throwing athlete.

    PubMed

    Jackson, D W

    1976-01-01

    Compromise of the space between the humeral head and the coracoacromial arch may be a source of chronic shoulder pain associated with rotator cuff impingement in the athlete participating in throwing sports. In certain carefully selected individuals, surgical decompression may alleviate these symptoms. The surgical procedure can be done under local anesthesia and may enable the athlete to return to his previous level of performance without disability.

  6. Management of the throwing shoulder: cuff, labrum and internal impingement.

    PubMed

    Greiwe, R Michael; Ahmad, Christopher S

    2010-07-01

    Repetitive throwing or other overhead activity places great stress on the shoulder. As a result, the shoulder is a common site of injury in athletes. Addressing throwing-related injuries requires an understanding of throwing biomechanics and pathology. Nonoperative treatment is directed at restoring strength, flexibility, and neuromuscular control to the entire kinetic chain. Surgery is indicated when nonoperative treatment fails, and is directed at correcting labral, capsular, and rotator cuff pathology.

  7. Efficacy and safety of betahistine treatment in patients with Meniere’s disease: primary results of a long term, multicentre, double blind, randomised, placebo controlled, dose defining trial (BEMED trial)

    PubMed Central

    Adrion, Christine; Fischer, Carolin Simone; Wagner, Judith; Gürkov, Robert; Mansmann, Ulrich

    2016-01-01

    Study question What is the long term efficacy of betahistine dihydrochloride on the incidence of vertigo attacks in patients with Meniere’s disease, compared with placebo? Methods The BEMED trial is a multicentre, double blind, randomised, placebo controlled, three arm, parallel group, phase III, dose defining superiority trial conducted in 14 German tertiary referral centres (for neurology or ear, nose, and throat). Adults aged 21-80 years (mean age 56 years) with definite unilateral or bilateral Meniere’s disease were recruited from March 2008 to November 2012. Participants received placebo (n=74), low dose betahistine (2×24 mg daily, (n=73)), or high dose betahistine (3×48 mg daily, (n=74)) over nine months. The primary outcome was the number of attacks per 30 days, based on patients’ diaries during a three month assessment period at months seven to nine. An internet based randomisation schedule performed a concealed 1:1:1 allocation, stratified by study site. Secondary outcomes included the duration and severity of attacks, change in quality of life scores, and several observer-reported parameters to assess changes in audiological and vestibular function. Study answer and limitations Incidence of attacks related to Meniere’s disease did not differ between the three treatment groups (P=0.759). Compared with placebo, attack rate ratios were 1.036 (95% confidence interval 0.942 to 1.140) and 1.012 (0.919 to 1.114) for low dose and high dose betahistine, respectively. The overall monthly attack rate fell significantly by the factor 0.758 (0.705 to 0.816; P<0.001). The population based, mean monthly incidence averaged over the assessment period was 2.722 (1.304 to 6.309), 3.204 (1.345 to 7.929), and 3.258 (1.685 to 7.266) for the placebo, low dose betahistine, and high dose betahistine groups, respectively. Results were consistent for all secondary outcomes. Treatment was well tolerated with no unexpected safety findings. Without a control group of

  8. Non-Operative Management of Rotator Cuff Tears

    PubMed Central

    Petri, M.; Ettinger, M.; Brand, S.; Stuebig, T.; Krettek, C.; Omar, M.

    2016-01-01

    Background: The role of nonoperative management for rotator cuff tears remains a matter of debate. Clinical results reported in the literature mainly consist of level IV studies, oftentimes combining a mixed bag of tear sizes and configurations, and are contradictory to some extent. Methods: A selective literature search was performed and personal surgical experiences are reported. Results: Most studies show an overall success rate of around 75% for nonoperative treatment. However, the majority of studies also present a progression of tear size and fatty muscle infiltration over time, with however debatable clinical relevance for the patient. Suggested factors associated with progression of a rotator cuff tear are an age of 60 years or older, full-thickness tears, and fatty infiltration of the rotator cuff muscles at the time of initial diagnosis. Conclusion: Non-operative management is indicated for patients with lower functional demands and moderate symptoms, and/or of course for those refusing to have surgery. Close routinely monitoring regarding development of tear size should be performed, especially in patients that remain symptomatic during nonoperative treatment. To ensure judicious patient counseling, it has to be taken into account that 1) tears that are initially graded as reparable may become irreparable over time, and 2) results after secondary surgical therapy after failed nonoperative treatment are usually reported to be inferior to those who underwent primary tendon repair.

  9. EXTENSIVE ROTATOR CUFF INJURIES: AN EVALUATION OF ARTHROSCOPIC REPAIR OUTCOMES

    PubMed Central

    Miyazaki, Alberto Naoki; Fregoneze, Marcelo; Santos, Pedro Doneux; Silva, Luciana Andrade; Eduardo, Cesar Moreira Mariz Pinto Rodrigo Tormin Ortiz; Checchia, Sergio Luiz

    2015-01-01

    To assess the outcomes of the surgical treatment of extensive rotator cuff injuries through arthroscopy. Methods: Between June 1998 and October 2006, 61 patients with extensive rotator cuff injuries and submitted to surgical arthroscopy technique by the Shoulder and Elbow Group of the Department of Orthopaedics and Traumatology, Santa Casa de Misericórdia Medical School were reassessed. The study included all patients with at least two tendons affected or with retraction at least on two tendons up to the glenoidal cavity edge and with at least 12 months of follow-up. Results: According to UCLA's evaluation criteria, 54 (89%) patients showed excellent or good outcomes; no fair outcome in none of the patients; and seven (11%) poor outcomes. A satisfaction rate of 92% was reported. Postoperative joint motion went from a mean lifting value of 93° to 141°, the mean lateral rotation went from 32° to 48° and the mean medial rotation went from L1 to T10. These differences were regarded as statistically significant. Conclusion: The arthroscopic repair of extensive rotator cuff injuries leads to satisfactory outcomes for most of the patients, with a high satisfaction degree. PMID:26998466

  10. Management of failed rotator cuff repair: a systematic review

    PubMed Central

    Lädermann, Alexandre; Denard, Patrick J; Burkhart, Stephen S

    2016-01-01

    Importance Recurrent tear after rotator cuff repair (RCR) is common. Conservative, and open and arthroscopic revisions, have been advocated to treat these failures. Aim or objective The purpose of this systematic review was to evaluate the different options for managing recurrent rotator cuff tears. Evidence review A search was conducted of level I through 4 studies from January 2000 to October 2015, to identify studies reporting on failed RCR. 10 articles were identified. The overall quality of evidence was very low. Findings Mid-term to long-term follow-up of patients treated conservatively revealed acceptable results; a persistent defect is a well-tolerated condition that only occasionally requires subsequent surgery. Conservative treatment might be indicated in most patients, particularly in case of posterosuperior involvement and poor preoperative range of motion. Revision surgery might be indicated in a young patient with a repairable lesion, a 3 tendon tear, and in those with involvement of the subscapularis. Conclusions and relevance The current review indicates that arthroscopic revision RCR can lead to improvement in functional outcome despite a high retear rate. Further studies are needed to develop specific rehabilitation in the case of primary rotator cuff failure, to better understand the place of each treatment option, and, in case of repair, to optimise tendon healing. PMID:27134759

  11. Augmented Fixation With Biodegradable Subacromial Spacer After Repair of Massive Rotator Cuff Tear

    PubMed Central

    Bozkurt, Murat; Akkaya, Mustafa; Gursoy, Safa; Isik, Cetin

    2015-01-01

    Unsuccessful outcomes after repair of massive rotator cuff ruptures accompanied by muscle atrophy and fatty degeneration are frequently associated with inadequate management and secondary tears. We report the functional differences after rotator cuff rupture repair with a biodegradable spacer application. In these patients, rotator cuff rupture repair should provide coverage of the humeral head. Subsequently, acromioplasty should be performed to allow adequate space for the subacromial spacer. Thereafter measurement of the intra-articular space required for application of the biodegradable spacer is performed. Using this method can decrease the rate of tears by providing a safe subacromial space in cases of massive rotator cuff rupture. PMID:26697306

  12. Azithromycin and cough-specific health status in patients with chronic obstructive pulmonary disease and chronic cough: a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Macrolides reduce exacerbations in patients with COPD. Their effects on health status has not been assessed as primary outcome and is less clear. This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough. Methods In this randomised controlled trial 84 patients met the eligibility criteria: age of ≥40 years, COPD GOLD stage ≥2 and chronic productive cough. The intervention-group (n = 42) received azithromycin 250 mg 3 times a week and the control-group (n = 42) received a placebo. Primary outcome was cough-specific health status at 12 weeks, measured with the Leicester Cough Questionnaire (LCQ). Secondary outcomes included generic and COPD-specific health status and exacerbations. Changes in adverse events and microbiology were monitored. Results Mean age of participants was 68 ± 10 years and mean FEV1 was 1.36 ± 0.47 L. The improvement in LCQ total score at 12 weeks was significantly greater with azithromycin (difference 1.3 ± 0.5, 95% CI 0.3;2.3, p = 0.01) and met the minimal clinically important difference. Similar results were found for the domain scores, and COPD-specific and generic health status questionnaires. Other secondary endpoints were non-significant. No imbalances in adverse events were found. Conclusions Prophylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree. Trial registration ClinicalTrials.gov NCT01071161 PMID:24229360

  13. Vitamin D and the immunomodulation of rotator cuff injury.

    PubMed

    Dougherty, Kaitlin A; Dilisio, Matthew F; Agrawal, Devendra K

    2016-01-01

    Tendon-to-bone healing after rotator cuff repair surgery has a failure rate of 20%-94%. There has been a recent interest to determine the factors that act as determinants between successful and unsuccessful rotator cuff repair. Vitamin D level in patients is one of the factors that have been linked to bone and muscle proliferation and healing, and it may have an effect on tendon-to-bone healing. The purpose of this article is to critically review relevant published research that relates to the effect of vitamin D on rotator cuff tears and subsequent healing. A review of the literature was conducted to identify all studies that investigate the relationship between vitamin D and tendon healing, in addition to its mechanism of action. The data were then analyzed in order to summarize what is currently known about vitamin D, rotator cuff pathology, and tendon-to-bone healing. The activated metabolite of vitamin D, 1α,25-dihydroxyvitamin D3, affects osteoblast proliferation and differentiation. Likewise, vitamin D plays a significant role in the tendon-to-bone healing process by increasing the bone mineral density and strengthening the skeletal muscles. The 1α,25-dihydroxyvitamin D3 binds to vitamin D receptors on myocytes to stimulate growth and proliferation. The form of vitamin D produced by the liver, calcifediol, is a key initiator of the myocyte healing process by moving phosphate into myocytes, which improves function and metabolism. Investigation into the effect of vitamin D on tendons has been sparse, but limited studies have been promising. Matrix metalloproteinases play an active role in remodeling the extracellular matrix (ECM) of tendons, particularly deleterious remodeling of the collagen fibers. Also, the levels of transforming growth factor-β3 positively influence the success of the surgery for rotator cuff repair. In the tendon-to-bone healing process, vitamin D has been shown to successfully influence bone and muscle healing, but more research is

  14. Vitamin D and the immunomodulation of rotator cuff injury

    PubMed Central

    Dougherty, Kaitlin A; Dilisio, Matthew F; Agrawal, Devendra K

    2016-01-01

    Tendon-to-bone healing after rotator cuff repair surgery has a failure rate of 20%–94%. There has been a recent interest to determine the factors that act as determinants between successful and unsuccessful rotator cuff repair. Vitamin D level in patients is one of the factors that have been linked to bone and muscle proliferation and healing, and it may have an effect on tendon-to-bone healing. The purpose of this article is to critically review relevant published research that relates to the effect of vitamin D on rotator cuff tears and subsequent healing. A review of the literature was conducted to identify all studies that investigate the relationship between vitamin D and tendon healing, in addition to its mechanism of action. The data were then analyzed in order to summarize what is currently known about vitamin D, rotator cuff pathology, and tendon-to-bone healing. The activated metabolite of vitamin D, 1α,25-dihydroxyvitamin D3, affects osteoblast proliferation and differentiation. Likewise, vitamin D plays a significant role in the tendon-to-bone healing process by increasing the bone mineral density and strengthening the skeletal muscles. The 1α,25-dihydroxyvitamin D3 binds to vitamin D receptors on myocytes to stimulate growth and proliferation. The form of vitamin D produced by the liver, calcifediol, is a key initiator of the myocyte healing process by moving phosphate into myocytes, which improves function and metabolism. Investigation into the effect of vitamin D on tendons has been sparse, but limited studies have been promising. Matrix metalloproteinases play an active role in remodeling the extracellular matrix (ECM) of tendons, particularly deleterious remodeling of the collagen fibers. Also, the levels of transforming growth factor-β3 positively influence the success of the surgery for rotator cuff repair. In the tendon-to-bone healing process, vitamin D has been shown to successfully influence bone and muscle healing, but more research is

  15. A randomised, double-blind, placebo-controlled, crossover study to assess the efficacy and safety of three dosing schedules of agalsidase alfa enzyme replacement therapy for Fabry disease.

    PubMed

    Hughes, D A; Deegan, P B; Milligan, A; Wright, N; Butler, L H; Jacobs, A; Mehta, A B

    2013-07-01

    Anecdotal reports suggest that the currently approved dosing interval of agalsidase alfa (0.2 mg/kg/2 weeks) for Fabry disease treatment is too long. This randomised, double-blind, placebo-controlled, crossover study investigated three altered dosing intervals. 18 Fabry patients received three agalsidase alfa dosing schedules, each for four weeks (A: 0.2 mg/kg∗2 weeks, B: 0.1 mg/kg/week, C: 0.2 mg/kg/week). Health state, pain levels, sweat volume and latency and plasma and urinary globotriaosylceramide levels were recorded throughout the study. No significant differences were found among the schedules for the primary efficacy outcome of self-assessed health state, or for pain scores. A trend toward increased sweat volume on QSART testing, and reduced urine globotriaosylceramide concentration were seen with treatment schedule C. Agalsidase alfa was safe and well tolerated with all schedules. In conclusion, the primary analyses did not find weekly infusions of agalsidase alfa to be statistically better than the approved dosing schedule however the data indicates that further studies with more patients over a longer period are required to more accurately determine the optimum dose and schedule. PMID:23702393

  16. Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial

    PubMed Central

    Farmer, Andrew; Toms, Christy; Hardinge, Maxine; Williams, Veronika; Rutter, Heather; Tarassenko, Lionel

    2014-01-01

    Introduction The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education. Methods and analysis The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months. Ethics and dissemination The Research Ethics Committee for Berkshire—South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the

  17. Arthroscopic Superior Capsule Reconstruction for Irreparable Rotator Cuff Tears

    PubMed Central

    Mihata, Teruhisa; Lee, Thay Q.; Itami, Yasuo; HASEGAWA, Akihiko; Ohue, Mutsumi; Neo, Masashi

    2016-01-01

    Objectives: An arthroscopic superior capsule reconstruction, in which the fascia lata autograft attached medially to the superior glenoid and laterally to the greater tuberosity, restores shoulder stability and muscle balance in patients with irreparable rotator cuff tears; consequently, it improves shoulder function specifically deltoid muscle function and relieves pain. We assessed the clinical outcome of arthroscopic superior capsule reconstruction (Figure 1) in 100 consecutive patients with irreparable rotator cuff tears. Specifically, we focused on the rates of return to sport and work. Methods: From 2007 to 2014, we performed arthroscopic superior capsule reconstruction on 107 consecutive patients (mean 66.7 years; range, 43 to 82) with irreparable rotator cuff tears that had failed conservative treatment. Seven patients were lost to follow-up because of other medical problems or reasons. In the remaining 100 patients there were 56 supraspinatus and infraspinatus tears; 39 supraspinatus, infraspinatus, and subscapularis tears; 3 supraspinatus, infraspinatus, teres minor, and subscapularis tears; and 2 supraspinatus, infraspinatus, and teres minor tears. Physical examination, radiography, and MRI were performed before surgery; at 3, 6, and 12 months after surgery; and yearly thereafter. Rates of return to sport and work were also investigated in those patients who had been employed (34 patients: 21 manual workers, 10 farmers, 1 butcher, 1 cook, and 1 athletic trainer) or played sport (26 patients: 6 golf, 4 table tennis, 4 swimming, 3 martial arts, 2 baseball, 2 yoga, 1 tennis, 1 badminton, 1 skiing, 1 mountain-climbing, and 1 ground golf) before injury. Results: The average preoperative American Shoulder and Elbow Surgeons (ASES) score was 31.6 points (range, 3.3 to 63.3 points) and the average Japanese Orthopaedic Association (JOA) score was 51.6 points (26.5 to 68.5 points). Average postoperative clinical outcome scores all improved significantly at final

  18. Assessment of musculoskeletal pain sensitivity and temporal summation by cuff pressure algometry: a reliability study.

    PubMed

    Graven-Nielsen, Thomas; Vaegter, Henrik Bjarke; Finocchietti, Sara; Handberg, Gitte; Arendt-Nielsen, Lars

    2015-11-01

    Chronic musculoskeletal pain is linked with sensitization, and standardized methods for assessment are needed. This study investigated (1) the test-retest reliability of computer-controlled cuff-pressure algometry (pain thresholds and temporal pain summation) on the arm and leg and (2) conditioned pain modulation (CPM) assessed by cuff algometry. The influences of age and gender were evaluated. On 2 different days, cuff pain threshold (cPPT), cuff pain tolerance (cPTT), and temporal summation of pain (TSP) by visual analog scale scores to 10 repeated cuff stimulations at cPTT intensity, as well as pressure pain threshold with handheld pressure algometry, were assessed in 136 healthy subjects. In one session, cuff pain sensitivity was also assessed before and after cold pressor-induced CPM. Good-to-excellent intraclass correlations (0.60-0.90) were demonstrated for manual and cuff algometry, and no systematic bias between sessions was found for cPPT, cPTT, and TSP on the leg and for cPTT and TSP on the arm. Cuff pressure pain threshold and cPTT were higher in men compared with women (P < 0.05). Middle-aged subjects had higher pressure pain threshold, but lower cPPT and cPTT, compared with younger subjects (P < 0.05). Temporal summation of pain was increased in women compared with men (P < 0.05). Cuff algometry was sensitive to CPM demonstrated as increased cPPT and cPTT and reduced TSP (P < 0.05). Reliability and sensitivity of computer-controlled cuff algometry for pain assessment is comparable with manual pressure algometry and constitutes a user-independent method for assessment of pain. Difference in age-related pain sensitivity between manual and cuff algometry should be further investigated.

  19. Assessment of musculoskeletal pain sensitivity and temporal summation by cuff pressure algometry: a reliability study.

    PubMed

    Graven-Nielsen, Thomas; Vaegter, Henrik Bjarke; Finocchietti, Sara; Handberg, Gitte; Arendt-Nielsen, Lars

    2015-11-01

    Chronic musculoskeletal pain is linked with sensitization, and standardized methods for assessment are needed. This study investigated (1) the test-retest reliability of computer-controlled cuff-pressure algometry (pain thresholds and temporal pain summation) on the arm and leg and (2) conditioned pain modulation (CPM) assessed by cuff algometry. The influences of age and gender were evaluated. On 2 different days, cuff pain threshold (cPPT), cuff pain tolerance (cPTT), and temporal summation of pain (TSP) by visual analog scale scores to 10 repeated cuff stimulations at cPTT intensity, as well as pressure pain threshold with handheld pressure algometry, were assessed in 136 healthy subjects. In one session, cuff pain sensitivity was also assessed before and after cold pressor-induced CPM. Good-to-excellent intraclass correlations (0.60-0.90) were demonstrated for manual and cuff algometry, and no systematic bias between sessions was found for cPPT, cPTT, and TSP on the leg and for cPTT and TSP on the arm. Cuff pressure pain threshold and cPTT were higher in men compared with women (P < 0.05). Middle-aged subjects had higher pressure pain threshold, but lower cPPT and cPTT, compared with younger subjects (P < 0.05). Temporal summation of pain was increased in women compared with men (P < 0.05). Cuff algometry was sensitive to CPM demonstrated as increased cPPT and cPTT and reduced TSP (P < 0.05). Reliability and sensitivity of computer-controlled cuff algometry for pain assessment is comparable with manual pressure algometry and constitutes a user-independent method for assessment of pain. Difference in age-related pain sensitivity between manual and cuff algometry should be further investigated. PMID:26172551

  20. Evaluation of an Intervention to Maintain Endotracheal Tube Cuff Pressure Within Therapeutic Range

    PubMed Central

    Sole, Mary Lou; Su, Xiaogang; Talbert, Steve; Penoyer, Daleen Aragon; Kalita, Samar; Jimenez, Edgar; Ludy, Jeffery E.; Bennett, Melody

    2012-01-01

    Background Endotracheal tube cuff pressure must be kept within an optimal range that ensures ventilation and prevents aspiration while maintaining tracheal perfusion. Objectives To test the effect of an intervention (adding or removing air) on the proportion of time that cuff pressure was between 20 and 30 cm H2O and to evaluate changes in cuff pressure over time. Methods A repeated-measure crossover design was used to study 32 orally intubated patients receiving mechanical ventilation for two 12-hour shifts (randomized control and intervention conditions). Continuous cuff pressure monitoring was initiated, and the pressure was adjusted to a minimum of 22 cm H2O. Caregivers were blinded to cuff pressure data, and usual care was provided during the control condition. During the intervention condition, cuff pressure alarm or clinical triggers guided the intervention. Results Most patients were men (mean age, 61.6 years). During the control condition, 51.7% of cuff pressure values were out of range compared with 11.1% during the intervention condition (P < .001). During the intervention, a mean of 8 adjustments were required, mostly to add air to the endotracheal tube cuff (mean 0.28 [SD, 0.13] mL). During the control condition, cuff pressure decreased over time (P < .001). Conclusions The intervention was effective in maintaining cuff pressure within an optimal range, and cuff pressure decreased over time without intervention. The effect of the intervention on outcomes such as ventilator-associated pneumonia and tracheal damage requires further study. PMID:21362715

  1. Editorial Commentary: Save the Subchondral Bone in Rotator Cuff Repair Greater Tuberosity Preparation.

    PubMed

    Brand, Jefferson C

    2016-04-01

    Results from a recent investigation into the practice of greater tuberosity decortication before rotator cuff repair showed that decortication significantly reduced the ultimate failure load. Although the potential of greater tuberosity treatment for solving the rotator cuff healing quandary still exists, the biomechanics are clear, one should not decorticate the greater tuberosity to cancellous bone. PMID:27039677

  2. REHABILITATION AFTER ARTHROSCOPIC ROTATOR CUFF REPAIR: CURRENT CONCEPTS REVIEW AND EVIDENCE-BASED GUIDELINES

    PubMed Central

    Westgard, Paul; Chandler, Zachary; Gaskill, Trevor R.; Kokmeyer, Dirk; Millett, Peter J.

    2012-01-01

    Purpose: To provide an overview of the characteristics and timing of rotator cuff healing and provide an update on treatments used in rehabilitation of rotator cuff repairs. The authors' protocol of choice, used within a large sports medicine rehabilitation center, is presented and the rationale behind its implementation is discussed. Background: If initial nonsurgical treatment of a rotator cuff tear fails, surgical repair is often the next line of treatment. It is evident that a successful outcome after surgical rotator cuff repair is as much dependent on surgical technique as it is on rehabilitation. To this end, rehabilitation protocols have proven challenging to both the orthopaedic surgeon and the involved physical therapist. Instead of being based on scientific rationale, traditionally most rehabilitation protocols are solely based on clinical experience and expert opinion. Methods: A review of currently available literature on rehabilitation after arthroscopic rotator cuff tear repair on PUBMED / MEDLINE and EMBASE databases was performed to illustrate the available evidence behind various postoperative treatment modalities. Results: There is little high-level scientific evidence available to support or contest current postoperative rotator cuff rehabilitation protocols. Most existing protocols are based on clinical experience with modest incorporation of scientific data. Conclusion: Little scientific evidence is available to guide the timing of postsurgical rotator cuff rehabilitation. To this end, expert opinion and clinical experience remains a large facet of rehabilitation protocols. This review describes a rotator cuff rehabilitation protocol that incorporates currently available scientific literature guiding rehabilitation. PMID:22530194

  3. Evaluation of tracheal cuff pressure variation in spontaneously breathing patients

    PubMed Central

    Plotnikow, Gustavo A; Roux, Nicolas; Feld, Viviana; Gogniat, Emiliano; Villalba, Dario; Ribero, Noelia Vairo; Sartore, Marisa; Bosso, Mauro; Quiroga, Corina; Leiva, Valeria; Scrigna, Mariana; Puchulu, Facundo; Distéfano, Eduardo; Scapellato, Jose Luis; Intile, Dante; Planells, Fernando; Noval, Diego; Buñirigo, Pablo; Jofré, Ricardo; Nielsen, Ernesto Díaz

    2013-01-01

    Background: Most of the studies referring cuff tubes’ issues were conducted on intubated patients. Not much is known about the cuff pressure performance in chronically tracheostomized patients disconnected from mechanical ventilation. Objective: To evaluate cuff pressure (CP) variation in tracheostomized, spontaneously breathing patients in a weaning rehabilitation center. Materials and Methods: Experimental setup to test instruments in vitro, in which the gauge (TRACOE) performance at different pressure levels was evaluated in six tracheostomy tubes, and a clinical setupin which CP variation over 24 h, every 4 h, and for 6 days was measured in 35 chronically tracheostomized clinically stable, patients who had been disconnected from mechanical ventilation for at least 72 h. The following data were recorded: Tube brand, type, and size; date of the tube placed; the patient's body position; the position of the head; axillary temperature; pulse and respiration rates; blood pressure; and pulse oximetry. Results: In vitro difference between the initial pressure (IP) and measured pressure (MP) was statistically significant (P < 0.05). The difference between the IP and MP was significant when selecting for various tube brands (P < 0.05). In the clinical set-up, 207 measurements were performed and the CP was >30 cm H2O in 6.28% of the recordings, 20-30 cm H2O in 42.0% of the recordings, and <20 cm H2O in 51.69% of the recordings. Conclusion: The systematic CP measurement in chronically tracheostomized, spontaneously breathing patients showed high variability, which was independent of tube brand, size, type, or time of placement. Consequently, measurements should be made more frequently. PMID:24459624

  4. Association between alcohol consumption and rotator cuff tear

    PubMed Central

    Passaretti, Daniele; Candela, Vittorio; Venditto, Teresa; Giannicola, Giuseppe; Gumina, Stefano

    2016-01-01

    Background and purpose — Long-term alcohol intake is associated with various negative effects on capillary microcirculation and tissue perfusion. We hypothesized that alcohol consumption might be a risk factor for both the occurrence and the severity of rotator cuff tears (RCTs). Patients and methods — A case-control study was performed. We studied 249 consecutive patients (139 men and 110 women; mean age 64 (54–78) years) who underwent arthroscopic rotator cuff repair. Tear size was determined intraoperatively. The control group had 356 subjects (186 men and 170 women; mean age 66 (58–82) years) with no RCT. All participants were questioned about their alcohol intake. Participants were divided into: (1) non-drinkers if they consumed less than 0.01 g of ethanol per day, and (2) moderate drinkers and (3) excessive drinkers if women (men) consumed > 24 g (36 g) per day for at least 2 years. Results — Total alcohol consumption, wine consumption, and duration of alcohol intake were higher in both men and women with RCT than in both men and women in the control group. Excessive alcohol consumption was found to be a risk factor for the occurrence of RCT in both sexes (men: OR = 1.7, 95% CI: 1.2–3.9; women: OR = 1.9, 95% CI: 0.94–4.1). Massive tears were associated with a higher intake of alcohol (especially wine) than smaller lesions. Interpretation — Long-term alcohol intake is a significant risk factor for the occurrence and severity of rotator cuff tear in both sexes. PMID:26610042

  5. Editorial Commentary: Arthroscopic Rotator Cuff Repair--Infection Rate After Rotator Cuff Repair With Arthroscopic, Open, and Mini-open Techniques.

    PubMed

    Brand, Jefferson C

    2016-03-01

    In "Risk Factors for Infection After Rotator Cuff Repair," B. G. Vopat et al. report a lower rate of postoperative infection with an arthroscopic rotator cuff repair than with an open or mini-open approach. Although there were only 14 infections (infection rate of 0.77%), the reason for the preponderance of male patients, 13 of the 14 infections, needs further research to determine effective preventive strategies.

  6. Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study

    PubMed Central

    Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

    2016-01-01

    Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. Methods and analysis The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. Ethics and dissemination The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. Trial registration number 32017426, pre-results. PMID:27609859

  7. The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with moderate and severe chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial

    PubMed Central

    Casey, Dympna; Murphy, Kathy; Devane, Declan; Cooney, Adeline; McCarthy, Bernard; Mee, Lorraine; Newell, John; O'Shea, Eamon; Scarrott, Carl; Gillespie, Paddy; Kirwan, Collette; Murphy, Andrew W

    2013-01-01

    Objective To evaluate the effectiveness of a structured education pulmonary rehabilitation programme on the health status of people with chronic obstructive pulmonary disease (COPD). Design Two-arm, cluster randomised controlled trial. Setting 32 general practices in the Republic of Ireland. Participants 350 participants with a diagnosis of moderate or severe COPD. Intervention Experimental group received a structured education pulmonary rehabilitation programme, delivered by the practice nurse and physiotherapist. Control group received usual care. Main outcome measure Health status as measured by the Chronic Respiratory Questionnaire (CRQ) at baseline and at 12–14 weeks postcompletion of the programme. Results Participants allocated to the intervention group had statistically significant higher mean change total CRQ scores (adjusted mean difference (MD) 1.11, 95% CI 0.35 to 1.87). However, the CI does not exclude a smaller difference than the one that was prespecified as clinically important. Participants allocated to the intervention group also had statistically significant higher mean CRQ Dyspnoea scores after intervention (adjusted MD 0.49, 95% CI 0.20 to 0.78) and CRQ Physical scores (adjusted MD 0.37, 95% CI 0.14 to 0.60). However, CIs for both the CRQ Dyspnoea and CRQ Physical subscales do not exclude smaller differences as prespecified as clinically important. No other statistically significant differences between groups were seen. Conclusions A primary care based structured education pulmonary rehabilitation programme is feasible and may increase local accessibility to people with moderate and severe COPD. Trial registration ISRCTN52403063. PMID:23736156

  8. GuidAge study: a 5-year double blind, randomised trial of EGb 761 for the prevention of Alzheimer's disease in elderly subjects with memory complaints. i. rationale, design and baseline data.

    PubMed

    Andrieu, Sandrine; Ousset, Pierre-Jean; Coley, Nicola; Ouzid, Mehemed; Mathiex-Fortunet, Hélène; Vellas, Bruno

    2008-08-01

    Primary and secondary prevention strategies for Alzheimer's disease (AD) are urgently needed. We have initiated a five-year prospective prevention study involving patients spontaneously reporting memory complaints. The primary objective is to determine the effect of treatment with EGb 76 on the rate of conversion from memory complaints to AD using survival analysis. Ambulatory patients aged at least 70 years who spontaneously reported a memory complaint during a GP or memory centre consultation were eligible for inclusion. Patients with major objective memory impairment or clinically relevant symptoms of anxiety and depression were excluded. Subjects were randomised to receive either EGb 761 120mg bid or matching placebo. Participants undergo an annual visit at a memory centre, where a series of neuropsychological tests are administered to assess cognitive function (Grober and Buschke, Trail-Making and controlled oral word association tests) and cognitive status (MMS and CDR). Functional status is evaluated with the Instrumental Activities of Daily Living questionnaire. The primary outcome is the transition to a diagnosis of AD (DSM-IV and NINCDS-ADRDA criteria), determined at the annual memory centre visit. A total of 4066 patients were screened for participation, of whom 2854 fulfilled the eligibility criteria and were entered into the study. Their mean age was 76.8+/-4.4 years and 66.7% were female. The mean MMSE score was 27.8+/-1.7 and 55.5% presented a CDR score of 0.5. This study will enable us to evaluate the efficacy of EGb761 in the prevention of AD, and to assess the usefulness of various baseline characteristics as predictors of conversion to AD in this population.

  9. Safety and efficacy of liraglutide in patients with type 2 diabetes and end-stage renal disease: protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded, parallel intervention study

    PubMed Central

    Idorn, Thomas; Knop, Filip K; Jørgensen, Morten; Jensen, Tonny; Resuli, Marsela; Hansen, Pernille M; Christensen, Karl B; Holst, Jens J; Hornum, Mads; Feldt-Rasmussen, Bo

    2013-01-01

    Introduction Diabetes is the leading cause of end-stage renal disease (ESRD). Owing to renal clearance, several antidiabetic agents cannot be used in patients with ESRD. The present protocol describes an investigator-initiated trial aiming to test safety and efficacy of treatment with the glucagon-like peptide-1 receptor agonist liraglutide in patients with type 2 diabetes and dialysis-dependent ESRD. Methods and analysis Twenty patients with type 2 diabetes and ESRD will be compared with 20 matched patients with type 2 diabetes and normal kidney function in a randomised, parallel, placebo-controlled (1 : 1), double-blinded setting. All participants will receive 12 weeks of daily treatment with liraglutide/placebo in an individually titrated dose of 0.6, 1.2 or 1.8 mg. Over nine visits, plasma liraglutide, glycaemic control, β-cell response, cardiovascular parameters, various biomarkers and adverse events will be assessed. The primary endpoint will be evaluated from dose-corrected plasma trough liraglutide concentration at the final trial visit to determine potential accumulation in the ESRD group. Ethics and dissemination The study has been approved by the Danish Medicines Agency, the Scientific-Ethical Committee of the Capital Region of Denmark and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the study. The results of the study will be presented at national and international scientific meetings, and publications will be submitted to peer-reviewed journals. Trial registration ClinicalTrials.gov Identifier: NCT01394341 PMID:23624993

  10. Effect of traditional Chinese exercise on the quality of life and depression for chronic diseases: a meta-analysis of randomised trials

    PubMed Central

    Wang, Xueqiang; Pi, Yanling; Chen, Binglin; Chen, Peijie; Liu, Yu; Wang, Ru; Li, Xin; Zhu, Yi; Yang, Yujie; Niu, Zhanbin

    2015-01-01

    Traditional Chinese exercise (TCE) has many uses in the prevention and treatment of chronic diseases. However, there is no consensus regarding the benefit of TCE for chronic diseases. Our objective is to examine the effect of TCE on the quality of life and depression for chronic diseases by performing a meta-analysis of randomized controlled trials (RCTs). We only cover published RCTs. The outcome measures included quality of life and depression. Sixty articles with a total of 4311 patients were included. The pooling revealed that TCE could improve the SF-36 physical function subscale in the short term [SMD (95% CI) = 0.35 (0.13, 0.56), P = 0.002] and mid-term [SMD (95% CI) = 0.49 (0.12, 0.85), P = 0.009], GHQ [SMD (95% CI) = −0.68 (−1.26, −0.09), P = 0.02], the Center for Epidemiologic Studies depression scale in the short term [SMD (95% CI) = −0.86 (−1.42, −0.31), P = 0.002] and mid-term [SMD (95% CI) = −0.41 (−0.64, −0.18), P < 0.001]. The meta-analysis of RCT demonstrates that TCE can significantly improve the quality of life and depression of patients with chronic diseases. These findings provide useful information for patients with chronic diseases as well as for medical staff. PMID:26525282

  11. Murine Cervical Heart Transplantation Model Using a Modified Cuff Technique

    PubMed Central

    Kofler, Markus; Ritschl, Paul; Oellinger, Robert; Aigner, Felix; Sucher, Robert; Schneeberger, Stefan; Pratschke, Johann; Brandacher, Gerald; Maglione, Manuel

    2014-01-01

    Mouse models are of special interest in research since a wide variety of monoclonal antibodies and commercially defined inbred and knockout strains are available to perform mechanistic in vivo studies. While heart transplantation models using a suture technique were first successfully developed in rats, the translation into an equally widespread used murine equivalent was never achieved due the technical complexity of the microsurgical procedure. In contrast, non-suture cuff techniques, also developed initially in rats, were successfully adapted for use in mice1-3. This technique for revascularization involves two major steps I) everting the recipient vessel over a polyethylene cuff; II) pulling the donor vessel over the formerly everted recipient vessel and holding it in place with a circumferential tie. This ensures a continuity of the endothelial layer, short operating time and very high patency rates4. Using this technique for vascular anastomosis we performed more than 1,000 cervical heart transplants with an overall success rate of 95%. For arterial inflow the common carotid artery and the proximal aortic arch were anastomosed resulting in a retrograde perfusion of the transplanted heart. For venous drainage the pulmonary artery of the graft was anastomosed with the external jugular vein of the recipient5. Herein, we provide additional details of this technique to supplement the video. PMID:25350682

  12. Prognostic factors for clinical outcomes after rotator cuff repair

    PubMed Central

    Pécora, José Otávio Reggi; Malavolta, Eduardo Angeli; Assunção, Jorge Henrique; Gracitelli, Mauro Emílio Conforto; Martins, João Paulo Sobreiro; Ferreira, Arnaldo Amado

    2015-01-01

    OBJECTIVE: To identify prognostic factors of postoperative functional outcomes. METHODS: Retrospective case series evaluating patients undergoing rotator cuff repair, analyzed by the UCLA score (pre and 12-month postoperative) and Magnetic Resonance Imaging (preoperative). Patients' intrinsic variables related to the injury and intervention were evaluated. Multivariate linear regression analysis was performed to determine variables impact on postoperative functional assessment. RESULTS: 131 patients were included. The mean UCLA score increased from 13.17 ± 3.77 to 28.73 ± 6.09 (p<0,001). We obtained 65.7% of good and excellent results. Age (r= 0.232, p= 0.004) and reparability of posterosuperior injuries (r= 0.151, p= 0.043) correlated with the functional assessment at 12 months. After multivariate linear regression analysis, only age was associated (p = 0.008). CONCLUSIONS: The surgical treatment of rotator cuff tears lead to good and excellent results in 65.6% of patients. Age was an independent predictor factor with better clinical outcomes by UCLA score in older patients. Level of Evidence IV, Case Series. PMID:26207092

  13. Rotator cuff injuries in baseball. Prevention and rehabilitation.

    PubMed

    Jobe, F W; Bradley, J P

    1988-12-01

    Rotator cuff and ligamentous capsule injuries are common in the young baseball player. In order to understand these injuries, it is important to first appreciate the delicate balance between shoulder mobility and stability as well as the biomechanics of throwing. This background information makes it easy to see how shoulder injuries are really part of a progressive continuum beginning with instability leading to subluxation, and later impingement which can result in a rotator cuff tear. A detailed and precise history and physical is crucial in determining where a patient might be on the continuum. An accurate evaluation will also help appropriately place a patient in one of the following 4 groups: pure impingement, anterior instability due to trauma with secondary impingement, anterior stability due to a hyperelasticity with secondary impingement, and pure anterior instability. A kinesiological repair is the initial treatment of choice. It is the best preventative or early treatment available, and consists of a specific strengthening programme. If this fails (as in only 5 to 10% of the cases), an anatomical repair is instituted. There are 4 basic guidelines when doing this surgery: (a) maintain muscle attachments and proprioceptive fibres; (b) do not shorten the capsule significantly; (c) build up the anterior labrum; and (d) regain full range of motion quickly through abduction splinting and rehabilitation. A postoperative rehabilitation programme is then diligently adhered to, as it is at least as important as the surgery itself.

  14. Surgical treatment of tears of the rotator cuff in athletes.

    PubMed

    Tibone, J E; Elrod, B; Jobe, F W; Kerlan, R K; Carter, V S; Shields, C L; Lombardo, S J; Yocum, L

    1986-07-01

    Forty-five athletes with either a partial or a complete tear of the rotator cuff were treated with anterior acromioplasty and repair of the tear. The minimum duration of follow-up was twenty-four months (average, forty-two months). Thirty patients had an incomplete tear and fifteen had a complete tear. Postoperatively, thirty-nine (87 per cent) of the patients stated that they were improved compared with their preoperative status, although only thirty-four patients (76 per cent) felt that they had a significant reduction of pain postoperatively. Objectively, twenty-five (56 per cent) of the patients were rated as having a good result, which allowed them to return to their former competitive level without significant pain. Twelve (41 per cent) of the twenty-nine athletes who had been involved in pitching and throwing returned to their former competitive status. Seven (32 per cent) of the twenty-two pitchers and throwers who had been active at a professional or collegiate level returned to the same competitive level. In our experience, a repair of the rotator cuff combined with an acromioplasty in a young athletic population provides satisfactory relief of pain but does not guarantee that the patient will be able to return to his or her former competitive status in all sports.

  15. Revision Rotator Cuff Reconstruction for Large Tears With Retraction: A Novel Technique Using Autogenous Tendon and Autologous Marrow.

    PubMed

    Skoff, Hillel D

    2015-07-01

    Revision rotator cuff reconstruction for large tears with retraction results in a high rate of recurrent cuff tearing. To try to obtain more consistent results, I conducted a study of a technique that addresses the potential factors involved. Ten patients (7 men, 3 women) were enrolled. Mean age was 58 years. Mean follow-up was 24 months. Mean time between primary and revision cuff surgery was 36 months. The cardinal inclusion criterion was a symptomatic, full-thickness rotator cuff tear with at least 3 cm of retraction in a shoulder that previously underwent rotator cuff repair. Ultrasound was used for postoperative radiographic assessment of cuff integrity. Validated Constant, American Shoulder and Elbow Surgeons (ASES), and University of California Los Angeles (UCLA) shoulder scoring systems were used. Surgical technique included mini-open incision, adequate débridement and mobilization of remaining cuff, reconstitution of cuff defect with autogenous biceps tendon incubated in concentrated autologous bone marrow, and sewing under zero tissue tension. Constant, ASES, and UCLA scores improved significantly (standard error at .001). Ultrasound revealed 0% incidence of full-thickness rotator cuff retearing. In patients with large recurrent retracted rotator cuff tears the technique presented in the current study consistently yields satisfactory clinical results and promotes rotator cuff tissue healing without full-thickness retearing.

  16. Propaq Neonatal monitor used with its own single- or with Critikon twin-hose cuffs: does it matter?.

    PubMed

    Amoore

    1997-12-01

    Some oscillometric non-invasive blood pressure (NIBP) monitors use twin-hose cuffs, whereas others use single-hose cuffs. The incompatibility hinders the transfer of patients from monitors using a single-hose cuff to monitors using twin-hose cuffs and vice versa. In particular, the Propaq Encore uses a single-hose cuff, whereas the Critikon Dinamap uses a twin-hose single-bladder cuff. To facilitate the transfer of neonatal patients between the two monitors, we evaluated whether we could use the Propaq monitor with a Critikon dual-hose cuff connected via a 'Y' piece adaptor to the single lumen hose of the Propaq, rather than using the Propaq's own single-hose cuff. Using an NIBP test simulator, we compared the pressures recorded by the Propaq with the two cuff types over a range of pressures (from 60/30 to 120/80 mmHg), pulse rates (40-240 bpm) and pulse strengths (down to 10% of nominal). The differences between the results recorded with the two cuffs were very small and smaller than the differences between the Propaq and the Critikon. The results suggest that the measurements of pressure with the Propaq are not affected by the use of either a single- or a twin-hose cuff. Users need to be aware that different NIBP monitors may give different pressure readings.

  17. The role of post-operative radiotherapy in non-small-cell lung cancer: a multicentre randomised trial in patients with pathologically staged T1-2, N1-2, M0 disease. Medical Research Council Lung Cancer Working Party.

    PubMed Central

    Stephens, R. J.; Girling, D. J.; Bleehen, N. M.; Moghissi, K.; Yosef, H. M.; Machin, D.

    1996-01-01

    The role of post-operative radiotherapy for patients with non-small-cell lung cancer (NSCLC) is unclear despite five previous randomised trials. One deficiency with these trials was that they did not include adequate TNM staging, and so the present randomised trial was designed to compare surgery alone (S) with surgery plus post-operative radiotherapy (SR) in patients with pathologically staged T1-2, N1-2. M0 NSCLC. Between July 1986 and October 1993, 308 patients (154 S, 154 SR) were entered from 16 centres in the UK. The median age of the patients was 62 years, 74% were male, > 85% had normal or near normal levels of general condition, activity and breathlessness, 68% had squamous carcinoma, 52% had had a pneumonectomy, 63% had N1 disease and 37% N2 disease. SR patients received 40 Gy in 15 fractions starting 4-6 weeks post-operatively. Overall there was no advantage to either group in terms of survival, although definite local recurrence and bony metastases appeared less frequently and later in the SR group. In a subgroup analysis, in the N1 group no differences between the treatment groups were seen, but in the N2 group SR patients appeared to gain a one month survival advantage, delayed time to local recurrence and time to appearance of the bone metastases. There is, therefore, no clear indication for post-operative radiotherapy in N1 disease, but the question remains unresolved in N2 disease. PMID:8761382

  18. Arthroscopic technique for patch augmentation of rotator cuff repairs.

    PubMed

    Labbé, Marc R

    2006-10-01

    The patient is placed in the lateral position, and an arthroscopic cuff repair is performed according to standard techniques. The line of repair is usually in the shape of a "T" or an "L." The repair is viewed through the lateral portal, with fluid inflow through the scope. Mattress sutures are placed in the anterior and posterior portions of the cuff, with respect to the line of repair, just medial to the most medial point of the tear. The sutures are placed in accordance with margin convergence suture passing methods. Next, 2 double-stranded suture anchors are placed into the lateral aspect of the greater tuberosity, which can be used to secure the anterior and posterior portions of the rotator cuff as well as the patch. The cuff sutures are tied first; then, the patch is addressed. The graft is sized by placement of a ruled probe or similar device into the subacromial space. The length of each side of the "rectangle" is measured to obtain the dimensions of the patch. The patch is then cut to fit the measurements. If the patch material is elastic, a slightly smaller than measured graft is cut to provide tension on the repair. The arthroscope is then moved to the posterior portal, and a large (8 mm) cannula, with a dam, is placed into the lateral portal. All sutures are brought out of the lateral cannula, and corresponding ends of each suture are held together in a clamp. The sutures are placed in their respective orientations once outside the cannula (e.g., anterior-medial, anterior-lateral), covering all 4 quadrants. Care is taken to ensure that the sutures have no twists and are not wrapped around one another. The sutures are passed through the graft, in mattress fashion, with a free needle, in their respective corners and clamped again. The graft is then grasped with a small locking grasper on its medial edge and is passed through the cannula into the subacromial space. The clamps holding the sutures are then gently pulled to remove the slack. A smaller (5 mm

  19. Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease

    PubMed Central

    2012-01-01

    Background We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD) and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids. Results This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA) in l'Hospitalet de Llobregat (Barcelona) and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl), cholesterol < 250 mg/dl, 218 of whom received a more intensive intervention consisting of advice on lifestyle and treatment. The follow-up frequency of the intervention group was every 2 months. The other 218 patients followed their standard care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed. The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index. Conclusion Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol. Trial Registration ClinicalTrials.gov: NCT01089530 PMID:22381072

  20. Influence of rotator cuff tears on glenohumeral stability during abduction tasks.

    PubMed

    Hölscher, Thomas; Weber, Tim; Lazarev, Igor; Englert, Carsten; Dendorfer, Sebastian

    2016-09-01

    One of the main goals in reconstructing rotator cuff tears is the restoration of glenohumeral joint stability, which is subsequently of utmost importance in order to prevent degenerative damage such as superior labral anterior posterior (SLAP) lesion, arthrosis, and malfunction. The goal of the current study was to facilitate musculoskeletal models in order to estimate glenohumeral instability introduced by muscle weakness due to cuff lesions. Inverse dynamics simulations were used to compute joint reaction forces for several static abduction tasks with different muscle weakness. Results were compared with the existing literature in order to ensure the model validity. Further arm positions taken from activities of daily living, requiring the rotator cuff muscles were modeled and their contribution to joint kinetics computed. Weakness of the superior rotator cuff muscles (supraspinatus; infraspinatus) leads to a deviation of the joint reaction force to the cranial dorsal rim of the glenoid. Massive rotator cuff defects showed higher potential for glenohumeral instability in contrast to single muscle ruptures. The teres minor muscle seems to substitute lost joint torque during several simulated muscle tears to maintain joint stability. Joint instability increases with cuff tear size. Weakness of the upper part of the rotator cuff leads to a joint reaction force closer to the upper glenoid rim. This indicates the comorbidity of cuff tears with SLAP lesions. The teres minor is crucial for maintaining joint stability in case of massive cuff defects and should be uprated in clinical decision-making. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:1628-1635, 2016. PMID:26756861

  1. Tracheomegaly Secondary to Tracheotomy Tube Cuff in Amyotrophic Lateral Sclerosis: A Case Report.

    PubMed

    Lee, Dong Hoon; Yoon, Tae Mi; Lee, Joon Kyoo; Lim, Sang Chul

    2015-10-01

    Tracheomegaly has not been reported in amyotrophic lateral sclerosis (ALS). Herein, the authors report a case of tracheomegaly secondary to tracheotomy tube cuff in a patient with ALS. To our knowledge, this is the first report of an ALS patient with tracheomegaly and of tracheomegaly being associated with tracheotomy tube cuff and home tracheotomy mechanical ventilator.The clinician should consider the possibility of tracheomegaly in the differential diagnosis, if a patient with ALS develops repeat air leakage around the tracheotomy tube or rupture of tracheotomy tube cuff. PMID:26496301

  2. Acromio-clavicular joint cyst associated with a complete rotator cuff tear - a case report.

    PubMed

    McCreesh, Karen M; Riley, Sara J; Crotty, James M

    2014-10-01

    This case report describes a patient with an acromio-clavicular joint (ACJ) cyst, associated with a complete tear of the supraspinatus tendon, and the related arthropathy. Ultrasound was a suitable imaging modality to make the diagnosis, and rule out other pathologies. Full assessment of the rotator cuff must be carried out in the presence of ACJ cysts due to their common co-existence with large cuff tears. Cyst aspiration is not a suitable treatment, due to the high likelihood of recurrence. Optimal treatment requires management of the underlying rotator cuff tear.

  3. Review article: Risk factors for poor outcome following surgical treatment for rotator cuff tear.

    PubMed

    Sahni, V; Narang, A M

    2016-08-01

    The Medline database was searched using key words: 'rotator cuff', 'tear', and 'treatment'. 12 studies that involved (1) surgical treatment for rotator cuff tear, (2) measurement of pre- and post-operative pain score, functional score, and/or patient satisfaction, (3) patients that failed to improve functionally or had poor satisfaction, (4) preoperative examination of risk factors that could lead to poor outcome, and (5) a minimum follow-up of 6 months were reviewed to identify risk factors associated with poor outcome following surgical treatment for rotator cuff tear. The most common risk factor was tear size, followed by open compensation claim, age, and time from injury to surgery. PMID:27574276

  4. Strategies to improve retention in randomised trials

    PubMed Central

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These

  5. Ground reaction forces are more sensitive gait measures than temporal parameters in rodents following rotator cuff injury.

    PubMed

    Pardes, A M; Freedman, B R; Soslowsky, L J

    2016-02-01

    Gait analysis is a quantitative, non-invasive technique that can be used to investigate functional changes in animal models of musculoskeletal disease. Changes in ground reaction forces following injury have been observed that coincide with differences in tissue mechanical and histological properties during healing. However, measurement of these kinetic gait parameters can be laborious compared to the simpler and less time-consuming analysis of temporal gait parameters alone. We compared the sensitivity of temporal and kinetic gait parameters in detecting functional changes following rotator cuff injury in rats. Although these parameters were strongly correlated, temporal measures were unable to detect greater than 50% of the functional gait differences between injured and uninjured animals identified simultaneously by ground reaction forces. Regression analysis was used to predict ground reaction forces from temporal parameters. This model improved the ability of temporal parameters to identify known functional changes, but only when these differences were large in magnitude (i.e., between injured vs. uninjured animals, but not between different post-operative treatments). The results of this study suggest that ground reaction forces are more sensitive measures of limb/joint function than temporal parameters following rotator cuff injury in rats. Therefore, although gait analysis systems without force plates are typically efficient and easy to use, they may be most appropriate for use when major functional changes are expected. PMID:26768230

  6. Labrum and rotator cuff injuries in the throwing athlete.

    PubMed

    Menge, Travis J; Byram, Ian R; Boykin, Robert E; Bushnell, Brandon D

    2015-02-01

    The large amount of force imparted across the shoulder during the act of throwing makes the glenohumeral joint highly susceptible to injury in the athlete performing overhead throwing motions. The bony incongruity of the shoulder enables greater range of motion than any other joint in the body, but it also results in significant strain on the surrounding soft tissues during the throwing motion. Throwers can present with acute injuries, but more commonly they suffer from chronic overuse conditions resulting from repetitive overload. Proper management requires early recognition with treatment directed toward the athlete's safe return to sports. Failure to institute an appropriate management strategy may result in significant complications, including prolonged disability, progression of symptoms, and further injury. We discuss the functional anatomy, pathophysiology, clinical presentation, evaluation, and treatment of common injuries of the glenoid labrum and rotator cuff in the overhead throwing athlete. PMID:25599876

  7. Repair Integrity and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

    PubMed Central

    Williams, Ariel A.; Mark, P.; DiVenere, Jessica Megan; Klinge, Stephen Austin; Arciero, Robert A.; Mazzocca, Augustus D.

    2016-01-01

    Objectives: To prospectively evaluate the effect of early versus delayed motion on repair integrity on 6-month postoperative magnetic resonance imaging (MRI) scans following rotator cuff repair, and to correlate repair integrity with clinical and functional outcomes. We hypothesized that repair integrity would differ between the early and delayed groups and that patients with repair failures would have worse clinical and functional outcomes. Methods: This was a prospective, randomized, single blinded clinical trial comparing an early motion (post-op day 2-3) to a delayed motion (post-op day 28) rehabilitation protocol following arthroscopic repair of isolated supraspinatus tears. All patients underwent MRI at 6 months post-operatively as part of the study protocol. A blinded board-certified and fellowship-trained orthopaedic surgeon (not part of the surgical team) reviewed operative photos and video to confirm the presence of a full thickness supraspinatus tear and to ensure an adequate and consistent repair. The same surgeon along with a blinded sports medicine fellowship-trained musculoskeletal radiologist independently reviewed all MRIs to determine whether the repair was intact at 6 months. Outcome measures were collected by independent evaluators who were also blinded to group assignment. These included the Western Ontario Rotator Cuff (WORC) index, Single Assessment Numeric Evaluation (SANE) ratings, pain scores, sling use, and physical exam data. Enrolled patients were followed at 6 weeks, 6 months, and 1 year. Results: From October 2008 to April 2012, 73 patients met all inclusion criteria and were willing to participate. 36 patients were randomized to delayed motion and 37 were randomized to early motion. The final study group at 6 months consisted of 58 study participants. Postoperative MRIs were obtained on all of these patients at 6 months regardless of whether or not they were progressing as expected. These MRIs demonstrated an overall failure rate of

  8. Fascicle-selective multi-contact cuff electrode.

    PubMed

    Rossel, Olivier; Soulier, Fabien; Coulombe, Jonathan; Bernard, Serge; Cathébras, Guy

    2011-01-01

    Neural recording is one of the main issues to be addressed in order to allow closed-loop functional electrical stimulation systems. Because each fascicle in nerves carry specific information, new sensors providing high spatial selectivity are required for chronic implantable devices. This work aims at evaluating the feasibility of a new device using a highly spatial-selective multi-contact cuff electrode. The proposed electrode configuration is evaluated based on simulations using a model of a nerve comprising multiple fascicles. Study of the electrode selectivity is done and compared with a state-of-the-art electrode designed for the same purpose and shows that activity of two fascicles separated by as little as 1 mm can be distinguished. Implementation challenges and perspectives for such electrodes are also discussed.

  9. Fascicle-selective multi-contact cuff electrode.

    PubMed

    Rossel, Olivier; Soulier, Fabien; Coulombe, Jonathan; Bernard, Serge; Cathébras, Guy

    2011-01-01

    Neural recording is one of the main issues to be addressed in order to allow closed-loop functional electrical stimulation systems. Because each fascicle in nerves carry specific information, new sensors providing high spatial selectivity are required for chronic implantable devices. This work aims at evaluating the feasibility of a new device using a highly spatial-selective multi-contact cuff electrode. The proposed electrode configuration is evaluated based on simulations using a model of a nerve comprising multiple fascicles. Study of the electrode selectivity is done and compared with a state-of-the-art electrode designed for the same purpose and shows that activity of two fascicles separated by as little as 1 mm can be distinguished. Implementation challenges and perspectives for such electrodes are also discussed. PMID:22254969

  10. Exploring the variation in implementation of a COPD disease management programme and its impact on health outcomes: a post hoc analysis of the RECODE cluster randomised trial

    PubMed Central

    Boland, Melinde R S; Kruis, Annemarije L; Huygens, Simone A; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

    2015-01-01

    This study aims to (1) examine the variation in implementation of a 2-year chronic obstructive pulmonary disease (COPD) management programme called RECODE, (2) analyse the facilitators and barriers to implementation and (3) investigate the influence of this variation on health outcomes. Implementation variation among the 20 primary-care teams was measured directly using a self-developed scale and indirectly through the level of care integration as measured with the Patient Assessment of Chronic Illness Care (PACIC) and the Assessment of Chronic Illness Care (ACIC). Interviews were held to obtain detailed information regarding the facilitators and barriers to implementation. Multilevel models were used to investigate the association between variation in implementation and change in outcomes. The teams implemented, on average, eight of the 19 interventions, and the specific package of interventions varied widely. Important barriers and facilitators of implementation were (in)sufficient motivation of healthcare provider and patient, the high starting level of COPD care, the small size of the COPD population per team, the mild COPD population, practicalities of the information and communication technology (ICT) system, and hurdles in reimbursement. Level of implementation as measured with our own scale and the ACIC was not associated with health outcomes. A higher level of implementation measured with the PACIC was positively associated with improved self-management capabilities, but this association was not found for other outcomes. There was a wide variety in the implementation of RECODE, associated with barriers at individual, social, organisational and societal level. There was little association between extent of implementation and health outcomes. PMID:26677770

  11. Exploring the variation in implementation of a COPD disease management programme and its impact on health outcomes: a post hoc analysis of the RECODE cluster randomised trial.

    PubMed

    Boland, Melinde R S; Kruis, Annemarije L; Huygens, Simone A; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

    2015-01-01

    This study aims to (1) examine the variation in implementation of a 2-year chronic obstructive pulmonary disease (COPD) management programme called RECODE, (2) analyse the facilitators and barriers to implementation and (3) investigate the influence of this variation on health outcomes. Implementation variation among the 20 primary-care teams was measured directly using a self-developed scale and indirectly through the level of care integration as measured with the Patient Assessment of Chronic Illness Care (PACIC) and the Assessment of Chronic Illness Care (ACIC). Interviews were held to obtain detailed information regarding the facilitators and barriers to implementation. Multilevel models were used to investigate the association between variation in implementation and change in outcomes. The teams implemented, on average, eight of the 19 interventions, and the specific package of interventions varied widely. Important barriers and facilitators of implementation were (in)sufficient motivation of healthcare provider and patient, the high starting level of COPD care, the small size of the COPD population per team, the mild COPD population, practicalities of the information and communication technology (ICT) system, and hurdles in reimbursement. Level of implementation as measured with our own scale and the ACIC was not associated with health outcomes. A higher level of implementation measured with the PACIC was positively associated with improved self-management capabilities, but this association was not found for other outcomes. There was a wide variety in the implementation of RECODE, associated with barriers at individual, social, organisational and societal level. There was little association between extent of implementation and health outcomes. PMID:26677770

  12. Exploring the variation in implementation of a COPD disease management programme and its impact on health outcomes: a post hoc analysis of the RECODE cluster randomised trial.

    PubMed

    Boland, Melinde R S; Kruis, Annemarije L; Huygens, Simone A; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

    2015-12-17

    This study aims to (1) examine the variation in implementation of a 2-year chronic obstructive pulmonary disease (COPD) management programme called RECODE, (2) analyse the facilitators and barriers to implementation and (3) investigate the influence of this variation on health outcomes. Implementation variation among the 20 primary-care teams was measured directly using a self-developed scale and indirectly through the level of care integration as measured with the Patient Assessment of Chronic Illness Care (PACIC) and the Assessment of Chronic Illness Care (ACIC). Interviews were held to obtain detailed information regarding the facilitators and barriers to implementation. Multilevel models were used to investigate the association between variation in implementation and change in outcomes. The teams implemented, on average, eight of the 19 interventions, and the specific package of interventions varied widely. Important barriers and facilitators of implementation were (in)sufficient motivation of healthcare provider and patient, the high starting level of COPD care, the small size of the COPD population per team, the mild COPD population, practicalities of the information and communication technology (ICT) system, and hurdles in reimbursement. Level of implementation as measured with our own scale and the ACIC was not associated with health outcomes. A higher level of implementation measured with the PACIC was positively associated with improved self-management capabilities, but this association was not found for other outcomes. There was a wide variety in the implementation of RECODE, associated with barriers at individual, social, organisational and societal level. There was little association between extent of implementation and health outcomes.

  13. Influence of intermittent compression cuff design on interface pressure and calf deformation: experimental results.

    PubMed

    John, Gareth W; Narracott, Andrew J; Morris, Rhys J; Woodcock, John P; Lawford, Patricia V; Hose, D Rodney

    2007-01-01

    Intermittent pneumatic compression (IPC) is widely used for deep vein thrombosis (DVT) prophylaxis. The technique involves periodic inflation of a compression cuff around a limb, which acts to simulate the muscle pump mechanism, encouraging venous blood flow. However, there is uncertainty regarding the relationship between compression, vascular effects and clinical outcomes. This study investigates calf compression provided by four IPC cuffs with different air bladder configurations. Interface pressure between the cuff and the skin surface is measured and magnetic resonance (MR) images are obtained showing the calf cross section before and during compression. The data will be used to inform numerical simulations of IPC, leading to increased understanding of the implications of cuff design in relation to IPC and DVT prophylaxis.

  14. Arthroscopic Double-Row Transosseous Equivalent Rotator Cuff Repair with a Knotless Self-Reinforcing Technique

    PubMed Central

    Mook, William R.; Greenspoon, Joshua A.; Millett, Peter J.

    2016-01-01

    Background: Rotator cuff tears are a significant cause of shoulder morbidity. Surgical techniques for repair have evolved to optimize the biologic and mechanical variables critical to tendon healing. Double-row repairs have demonstrated superior biomechanical advantages to a single-row. Methods: The preferred technique for rotator cuff repair of the senior author was reviewed and described in a step by step fashion. The final construct is a knotless double row transosseous equivalent construct. Results: The described technique includes the advantages of a double-row construct while also offering self reinforcement, decreased risk of suture cut through, decreased risk of medial row overtensioning and tissue strangulation, improved vascularity, the efficiency of a knotless system, and no increased risk for subacromial impingement from the burden of suture knots. Conclusion: Arthroscopic knotless double row rotator cuff repair is a safe and effective method to repair rotator cuff tears. PMID:27733881

  15. A protocol design for evaluation of wearable cuff-less blood pressure measuring devices.

    PubMed

    Yan, Iris R F; Poon, Carmen C Y; Zhang, Y T

    2009-01-01

    This paper proposes one of the unique requirements in the validation protocol of the IEEE P1708 standard in assessing wearable cuff-less blood pressure (BP) measuring devices. Based on principles that are different from that of the conventional cuff-based devices, the cuff-less BP measurement approaches often require an individual calibration procedure. In this study, we used data from an experiment carried out on 28 subjects with a total of 139 sets of BP measurements as an example to show that breakdown of the performance evaluation of cuff-less devices according to the change of BP from the point of calibration is crucial for understanding and interpreting the overall accuracy of the device. PMID:19964197

  16. Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial

    PubMed Central

    Trent, Maria; Chung, Shang-en; Gaydos, Charlotte; Frick, Kevin D.; Anders, Jennifer; Huettner, Steven; Rothman, Richard; Butz, Arlene

    2016-01-01

    Purpose Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused on strategies to improve outpatient adherence or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community-health nursing (TECH-N) intervention among urban AYA with PID. Methods AYA women aged 13–25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing performed at the 30-and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. Results In the first 48 months, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been within the 5-day window and over 90% of patients in both arms have been retained over the 3

  17. The UPBEAT Nurse-Delivered Personalized Care Intervention for People with Coronary Heart Disease Who Report Current Chest Pain and Depression: A Randomised Controlled Pilot Study

    PubMed Central

    Barley, Elizabeth A.; Walters, Paul; Haddad, Mark; Phillips, Rachel; Achilla, Evanthia; McCrone, Paul; Van Marwijk, Harm; Mann, Anthony; Tylee, Andre

    2014-01-01

    Background Depression is common in people with coronary heart disease (CHD) and associated with worse outcome. This study explored the acceptability and feasibility of procedures for a trial and for an intervention, including its potential costs, to inform a definitive randomized controlled trial (RCT) of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression. Methods Multi-centre, outcome assessor-blinded, randomized parallel group study. CHD patients reporting chest pain and scoring 8 or more on the HADS were randomized to personalized care (PC) or treatment as usual (TAU) for 6 months and followed for 1 year. Primary outcome was acceptability and feasibility of procedures; secondary outcomes included mood, chest pain, functional status, well being and psychological process variables. Result 1001 people from 17 General Practice CHD registers in South London consented to be contacted; out of 126 who were potentially eligible, 81 (35% female, mean age = 65 SD11 years) were randomized. PC participants (n = 41) identified wide ranging problems to work on with nurse-case managers. Good acceptability and feasibility was indicated by low attrition (9%), high engagement and minimal nurse time used (mean/SD = 78/19 mins assessment, 125/91 mins telephone follow up). Both groups improved on all outcomes. The largest between group difference was in the proportion no longer reporting chest pain (PC 37% vs TAU 18%; mixed effects model OR 2.21 95% CI 0.69, 7.03). Some evidence was seen that self efficacy (mean scale increase of 2.5 vs 0.9) and illness perceptions (mean scale increase of 7.8 vs 2.5) had improved in PC vs TAU participants at 1 year. PC appeared to be more cost effective up to a QALY threshold of approximately £3,000. Conclusions Trial and intervention procedures appeared to be feasible and acceptable. PC allowed patients to work on unaddressed problems and appears cheaper than TAU

  18. Recruitment of Minority Adolescents and Young Adults into Randomised Clinical Trials: Testing the Design of the Technology Enhanced Community Health Nursing (TECH-N) Pelvic Inflammatory Disease Trial

    PubMed Central

    Trent, Maria; Chung, Shang-en; Gaydos, Charlotte; Frick, Kevin D.; Anders, Jennifer; Huettner, Steven; Rothman, Richard; Butz, Arlene

    2016-01-01

    Purpose Pelvic inflammatory disease (PID) disproportionately affects adolescent and young adult (AYA) women and can negatively influence reproductive health trajectories. Few randomized controlled trials (RCTs) have focused on strategies to improve outpatient adherence or to reduce reproductive morbidity in this population. This paper describes the research methods and preliminary effectiveness of recruitment, retention, and intervention strategies employed in a novel RCT designed to test a technology-enhanced community-health nursing (TECH-N) intervention among urban AYA with PID. Methods AYA women aged 13–25 years were recruited during acute PID visits in outpatient clinics and emergency departments (ED) to participate in this IRB-approved trial. Participants completed an audio-computerized self-interview (ACASI), provided vaginal specimens, and were randomized to standard treatment or the intervention. Intervention participants received text-messaging support for 30 days and a community health nurse (CHN) interventionist performed a home visit with clinical assessment within 5 days after enrollment. All patients received a full course of medications and completed research visits at 14-days (adherence), 30 days and 90 days with by an outreach worker. STI testing performed at the 30-and 90-day visits. Exploratory analyses using descriptive statistics were conducted to examine recruitment, retention, and follow-up data to test the overall design of the intervention. Results In the first 48 months, 64% of 463 patients were eligible for the study and 81.2% of 293 eligible patients were recruited for the study (63.3%); 238 (81.2%) of eligible patients were enrolled. Most participants were African American (95.6%) with a mean age of 18.6 (2.3). Ninety-four percent of individuals assigned to the TECH-N intervention completed the nursing visits. All completed visits have been within the 5-day window and over 90% of patients in both arms have been retained over the 3

  19. Adding liraglutide to the backbone therapy of biguanide in patients with coronary artery disease and newly diagnosed type-2 diabetes (the AddHope2 study): a randomised controlled study protocol

    PubMed Central

    Anholm, Christian; Kumarathurai, Preman; Klit, Malene S; Kristiansen, Ole P; Nielsen, Olav W; Ladelund, Steen; Madsbad, Sten; Sajadieh, Ahmad; Haugaard, Steen B

    2014-01-01

    Introduction Newly diagnosed type 2 diabetes mellitus (T2DM) in patients with coronary artery disease (CAD) more than doubles the risk of death compared with otherwise matched glucose tolerant patients. The biguanide metformin is the drug of choice in treatment of T2DM and has shown to ameliorate cardiovascular morbidity in patients with T2DM and myocardial infarction (MI). The incretin hormone, glucagon-like peptide-1 (GLP-1) improves β-cell function, insulin sensitivity and causes weight loss and has been suggested to have beneficial effects on cardiac function. The GLP-1 receptor agonist (GLP-1RA), liraglutide, is currently used for treatment of T2DM but its potential effect on cardiac function has not been investigated in detail. We hypothesised that liraglutide added to metformin backbone therapy in patients with CAD and newly diagnosed T2DM will improve β-cell function and left ventricular systolic function during dobutamine stress. Methods and analyses 40 patients with CAD and newly diagnosed T2DM will receive the intervention liraglutide+metformin and placebo+metformin in this investigator-initiated, double blind, randomised, placebo-controlled, cross-over 12 plus 12 weeks intervention study with a 2-week washout period. The primary cardiovascular end point is changes in left ventricular ejection fraction during stress echocardiography. The primary endocrine end point is β-cell function evaluated during a frequently sampled intravenous glucose tolerance test. Secondary end points include heart rate variability, diurnal blood pressure, glucagon suppression and inflammatory response (urine, blood and adipose tissue). Ethics and dissemination This study is approved by the Danish Medicines Agency, the Danish Dataprotection Agency and the Regional Committee on Biomedical Research Ethics of the Capital Region of Denmark. The trial will be carried out under the guidance from the GCP unit at Copenhagen University Hospital of Bispebjerg and in accordance with

  20. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials

    PubMed Central

    Cholesterol Treatment Trialists' (CTT) Collaborators

    2012-01-01

    Summary Background Statins reduce LDL cholesterol and prevent vascular events, but their net effects in people at low risk of vascular events remain uncertain. Methods This meta-analysis included individual participant data from 22 trials of statin versus control (n=134 537; mean LDL cholesterol difference 1·08 mmol/L; median follow-up 4·8 years) and five trials of more versus less statin (n=39 612; difference 0·51 mmol/L; 5·1 years). Major vascular events were major coronary events (ie, non-fatal myocardial infarction or coronary death), strokes, or coronary revascularisations. Participants were separated into five categories of baseline 5-year major vascular event risk on control therapy (no statin or low-intensity statin) (<5%, ≥5% to <10%, ≥10% to <20%, ≥20% to <30%, ≥30%); in each, the rate ratio (RR) per 1·0 mmol/L LDL cholesterol reduction was estimated. Findings Reduction of LDL cholesterol with a statin reduced the risk of major vascular events (RR 0·79, 95% CI 0·77–0·81, per 1·0 mmol/L reduction), largely irrespective of age, sex, baseline LDL cholesterol or previous vascular disease, and of vascular and all-cause mortality. The proportional reduction in major vascular events was at least as big in the two lowest risk categories as in the higher risk categories (RR per 1·0 mmol/L reduction from lowest to highest risk: 0·62 [99% CI 0·47–0·81], 0·69 [99% CI 0·60–0·79], 0·79 [99% CI 0·74–0·85], 0·81 [99% CI 0·77–0·86], and 0·79 [99% CI 0·74–0·84]; trend p=0·04), which reflected significant reductions in these two lowest risk categories in major coronary events (RR 0·57, 99% CI 0·36–0·89, p=0·0012, and 0·61, 99% CI 0·50–0·74, p<0·0001) and in coronary revascularisations (RR 0·52, 99% CI 0·35–0·75, and 0·63, 99% CI 0·51–0·79; both p<0·0001). For stroke, the reduction in risk in participants with 5-year risk of major vascular events lower than 10% (RR per 1·0 mmol/L LDL cholesterol

  1. Rotator cuff tears after total shoulder arthroplasty in primary osteoarthritis: A systematic review

    PubMed Central

    Levy, David M.; Abrams, Geoffrey D.; Harris, Joshua D.; Bach, Bernard R.; Nicholson, Gregory P.; Romeo, Anthony A.

    2016-01-01

    Rotator cuff tears have been reported to be uncommon following total shoulder arthroplasty (TSA). Postoperative rotator cuff tears can lead to pain, proximal humeral migration, and glenoid component loosening. The purpose of this paper was to evaluate the incidence of post-TSA rotator cuff tears or dysfunction in osteoarthritic patients. A systematic review of multiple databases was performed using preferred reporting items for systematic reviews and meta-analyses guidelines. Levels I-IV evidence clinical studies of patients with primary osteoarthritis with a minimum 2-year follow-up were included. Fifteen studies with 1259 patients (1338 shoulders) were selected. Student's t-tests were used with a significant alpha value of 0.05. All patients demonstrated significant improvements in motion and validated clinical outcome scores (P < 0.001). Radiographic humeral head migration was the most commonly reported data point for extrapolation of rotator cuff integrity. After 6.6 ± 3.1 years, 29.9 ± 20.7% of shoulders demonstrated superior humeral head migration and 17.9 ± 14.3% migrated a distance more than 25% of the head. This was associated with an 11.3 ± 7.9% incidence of postoperative superior cuff tears. The incidence of radiographic anterior humeral head migration was 11.9 ± 15.9%, corresponding to a 3.0 ± 13.6% rate of subscapularis tears. We found an overall 1.2 ± 4.5% rate of reoperation for cuff injury. Nearly all studies reported indirect markers of rotator cuff dysfunction, such as radiographic humeral head migration and clinical exam findings. This systematic review suggests that rotator cuff dysfunction following TSA may be more common than previously reported. IV, systematic review of Levels I-IV studies. PMID:27186060

  2. Diagnostic accuracy of clinical examination features for identifying large rotator cuff tears in primary health care

    PubMed Central

    Cadogan, Angela; McNair, Peter; Laslett, Mark; Hing, Wayne; Taylor, Stephen

    2013-01-01

    Objectives: Rotator cuff tears are a common and disabling complaint. The early diagnosis of medium and large size rotator cuff tears can enhance the prognosis of the patient. The aim of this study was to identify clinical features with the strongest ability to accurately predict the presence of a medium, large or multitendon (MLM) rotator cuff tear in a primary care cohort. Methods: Participants were consecutively recruited from primary health care practices (n = 203). All participants underwent a standardized history and physical examination, followed by a standardized X-ray series and diagnostic ultrasound scan. Clinical features associated with the presence of a MLM rotator cuff tear were identified (P<0.200), a logistic multiple regression model was derived for identifying a MLM rotator cuff tear and thereafter diagnostic accuracy was calculated. Results: A MLM rotator cuff tear was identified in 24 participants (11.8%). Constant pain and a painful arc in abduction were the strongest predictors of a MLM tear (adjusted odds ratio 3.04 and 13.97 respectively). Combinations of ten history and physical examination variables demonstrated highest levels of sensitivity when five or fewer were positive [100%, 95% confidence interval (CI): 0.86–1.00; negative likelihood ratio: 0.00, 95% CI: 0.00–0.28], and highest specificity when eight or more were positive (0.91, 95% CI: 0.86–0.95; positive likelihood ratio 4.66, 95% CI: 2.34–8.74). Discussion: Combinations of patient history and physical examination findings were able to accurately detect the presence of a MLM rotator cuff tear. These findings may aid the primary care clinician in more efficient and accurate identification of rotator cuff tears that may require further investigation or orthopedic consultation. PMID:24421626

  3. Telemetric Blood Pressure Assessment in Angiotensin II-Infused ApoE-/- Mice: 28 Day Natural History and Comparison to Tail-Cuff Measurements.

    PubMed

    Haggerty, Christopher M; Mattingly, Andrea C; Gong, Ming C; Su, Wen; Daugherty, Alan; Fornwalt, Brandon K

    2015-01-01

    Abdominal aortic aneurysm (AAA) is a disease of the aortic wall, which can progress to catastrophic rupture. Assessment of mechanical characteristics of AAA, such as aortic distensibility, may provide important insights to help identify at-risk patients and understand disease progression. While the majority of studies on this topic have focused on retrospective patient data, recent studies have used mouse models of AAA to prospectively evaluate the evolution of aortic mechanics. Quantification of aortic distensibility requires accurate measurement of arterial blood pressure, particularly pulse pressure, which is challenging to perform accurately in murine models. We hypothesized that volume/pressure tail-cuff measurements of arterial pulse pressure in anesthetized mice would have sufficient accuracy to enable calculations of aortic distensibility with minimal error. Telemetry devices and osmotic mini-pumps filled with saline or angiotensin-II were surgically implanted in male apolipoprotein-E deficient (ApoE(-/-)) mice. Blood pressure in the aortic arch was measured continuously via telemetry. In addition, simultaneous blood pressure measurements with a volume/pressure tail-cuff system were performed under anesthesia at specific intervals to assess agreement between techniques. Compared to controls, mice infused with angiotensin-II had an overall statistically significant increase in systolic pressure, with no overall difference in pulse pressure; however, pulse pressure did increase significantly with time. Systolic measurements agreed well between telemetry and tail-cuff (coefficient of variation = 10%), but agreement of pulse pressure was weak (20%). In fact, group-averaged pulse pressure from telemetry was a better predictor of a subject's pulse pressure on a given day than a simultaneous tail-cuff measurement. Furthermore, these approximations introduced acceptable errors (15.1 ± 12.8%) into the calculation of aortic distensibility. Contrary to our hypothesis

  4. Simple Arm Tourniquet as an Adjunct to Double-Cuff Tourniquet in Intravenous Regional Anesthesia

    PubMed Central

    Jafarian, Ali Akbar; Imani, Farnad; Salehi, Reza; Najd Mazaher, Farid; Moini, Fatemeh

    2016-01-01

    Background: Intravenous Regional Anesthesia (IVRA) is a well-known technique for producing analgesia during surgical procedures in the extremities. However, the rapid onset of pain following the deflation of a double-cuff tourniquet during IVRA is a serious disadvantage, leading patient suffering. Objectives: The aim of this study was to evaluate the clinical effectiveness of a pneumatic arm tourniquet applied 2 cm above the double-cuff tourniquet in controlling the pain that occurs after its deflation. Patients and Methods: Twenty patients undergoing outpatient hand surgery were operated on under IVRA, using 40 - 50 mL of a solution containing 3 mg/kg of lignocaine. A simple pneumatic tourniquet was applied proximal to the double-cuff tourniquet, 3 min before its deflation, while the procedure was being conducted. The severity of pain on the basis of the Numerical Rating Scale (NRS) was assessed throughout the operation, and continued until an hour after the double-cuff tourniquet was removed. Results: The mean operation time after the deflation of the double-cuff tourniquet was 20.12 ± 6.1 minutes. Moreover, the mean NRS for the post-deflation time was insignificant (NRS = 2), and only one patient during first 20 minutes received opioids. Conclusions: This study showed that a pneumatic arm tourniquet as an adjunct to IVRA provides acceptable analgesia following the deflation of the double- cuff tourniquet for relieving surgical pain. PMID:27635387

  5. Rehabilitation following rotator cuff repair: a survey of current UK practice

    PubMed Central

    Bateman, Marcus

    2015-01-01

    Background Rotator cuff disorders, including rotator cuff tears, are common and can be treated conservatively or surgically. Data suggest that the incidence of surgery to repair the rotator cuff is rising. Despite this rise, the most effective approach to postoperative rehabilitation, a critical component of the recovery process, is not well developed. The present study aimed to describe current practice in the UK in relation to rehabilitation following rotator cuff repair. Methods An electronic survey was developed and disseminated to UK based physiotherapists and surgeons involved with rotator cuff repair. Results One hundred valid responses were received. Although there is a degree of variation, current practice for the majority of respondents consists of sling immobilization for 4 weeks to 6 weeks. During this time, passive movement would be commenced before active movement is introduced towards the end of this phase. Resisted exercise begins 7 weeks to 12 weeks postoperatively, alongside return to light work. A progressive resumption of function, including manual work and sport, is advised from approximately 13 weeks. Conclusions In the context of the current literature, it might be suggested that the current approach to rehabilitation following rotator cuff repair for the majority of respondents is somewhat cautious and has not progressed for over a decade. PMID:27582979

  6. Sore throat after operation: influence of tracheal intubation, intracuff pressure and type of cuff.

    PubMed

    Jensen, P J; Hommelgaard, P; Søndergaard, P; Eriksen, S

    1982-04-01

    One hundred and eighty-four patients were studied to elucidate the contribution of intracuff pressure and cuff type to the occurrence of sore throat and hoarseness after operation. The patients were allocated to one of the following groups: A = mask only; B = reusable Rüsch tube with intermittent cuff volume adjustment; C = reusable Rüsch tube without cuff volume adjustment; D = disposable Portex Blue Line tube with intermittent cuff volume adjustment; E = disposable Shiley Low Pressure tube with intermittent cuff volume adjustment. Nitrous oxide was a component of anaesthesia in all patients. Moderate or severe symptoms were recorded in 30-33% of the patients in groups C, D and E, contrasting with group B, in which these sequelae were seen in only 10% of patients (P less than 0.025). All sequelae occurred less frequently in group A than in any of the other groups (P less than 0.025). Women were more likely to develop sore throat after intubation than were men (P less than 0.01). A possible relationship between differences in cuff-trachea contact area is postulated.

  7. Tissue Engineering for Rotator Cuff Repair: An Evidence-Based Systematic Review

    PubMed Central

    Maffulli, Nicola; Longo, Umile Giuseppe; Loppini, Mattia; Berton, Alessandra; Spiezia, Filippo; Denaro, Vincenzo

    2012-01-01

    The purpose of this systematic review was to address the treatment of rotator cuff tears by applying tissue engineering approaches to improve tendon healing, specifically platelet rich plasma (PRP) augmentation, stem cells, and scaffolds. Our systematic search was performed using the combination of the following terms: “rotator cuff”, “shoulder”, “PRP”, “platelet rich plasma”, “stemcells”, “scaffold”, “growth factors”, and “tissue engineering”. No level I or II studies were found on the use of scaffolds and stem cells for rotator cuff repair. Three studies compared rotator cuff repair with or without PRP augmentation. All authors performed arthroscopic rotator cuff repair with different techniques of suture anchor fixation and different PRP augmentation. The three studies found no difference in clinical rating scales and functional outcomes between PRP and control groups. Only one study showed clinical statistically significant difference between the two groups at the 3-month follow up. Any statistically significant difference in the rates of tendon rerupture between the control group and the PRP group was found using the magnetic resonance imaging. The current literature on tissue engineering application for rotator cuff repair is scanty. Comparative studies included in this review suggest that PRP augmented repair of a rotator cuff does not yield improved functional and clinical outcome compared with non-augmented repair at a medium and long-term followup. PMID:25098365

  8. Simple Arm Tourniquet as an Adjunct to Double-Cuff Tourniquet in Intravenous Regional Anesthesia

    PubMed Central

    Jafarian, Ali Akbar; Imani, Farnad; Salehi, Reza; Najd Mazaher, Farid; Moini, Fatemeh

    2016-01-01

    Background: Intravenous Regional Anesthesia (IVRA) is a well-known technique for producing analgesia during surgical procedures in the extremities. However, the rapid onset of pain following the deflation of a double-cuff tourniquet during IVRA is a serious disadvantage, leading patient suffering. Objectives: The aim of this study was to evaluate the clinical effectiveness of a pneumatic arm tourniquet applied 2 cm above the double-cuff tourniquet in controlling the pain that occurs after its deflation. Patients and Methods: Twenty patients undergoing outpatient hand surgery were operated on under IVRA, using 40 - 50 mL of a solution containing 3 mg/kg of lignocaine. A simple pneumatic tourniquet was applied proximal to the double-cuff tourniquet, 3 min before its deflation, while the procedure was being conducted. The severity of pain on the basis of the Numerical Rating Scale (NRS) was assessed throughout the operation, and continued until an hour after the double-cuff tourniquet was removed. Results: The mean operation time after the deflation of the double-cuff tourniquet was 20.12 ± 6.1 minutes. Moreover, the mean NRS for the post-deflation time was insignificant (NRS = 2), and only one patient during first 20 minutes received opioids. Conclusions: This study showed that a pneumatic arm tourniquet as an adjunct to IVRA provides acceptable analgesia following the deflation of the double- cuff tourniquet for relieving surgical pain.

  9. Teres Minor Hypertrophy is a Common and Negative Predictor of Outcomes after Rotator Cuff Repair

    PubMed Central

    Tokish, John M.; Thigpen, Charles A.; Kissenberth, Michael J.; Hunt, Quinn; Tolan, Stefan John; Swinehart, S. Dane; Shelley, Christina; Hawkins, Richard J.

    2016-01-01

    Objectives: The teres minor has received increased attention in its role as a rotator cuff muscle, particularly in the setting of large infraspinatus tears. Studies have shown that it plays an important beneficial role after total (TSA) and reverse (RSA) shoulder arthroplasty, as well as in maintenance of function in the setting of infraspinatus wasting in patients with large rotator cuff tears. No study, however, has investigated how often teres minor hypertrophy occurs in a population of rotator cuff tears, whether it occurs in the absence of infraspinatus tearing, or whether it is a positive or negative prognostic indicator on outcomes after rotator cuff repair. The purpose of this study was to determine the prevalence of teres minor hypertrophy in a cohort of patients undergoing rotator cuff repair, and to determine its prognostic effect, if any, on outcomes after surgical repair. Methods: Over a 3 year period, all rotator cuff repairs performed in a single practice by 3 American Shoulder and Elbow Society (ASES) member surgeons were collected. One hundered forty-four patients who had preoperative and postoperative (ASES) outcomes (minimum 2 year), and preoperative Magnetic Resonance Imaging (MRI) were included in the study. All MRIs were evaluated for rotator cuff tear tendon involvement, tear size, and Goutallier changes of each muscle. In addition, occupational ratios were determined for the supraspinatus, infraspinatus, and teres minor muscles. Patients were divided into 2 groups, based upon whether they had teres minor hypertrophy or not, based on a previously established definition. A 2 way univariate ANOVA was used to determine the effect of teres minor hypertrophy(tear size by hypertrophy) and Goutallier changes(tear size by fatty infiltration) on ASES change scores(α=0.05) Results: Teres minor hypertrophy was a relatively common finding in this cohort of rotator cuff patients, with 51% of all shoulders demonstrating hypertrophy. Interestingly, in

  10. SWIM (sickle with ibuprofen and morphine) randomised controlled trial fails to recruit: lessons learnt

    PubMed Central

    Cho, Gavin; Anie, Kofi A; Buckton, Jacky; Kiilu, Patricia; Layton, Mark; Alexander, Lydia; Hemmaway, Claire; Sutton, Dorothy; Amos, Claire; Doré, Caroline J; Kahan, Brennan; Meredith, Sarah

    2016-01-01

    Objectives Sickle With Ibuprofen and Morphine (SWIM) trial was designed to assess whether co-administration of ibuprofen (a non-steroidal anti-inflammatory drug) resulted in a reduction of opioid consumption delivered by patient-controlled analgesia (PCA) for acute pain in sickle cell disease. Design A randomised, placebo-controlled, double-blind trial. Setting UK multicentre trial in acute hospital setting. Participants Adults with sickle cell disease of any gender and phenotype aged 16 years and over. Interventions Oral ibuprofen at a dose of 800 mg three times daily or placebo in addition to opioids (morphine or diamorphine) administered via PCA pump for up to 4 days. Main outcome measures The primary outcome measure was opioid consumption over 4 days following randomisation. Results The SWIM trial closed early because it failed to randomise to its target of 316 patients within a reasonable time. Conclusions The key issues identified include the unanticipated length of time between informed consent and randomisation, difficulties in randomisation of patients in busy emergency departments, availability of trained staff at weekends and out of hours, fewer centres than expected using PCA routinely for sickle cell pain treatment, lack of research staff and support for participation, and the trial design. There are implications for future UK trials in sickle cell disease. Trial registration number ISRCTN97241637, NCT00880373; Pre-results. PMID:27288381

  11. Clinical and Radiological Evaluation after Arthroscopic Rotator Cuff Repair Using Suture Bridge Technique

    PubMed Central

    Lee, Kwang Won; Bae, Kyoung Wan; Choy, Won Sik

    2013-01-01

    Background We retrospectively assessed the clinical outcomes and investigated risk factors influencing retear after arthroscopic suture bridge repair technique for rotator cuff tear through clinical assessment and magnetic resonance arthrography (MRA). Methods Between January 2008 and April 2011, sixty-two cases of full-thickness rotator cuff tear were treated with arthroscopic suture bridge repair technique and follow-up MRA were performed. The mean age was 56.1 years, and mean follow-up period was 27.4 months. Clinical and functional outcomes were assessed using range of motion, Korean shoulder score, Constant score, and UCLA score. Radiological outcome was evaluated with preoperative and follow-up MRA. Potential predictive factors that influenced cuff retear, such as age, gender, geometric patterns of tear, size of cuff tear, acromioplasty, fatty degeneration, atrophy of cuff muscle, retraction of supraspinatus, involved muscles of cuff and osteolysis around the suture anchor were evaluated. Results Thirty cases (48.4%) revealed retear on MRA. In univariable analysis, retear was significantly more frequent in over 60 years age group (62.5%) than under 60 years age group (39.5%; p = 0.043), and also in medium to large-sized tear than small-sized tear (p = 0.003). There was significant difference in geometric pattern of tear (p = 0.015). In multivariable analysis, only age (p = 0.036) and size of tear (p = 0.030) revealed a significant difference. The mean active range of motion for forward flexion, abduction, external rotation at the side and internal rotation at the side were significantly improved at follow-up (p < 0.05). The mean Korean shoulder score, Constant score, and UCLA score increased significantly at follow-up (p < 0.01). The range of motion, Korean shoulder score, Constant score, and UCLA score did not differ significantly between the groups with retear and intact repairs (p > 0.05). The locations of retear were insertion site in 10 cases (33.3%) and

  12. Strategies to improve retention in randomised trials

    PubMed Central

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These

  13. Arthroscopic Implantation of a Bio-Inductive Collagen Scaffold for Treatment of an Articular-Sided Partial Rotator Cuff Tear

    PubMed Central

    Ryu, Richard K.N.; Ryu, Jessica H.J.; Abrams, Jeffrey S.; Savoie, Felix H.

    2015-01-01

    The treatment of articular-sided partial rotator cuff tears remains a challenge to the treating orthopaedic surgeon. Treatment algorithms have included nonoperative management, debridement alone, and debridement and subacromial decompression, as well as articular-sided rotator cuff repair and completion of the tear on the bursal side followed by a traditional arthroscopic rotator cuff repair. Implantation of a bio-inductive collagen scaffold on the bursal side of the rotator cuff to potentially heal an articular-sided tear represents a novel approach to this difficult clinical entity. PMID:26697308

  14. Do current methods for endotracheal tube cuff inflation create pressures above the recommended range? A review of the evidence.

    PubMed

    Grant, Thomas

    2013-12-01

    Inflation and measurement of endotracheal (ET) tube cuff pressure is often not seen as a critical aspect of care in surgical patients. The morbidity associated by an overinflated cuff has been regularly highlighted in literature, for example mucosal ulceration (Combes et al 2001) and vocal cord paralysis (Holley & Gildea 1971). This article will outline techniques for the methods of inflation based on the latest scientific evidence. The author will seek to examine if intraoperative cuff assessment and monitoring should become routine for the anaesthetic practitioner and if current practice for inflating cuffs creates pressures outside the safe range.

  15. Minimally Important Differences and Change Across Time in Patients Treated Surgically and Non-Surgically for Full-Thickness Rotator Cuff Tears

    PubMed Central

    Miller, Bruce S.; Robbins, Christopher; Gagnier, Joel Joseph

    2016-01-01

    in a population of patients with strictly rotator cuff disease and to explore their changes relative to MIDs across time.

  16. Clinical effects of thigh cuffs during a 7-day 6° head-down bed rest

    NASA Astrophysics Data System (ADS)

    Pavy-Le Traon, Anne; Maillet, Alain; Vasseur Clausen, Pascale; Custaud, Marc-Antoine; Alferova, Irina; Gharib, Claude; Fortrat, Jacques-Olivier

    2001-08-01

    Thigh cuffs are used by Russian cosmonauts to limit the fluid shift induced by space flight. A ground simulation using the head-down bed rest (HDBR) model was performed to assess the effects of thigh cuffs on clinical tolerance and orthostatic adaptation. 8 male healthy volunteers (32.4±1.9 years) participated twice in a 7-day HDBR — one time with thigh cuffs (worm daily from 9 am to 7 pm) (TC) and one time without (WTC). Orthostatic tolerance was assessed by a 10 minute stand test and by a LBNP test (5 min at -15, -30, -45 mmHg) before (BDC-1) and at the end of the HDBR period (R+1). Plasma volume was measured before and at the end of HDBR by the Evans blue dye dilution technique. Thigh cuffs limits headache due to fluid shift, as well as the loss in plasma volume (TC: -5.85±0.95%; WTC: -9.09±0.82%, p<0.05). The mean duration of the stand test (R+1) did not differ in the two group (TC 7.1±1.3 min; WTC 7.0±1.0 min). The increase in HR and decrease in diastolic blood pressure were slightly but significantly larger without thigh cuffs. Duration of the LBNP tests did not differ with thigh cuffs. Thigh cuffs limit the symptoms due to fluid shift and the loss in plasma volume. They partly reduced the increase in HR during orthostatic stress but had no effect on duration of orthostatic stress tests.

  17. New parachute cuff and positive end-expiratory pressure to minimize tracheal injury and prevent aspiration.

    PubMed

    Nordin, U; Lyttkens, L

    1979-01-01

    A new parachute cuff has been tested in combination with a positive end-expiratory pressure (PEEP) on mongrel dogs. During positive-pressure ventilation the intracuff and intratracheal pressures showed synchronous, identical pressure variations, and therefore theoretically with this type of cuff the pressure against the tracheal wall would be minimal. The cuff provided a seal against gas leakage from the lungs throughout the entire test period, i.e., for up to 7 h. To avoid aspiration of mouth contents during the passive exhalation phase, different amounts of PEEP were tested. A PEEP of 4.0--8.0 cm H2O always produced a seal against a column of fluid in the mouth exerting a hydrostatic pressure of 5.4--8.8 cm H2O against the cuff. This seal was maintained during the whole test period. No difference in sealing capacity was found when the cuff was used with a normal respiratory frequency (20/min) and with high-frequency positive-pressure ventilation (60/min). When the PEEP is eliminated, e.g., when the respirator is disconnected for suction of the endotracheal tube, the sealing effect will be abolished. As the cuff extends up into the larynx there will be no pooling of fluid above the cuff. The risk of aspiration can therefore be diminished by suction of oral cavity before disconnecting the respirator. With the use of the pneumatic valve principle together with high-frequency positive-pressure ventilation, an open respirator system can produce a continuous PEEP, thereby preventing aspiration even during suctioning of the tracheal tube.

  18. Incidence and characteristics of vaginal cuff dehiscence in robotic-assisted and traditional total laparoscopic hysterectomy.

    PubMed

    Dauterive, Erin; Morris, George

    2012-06-01

    This study compares the incidence of vaginal cuff dehiscence following robotic-assisted total laparoscopic hysterectomy (RALH) with total laparoscopic hysterectomy (TLH) and examines factors that may be related to risk. A retrospective chart review was performed for all patients undergoing RALH (n = 268), TLH (n = 463), and/or repair of vaginal cuff dehiscence at our clinic from July 2006 to January 2010. The cumulative incidence was calculated only for dehiscence that occurred after hysterectomies without evidence of malignancy. The incidence of cuff dehiscence in RALH (2.61%) versus TLH (1.94%) was not statistically significant (P = 0.60). However, among RALH patients, the overall incidence of cuff dehiscence after each surgeon's first 25 cases was low at 0.85%. Mean time to presentation was similar in both groups, 8.2 weeks in RALH and 8.7 weeks in TLH, with sexual intercourse the most common inciting event. Where documented, records of dehisced patients showed that all colpotomy incisions were created using monopolar cautery and closed using 0 Vicryl sutures. In TLH, 87.5% of the colpotomy incisions were closed using the Endo Stitch device in a variety of fashions. While our findings show that the overall incidence of vaginal cuff dehiscence in RALH and TLH is comparable, the data also suggest that increased experience with robotic-assisted surgery may decrease dehiscence rates over time. Randomized controlled trials comparing different methods of colpotomy creation, particularly electrocautery, and cuff closure are needed to help guide us in the best surgical practices to reduce vaginal cuff dehiscence and related complications. PMID:27628278

  19. ARTHROSCOPIC TREATMENT OF CALCIFYING TENDINITIS OF THE ROTATOR CUFF

    PubMed Central

    Neto, Arnaldo Amado Ferreira; Trevizani, Cassio Silva; Benegas, Eduardo; Malavolta, Eduardo Angeli; Gracitelli, Mauro Emílio Conforto; Bitar, Alexandre Carneiro; Neto, Francisco José dos Santos

    2015-01-01

    To evaluate the clinical and radiographic results from arthroscopic surgical treatment of the rotator cuff in patients with calcifying tendinitis. Method: A retrospective study was conducted on twenty patients who underwent arthroscopic treatment for calcifying tendinitis of the shoulder between March 1999 and November 2005. Six patients were excluded due to loss of follow-up. The average follow-up period was 41.4 months. Eight patients (57%) were female and six (43%) were male. The right side was affected in 10 cases (71%) and the left in four cases (29%). Nine cases (64%) had calcification in the supraspinatus tendon, two (14%) in the infraspinatus tendon, and three (21%) in both tendons. Results: In all cases, resection of the calcium deposits was performed by means of a needle (Jelco® No. 14) in combination with curettage (mini-curette). Two shoulders (14%) underwent subacromial decompression, and one (7%) underwent excision of the distal clavicle. A tendon-tendon suture was performed in three shoulders (21%). None of the patients underwent tendon-bone reinsertion. The mean score obtained on the UCLA scale was 33 points (26-35), thus indicating that a majority of patients had good results. In the final radiographic evaluation, none of the patients showed signs of calcification. Conclusion: Arthroscopic treatment of calcifying tendinitis of the shoulder safely allows excision of the calcification, leading to good results in relation to shoulder pain and function. PMID:27022591

  20. Cuff inflations do not affect night-time blood pressure: comparison of 24 h ambulatory blood pressure measured by a cuff and a tonometric device in type 2 diabetes.

    PubMed

    Petersen, Emilie H; Theilade, Simone; Hansen, Tine W; Lindhardt, Morten K; Rossing, Peter

    2015-12-01

    Discomfort related to cuff inflation may bias 24 h ambulatory blood pressure (BP) measurements, especially during night-time. We accessed the impact of cuff inflations by comparing 24 h BP recorded with a cuff-less tonometric wrist device and an upper-arm oscillometric cuff device. Fifty-three participants with type 2 diabetes were assigned randomly to four 24-h BP recordings with a cuff (TM2430: visit 1 or 2, and 4) and a tonometric device (BPro: visit 1 or 2, 3, and 4). The mean 24 h systolic BP was significantly higher when measured with the cuff versus the tonometric device (141.6±14.6 vs. 128.3±14.6 mmHg, P≤0.01), as was nocturnal BP (6.7±5.3 vs. 10.3±7.6%, P=0.002). In conclusion, nocturnal BP decline was higher when measured with the cuff device, suggesting that cuff inflations did not increase night-time BP. Further evaluation of the tonometric device using the updated European Society of Hypertension International Protocol revision 2010 is recommended before applying it in daily clinical practice. PMID:26154852

  1. Barbed versus conventional 2-layer continuous running sutures for laparoscopic vaginal cuff closure.

    PubMed

    Kim, Jin Hwi; Byun, Seung Won; Song, Jae Yeon; Kim, Yeon Hee; Lee, Hee Joong; Park, Tae Chul; Lee, Keun Ho; Hur, Soo Young; Park, Jong Sup; Lee, Sung Jong

    2016-09-01

    We compared results using unidirectional barbed sutures and conventional sutures for vaginal cuff closure during total laparoscopic hysterectomy (TLH).The electronic medical records and surgical videos of 170 patients who underwent TLH between January 2013 and March 2015 at Uijeong-bu St. Mary's Hospital of Catholic University of Korea were reviewed. Vaginal cuffs were closed using the 2-layer continuous running technique with unidirectional barbed sutures (V-Loc; Covidien, Mansfield, MA) in 64 patients and with polycolic acid Vicryl; Ethicon, Somerville, NJ sutures in 106 patients. Procedure time, clinical characteristics, and postoperative complications were compared between the 2 study groups. There were no differences in clinical characteristics (age, body mass index, and demographic data) between groups. The mean suturing time was significantly reduced in the barbed group (7.2 vs 12.2 minutes; P < 0.001), although the mean number of stitches was greater than in the Vicryl group (14.1 vs 12.3, P < 0.001). Perioperative complications, including episodes of vaginal bleeding, vaginal cuff cellulitis, and postoperative fever, did not differ between groups. There were no instances of vaginal cuff dehiscence in either group. Unidirectional barbed sutures can be used safely to reduce procedure time and surgical difficulty relative to conventional sutures in laparoscopic vaginal cuff closure. PMID:27684850

  2. Clinical evidence in the treatment of rotator cuff tears with hyaluronic acid

    PubMed Central

    Osti, Leonardo; Buda, Matteo; Buono, Angelo Del; Osti, Raffaella; Massari, Leo

    2015-01-01

    Summary Purpose the aim of this quantitative review is to document potential benefit and adverse effects of hyaluronic acid (HA) injection into the shoulder with rotator cuff tears. Methods a systematic literature search was performed in english PubMed, Medline, Ovid, Google Scholar and Embase databases using the combined key words “hyaluronic acid”, “rotator cuff tear”, “hyaluronate”, “shoulder”, “viscosupplementation”, with no limit regarding the year of publication. Articles were included if they reported data on clinical and functional outcomes, complications in series of patients who had undergone HA injection for management of rotator cuff tears. Two Authors screened the selected articles for title, abstract and full text in accordance with predefined inclusion and exclusion criteria. The papers were accurately analyzed focusing on objective rating scores reported. Results a total of 11 studies, prospective, 7 were randomized were included by full text. A total of 1102 patients were evaluated clinically after different HA injection compare with corticosteroid injection, physically therapies, saline solution injection and control groups. The use of HA in patients with rotator cuff tears improve VAS and functional score in all trials that we have analyzed. Conclusion intra-articular injection with HA is effective in reducing pain and improving function in shoulder with rotator cuff tears and without severe adverse reaction. Level of evidence Level I. PMID:26958534

  3. Possibilities offered by implantable miniaturized cuff-electrodes for insect neurophysiology

    PubMed Central

    Hartbauer, Manfred; Krüger, Thilo B.; Stieglitz, Thomas

    2012-01-01

    Recent advances in microsystems technology led to a miniaturization of cuff-electrodes, which suggests these electrodes not just for long-term neuronal recordings in mammalians, but also in medium-sized insects. In this study we investigated the possibilities offered by cuff-electrodes for neuroethology using insects as a model organism. The implantation in the neck of a tropical bushcricket resulted in high quality extracellular nerve recordings of different units responding to various acoustic, vibratory, optical and mechanical stimuli. In addition, multi-unit nerve activity related to leg movements was recorded in insects walking on a trackball. A drawback of bi-polar nerve recordings obtained during tethered flight was overlay of nerve activity with large amplitude muscle potentials. Interestingly, cuff-electrode recordings were robust to withstand walking and flight activity so that good quality nerve recordings were possible even three days after electrode implantation. Recording multi-unit nerve activity in intact insects required an elaborate spike sorting algorithm in order to discriminate neuronal units responding to external stimuli from background activity. In future, a combination of miniaturized cuff-electrodes and light-weight amplifiers equipped with a wireless transmitter will allow the investigation of neuronal processes underlying natural behavior in freely moving insects. By this means cuff-electrodes may contribute to the development of realistic neuronal models simulating neuronal processes underlying natural insect behavior, such like mate choice and predator avoidance. PMID:23576843

  4. Analysis of a Standardized Technique for Laparoscopic Cuff Closure following 1924 Total Laparoscopic Hysterectomies

    PubMed Central

    Peters, Alfred; Sten, Margaret S.

    2016-01-01

    Objective. To review the vaginal cuff complications from a large series of total laparoscopic hysterectomies in which the laparoscopic culdotomy closure was highly standardized. Methods. Retrospective cohort study (Canadian Task Force Classification II-3) of consecutive total and radical laparoscopic hysterectomy patients with all culdotomy closures performed laparoscopically was conducted using three guidelines: placement of all sutures 5 mm deep from the vaginal edge with a 5 mm interval, incorporation of the uterosacral ligaments with the pubocervical fascia at each angle, and, whenever possible, suturing the bladder peritoneum over the vaginal cuff edge utilizing two suture types of comparable tensile strength. Four outcomes are reviewed: dehiscence, bleeding, infection, and adhesions. Results. Of 1924 patients undergoing total laparoscopic hysterectomy, 44 patients (2.29%) experienced a vaginal cuff complication, with 19 (0.99%) requiring reoperation. Five patients (0.26%) had dehiscence after sexual penetration on days 30–83, with 3 requiring reoperation. Thirteen patients (0.68%) developed bleeding, with 9 (0.47%) requiring reoperation. Twenty-three (1.20%) patients developed infections, with 4 (0.21%) requiring reoperation. Three patients (0.16%) developed obstructive small bowel adhesions to the cuff requiring laparoscopic lysis. Conclusion. A running 5 mm deep × 5 mm apart culdotomy closure that incorporates the uterosacral ligaments with the pubocervical fascia, with reperitonealization when possible, appears to be associated with few postoperative vaginal cuff complications. PMID:27579179

  5. Possibilities offered by implantable miniaturized cuff-electrodes for insect neurophysiology.

    PubMed

    Hartbauer, Manfred; Krüger, Thilo B; Stieglitz, Thomas

    2012-05-01

    Recent advances in microsystems technology led to a miniaturization of cuff-electrodes, which suggests these electrodes not just for long-term neuronal recordings in mammalians, but also in medium-sized insects. In this study we investigated the possibilities offered by cuff-electrodes for neuroethology using insects as a model organism. The implantation in the neck of a tropical bushcricket resulted in high quality extracellular nerve recordings of different units responding to various acoustic, vibratory, optical and mechanical stimuli. In addition, multi-unit nerve activity related to leg movements was recorded in insects walking on a trackball. A drawback of bi-polar nerve recordings obtained during tethered flight was overlay of nerve activity with large amplitude muscle potentials. Interestingly, cuff-electrode recordings were robust to withstand walking and flight activity so that good quality nerve recordings were possible even three days after electrode implantation. Recording multi-unit nerve activity in intact insects required an elaborate spike sorting algorithm in order to discriminate neuronal units responding to external stimuli from background activity. In future, a combination of miniaturized cuff-electrodes and light-weight amplifiers equipped with a wireless transmitter will allow the investigation of neuronal processes underlying natural behavior in freely moving insects. By this means cuff-electrodes may contribute to the development of realistic neuronal models simulating neuronal processes underlying natural insect behavior, such like mate choice and predator avoidance.

  6. Analysis of a Standardized Technique for Laparoscopic Cuff Closure following 1924 Total Laparoscopic Hysterectomies.

    PubMed

    O'Hanlan, Katherine A; Emeney, Pamela L; Peters, Alfred; Sten, Margaret S; McCutcheon, Stacey P; Struck, Danielle M; Hoang, Joseph K

    2016-01-01

    Objective. To review the vaginal cuff complications from a large series of total laparoscopic hysterectomies in which the laparoscopic culdotomy closure was highly standardized. Methods. Retrospective cohort study (Canadian Task Force Classification II-3) of consecutive total and radical laparoscopic hysterectomy patients with all culdotomy closures performed laparoscopically was conducted using three guidelines: placement of all sutures 5 mm deep from the vaginal edge with a 5 mm interval, incorporation of the uterosacral ligaments with the pubocervical fascia at each angle, and, whenever possible, suturing the bladder peritoneum over the vaginal cuff edge utilizing two suture types of comparable tensile strength. Four outcomes are reviewed: dehiscence, bleeding, infection, and adhesions. Results. Of 1924 patients undergoing total laparoscopic hysterectomy, 44 patients (2.29%) experienced a vaginal cuff complication, with 19 (0.99%) requiring reoperation. Five patients (0.26%) had dehiscence after sexual penetration on days 30-83, with 3 requiring reoperation. Thirteen patients (0.68%) developed bleeding, with 9 (0.47%) requiring reoperation. Twenty-three (1.20%) patients developed infections, with 4 (0.21%) requiring reoperation. Three patients (0.16%) developed obstructive small bowel adhesions to the cuff requiring laparoscopic lysis. Conclusion. A running 5 mm deep × 5 mm apart culdotomy closure that incorporates the uterosacral ligaments with the pubocervical fascia, with reperitonealization when possible, appears to be associated with few postoperative vaginal cuff complications. PMID:27579179

  7. Case Report of Multiple Tracheostomy Revisions due to Persistent, Recurrent Cuff Leak

    PubMed Central

    Azimi-Bolourian, Jian P.; Hanna, Issa A.; Williams, George W.

    2015-01-01

    This case is a patient with amyotrophic lateral sclerosis who was unable to be separated from mechanical ventilator support and required a tracheostomy. The patient underwent an initial open tracheostomy utilizing flexible fiberoptic tracheoscopy (FFT) in the operating room (OR). Subsequently, he developed recurrent leaks in the tracheal tube cuff requiring multiple trips back to the operating room. The recurrent cuff leak occurred following each tube placement until the etiology of the leak was discovered during the fourth procedure. In the fourth procedure, the wound was explored more extensively, and it was found that there was a sharp, calcified, aberrant fragment of a tracheal cartilage ring protruding into the tracheal lumen, which was damaging the cuff of each tube. This fragment was not visible by multiple FFTs, nor was it visible in the wound by the surgeons until wider exploration of the wound occurred. The cartilage fragment was ultimately excised and the patient had no further cuff leaks. Aberrant tracheal cartilage should be on the differential diagnosis for cuff leaks subsequent to surgical tracheostomy (ST) or percutaneous dilatational tracheostomy (PDT). PMID:26240762

  8. Arthroscopic treatment options for irreparable rotator cuff tears of the shoulder

    PubMed Central

    Anley, Cameron M; Chan, Samuel KL; Snow, Martyn

    2014-01-01

    The management of patients with irreparable rotator cuff tears remains a challenge for orthopaedic surgeons with the final treatment option in many algorithms being either a reverse shoulder arthroplasty or a tendon transfer. The long term results of these procedures are however still widely debated, especially in younger patients. A variety of arthroscopic treatment options have been proposed for patients with an irreparable rotator cuff tear without the presence of arthritis of the glenohumeral joint. These include a simple debridement with or without a biceps tenotomy, partial rotator cuff repair with or without an interval slide, tuberplasty, graft interposition of the rotator cuff, suprascapular nerve ablation, superior capsule reconstruction and insertion of a biodegradable spacer (Inspace) to depress the humeral head. These options should be considered as part of the treatment algorithm in patients with an irreparable rotator cuff and could be used as either as an interim procedure, delaying the need for more invasive surgery in the physiologically young and active, or as potential definitive procedures in the medically unfit. The aim of this review is to highlight and summarise arthroscopic procedures and the results thereof currently utilised in the management of these challenging patients. PMID:25405083

  9. Influence of the thigh cuffs countermeasure on the cardiovascular adaptation to 0.g (14 and 21 day Mir spaceflights).

    PubMed

    Arbeille, P h; Fomina, G; Pottier, J M; Achaibou, F; Kotovskaya, A

    1995-01-01

    Assess the 0.g induced cardiac and vascular changes at rest on two cosmonauts: one using thigh cuffs from flight day 1 to 8 (Mir 14d flight) the second one not using thigh cuffs (Mir 21d flight). Both were not using intensively any other countermeasure. The ultrasound device onboard Mir with Echo, Doppler, and TM, modes was used.

  10. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial

    PubMed Central

    Komasawa, Nobuyasu; Mihara, Ryosuke; Imagawa, Kentaro; Hattori, Kazuo; Minami, Toshiaki

    2015-01-01

    The present study compared changes in cuff pressure by head and neck position between high-volume low-pressure (HVLP) and taper-shaped (taper) cuffs in a prospective randomized clinical trial. Methods. Forty patients were intubated using tracheal tubes with either HVLP (n = 20; HVLP group) or taper-shaped (n = 20; Taper group) cuffs. Initial cuff pressure was adjusted to 15, 20, or 25 cmH2O in the neutral position. Cuff pressure was evaluated after changing the head and neck positions to flexion, extension, and rotation. Results. Cuff pressure significantly increased with flexion in both HVLP and Taper groups at all initial cuff pressures. It significantly increased with extension in the HVLP group, but not in the Taper group. Cuff pressure did not significantly differ with rotation in either group and was significantly smaller in the Taper group during flexion and extension than in the HVLP group, regardless of initial cuff pressure. Conclusion. Cuff pressure changes with head and neck flexion and extension were smaller in the Taper group than in the HVLP group. Our results highlight the potential for taper cuffs to prevent excessive cuff pressure increases with positional changes in the head and neck. This trial is registered with UMIN000016119. PMID:26509152

  11. Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial.

    PubMed

    Komasawa, Nobuyasu; Mihara, Ryosuke; Imagawa, Kentaro; Hattori, Kazuo; Minami, Toshiaki

    2015-01-01

    The present study compared changes in cuff pressure by head and neck position between high-volume low-pressure (HVLP) and taper-shaped (taper) cuffs in a prospective randomized clinical trial. Methods. Forty patients were intubated using tracheal tubes with either HVLP (n = 20; HVLP group) or taper-shaped (n = 20; Taper group) cuffs. Initial cuff pressure was adjusted to 15, 20, or 25 cmH2O in the neutral position. Cuff pressure was evaluated after changing the head and neck positions to flexion, extension, and rotation. Results. Cuff pressure significantly increased with flexion in both HVLP and Taper groups at all initial cuff pressures. It significantly increased with extension in the HVLP group, but not in the Taper group. Cuff pressure did not significantly differ with rotation in either group and was significantly smaller in the Taper group during flexion and extension than in the HVLP group, regardless of initial cuff pressure. Conclusion. Cuff pressure changes with head and neck flexion and extension were smaller in the Taper group than in the HVLP group. Our results highlight the potential for taper cuffs to prevent excessive cuff pressure increases with positional changes in the head and neck. This trial is registered with UMIN000016119.

  12. Tendon transfer for irreparable rotator cuff tears: indications and surgical rationale

    PubMed Central

    Merolla, Giovanni; Chillemi, Claudio; Franceschini, Vincenzo; Cerciello, Simone; Ippolito, Giorgio; Paladini, Paolo; Porcellini, Giuseppe

    2014-01-01

    Summary Background: treatment of symptomatic irreparable rotator cuff tears is extremely challenging because, at present, there are no ideal solutions to this problem. Many patients respond favorably to nonsurgical treatment. However, when conservative measures fail to improve the patient’s pain and disability, surgery should be considered. Methods: different surgical techniques are available and the choice of the most appropriate procedure depends on the presenting symptoms, age of the patient, functional demand, medical comorbidities, joint stability and presence of arthritic changes. The transposition of the surrounding muscles to replace the rotator cuff function represents a viable option in the treatment of younger patients without glenohumeral osteoarthritis and with severe functional limitation. Purpose: aim of this study is to give an overview of the currently available evidence regarding tendon transfer procedures for irreparable rotator cuff tears. PMID:25767779

  13. Fabrication and performance analysis of a DEA cuff designed for dry-suit applications

    NASA Astrophysics Data System (ADS)

    Ahmadi, S.; Camacho Mattos, A.; Barbazza, A.; Soleimani, M.; Boscariol, P.; Menon, C.

    2013-03-01

    A method for manufacturing a cylindrical dielectric elastomer actuator (DEA) is presented. The cylindrical DEA can be used in fabricating the cuff area of dry-suits where the garment is very tight and wearing the suit is difficult. When electrically actuated, the DEA expands radially and the suit can be worn more comfortably. In order to study the performance of the DEA, a customized testing setup was designed, and silicone-made cuff samples with different material stiffnesses were tested. Analytical and FEM modeling were considered to evaluate the experimental output. The results revealed that although the stiffness of the DEA material has a direct relationship with the radial constrictive pressure caused by mechanically stretching the DEA, it has a minor effect on the actuation pressure. It was also found that stacking multiple layers of the DEA to fabricate a laminated structure enabled the attainment of a desired variation of pressure required for the implementation of an electrically tunable cuff.

  14. Rupture of endotracheal tube cuff during robot-assisted endoscopic thyroidectomy -A case report-.

    PubMed

    Lee, Hyung-Chul; Yun, Mi-Ja; Goo, Eui-Kyoung; Bahk, Jae-Hyon; Park, Hee-Pyoung; Jeon, Young-Tae; Lee, Sang Chul

    2010-12-01

    We encountered a case of a rupture of an endotracheal tube cuff during robot-assisted thyroid surgery in a 35-year-old male patient. Two hours after commencing surgery, the bellows of the ventilator were not filled and a rupture of the endotracheal tube cuff was suspected. Once the robot-manipulator is engaged, the position of the operating table cannot be altered without removing it from the patient. Reintubation with direct laryngoscopy was performed with difficulty in the narrow space between the patient's head and robot-manipulator without moving the robot away from the patient. The rupture of the endotracheal tube cuff was confirmed by observing air bubbles exiting from the balloon in water. The patient was discharged 3 days after surgery without complications. In robot-assisted thyroid surgery, a preoperative arrangement of the robot away from the patient's head to obtain easy access to the patient is essential for safe anesthetic care.

  15. Rotator cuff disorders: How to write a surgically relevant magnetic resonance imaging report?

    PubMed

    Tawfik, Ahmed M; El-Morsy, Ahmad; Badran, Mohamed Aboelnour

    2014-06-28

    Evaluation of rotator cuff is a common indication for magnetic resonance imaging (MRI) scanning of the shoulder. Conventional MRI is the most commonly used technique, while magnetic resonance (MR) arthrography is reserved for certain cases. Rotator cuff disorders are thought to be caused by a combination of internal and external mechanisms. A well-structured MRI report should comment on the relevant anatomic structures including the acromial type and orientation, the presence of os acromiale, acromio-clavicular degenerative spurs and fluid in the subacromial subdeltoid bursa. In addition, specific injuries of the rotator cuff tendons and the condition of the long head of biceps should be accurately reported. The size and extent of tendon tears, tendon retraction and fatty degeneration or atrophy of the muscles are all essential components of a surgically relevant MRI report.

  16. Rotator Cuff Tendinopathy: Navigating the Diagnosis-Management Conundrum.

    PubMed

    Lewis, Jeremy; McCreesh, Karen; Roy, Jean-Sébastien; Ginn, Karen

    2015-11-01

    Synopsis The hallmark characteristics of rotator cuff (RC) tendinopathy are pain and weakness, experienced most commonly during shoulder external rotation and elevation. Assessment is complicated by nonspecific clinical tests and the poor correlation between structural failure and symptoms. As such, diagnosis is best reached by exclusion of other potential sources of symptoms. Symptomatic incidence and prevalence data currently cannot be determined with confidence, primarily as a consequence of a lack of diagnostic accuracy, as well as the uncertainty as to the location of symptoms. People with symptoms of RC tendinopathy should derive considerable comfort from research that consistently demonstrates improvement in symptoms with a well-structured and graduated exercise program. This improvement is equivalent to outcomes reported in surgical trials, with the additional generalized benefits of exercise, less sick leave, a faster return to work, and reduced costs to the health care system. This evidence covers the spectrum of conditions that include symptomatic RC tendinopathy and atraumatic partial- and full-thickness RC tears. The principles guiding exercise treatment for RC tendinopathy include relative rest, modification of painful activities, an exercise strategy that initially does not exacerbate pain, controlled reloading, and gradual progression from simple to complex shoulder movements. Evidence also exists for a specific exercise program being beneficial for people with massive inoperable tears of the RC. Education is an essential component of rehabilitation, and attention to lifestyle factors (smoking cessation, nutrition, stress, and sleep management) may enhance outcomes. Outcomes may also be enhanced by subgrouping RC tendinopathy presentations and directing treatment strategies according to the clinical presentation and the patient's response to shoulder symptom modification procedures outlined herein. There are substantial deficits in our knowledge

  17. Effects of Rotator Cuff Pathology and Physical Therapy on In Vivo Shoulder Motion and Clinical Outcomes in Patients With a Symptomatic Full-Thickness Rotator Cuff Tear

    PubMed Central

    Baumer, Timothy G.; Chan, Derek; Mende, Veronica; Dischler, Jack; Zauel, Roger; van Holsbeeck, Marnix; Siegal, Daniel S.; Divine, George; Moutzouros, Vasilios; Bey, Michael J.

    2016-01-01

    Background: Physical therapy (PT) is often prescribed for patients with rotator cuff tears. The extent to which PT influences strength, range of motion (ROM), and patient-reported outcomes has been studied extensively, but the effect of PT on in vivo joint kinematics is not well understood. Purpose: To assess the influence of symptomatic rotator cuff pathology and the effects of PT on shoulder motion, strength, and patient-reported outcomes. Study Design: Controlled laboratory study. Methods: Twenty-five patients with a symptomatic rotator cuff tear and 25 age-matched asymptomatic control subjects were recruited. Shoulder motion was measured using a biplane radiography imaging system, strength was assessed with a Biodex dynamometer, and patient-reported outcomes were assessed using the Western Ontario Rotator Cuff Index and visual analog scale (VAS) pain scores. Data were acquired from the patients before and after 8 weeks of physical therapy. Data were acquired at 1 time point for the control subjects. Results: Compared with the control subjects, patients with a symptomatic rotator cuff tear had significantly worse pain/function scores (P < .01); less ROM (P < .01); lower abduction (ABD), external rotation (ER), and internal rotation (IR) strength (P < .01); less scapulothoracic posterior tilt (P = .05); and lower glenohumeral joint elevation (P < .01). Physical therapy resulted in improved pain/function scores (P < .01), increased ROM (P < .02), increased scapulothoracic posterior tilt (P = .05), increased glenohumeral joint elevation (P = .01), and decreased acromiohumeral distance (AHD) (P = .02). Conclusion: Compared with age-matched controls, patients had worse pain/function scores, less ROM, and lower ABD, ER, and IR strength. Patients also had less scapulothoracic anteroposterior tilt, less glenohumeral joint elevation, and an altered glenohumeral joint contact path. PT resulted in improved pain/function scores, increased ROM, greater posterior

  18. Predictors of Pain and Function in Patients With Symptomatic, Atraumatic Full-Thickness Rotator Cuff Tears

    PubMed Central

    Harris, Joshua D.; Pedroza, Angela; Jones, Grant L.

    2013-01-01

    Background Although the prevalence of full-thickness rotator cuff tears increases with age, many patients are asymptomatic and may not require surgical repair. The factors associated with pain and loss of function in patients with rotator cuff tears are not well defined. Purpose To determine which factors correlate with pain and loss of function in patients with symptomatic, atraumatic full-thickness rotator cuff tears who are enrolled in a structured physical therapy program. Study Design Cross-sectional study; Level of evidence, 3. Methods A multicenter group enrolled patients with symptomatic, atraumatic rotator cuff tears in a prospective, nonrandomized cohort study evaluating the effects of a structured physical therapy program. Time-zero patient data were reviewed to test which factors correlated with Western Ontario Rotator Cuff (WORC) index and American Shoulder and Elbow Surgeons (ASES) scores. Results A total of 389 patients were enrolled. Mean ASES score was 53.9; mean WORC score was 46.9. The following variables were associated with higher WORC and ASES scores: female sex (P = .001), education level (higher education, higher score; P <.001), active abduction (degrees; P = .021), and strength in forward elevation (P = .002) and abduction (P = .007). The following variables were associated with lower WORC and ASES scores: male sex (P = .001), atrophy of the supraspinatus (P = .04) and infraspinatus (P = .003), and presence of scapulothoracic dyskinesia (P < .001). Tear size was not a significant predictor (WORC) unless comparing isolated supraspinatus tears to supraspinatus, infraspinatus, and subscapularis tears (P = .004). Age, tear retraction, duration of symptoms, and humeral head migration were not statistically significant. Conclusion Nonsurgically modifiable factors, such as scapulothoracic dyskinesia, active abduction, and strength in forward elevation and abduction, were identified that could be addressed nonoperatively with therapy. Therefore

  19. Arterial pressure: agreement between a brachial cuff-based device and radial tonometry

    PubMed Central

    Park, Chloe M.; Korolkova, Olga; Davies, Justin E.; Parker, Kim H.; Siggers, Jennifer H.; March, Katherine; Tillin, Therese; Chaturvedi, Nish; Hughes, Alun D.

    2014-01-01

    Objectives: Aortic (central) blood pressure (BP) differs from brachial BP and may be a superior predictor of cardiovascular events. However, its measurement is currently restricted to research settings, owing to a moderate level of operator dependency. We tested a new noninvasive device in a large UK cohort. The device estimates central BP using measurements obtained with an upper arm cuff inflated to suprasystolic pressure. We compared these estimates with those obtained using radial tonometry as well as with invasively acquired measurements of aortic BP in a limited number of individuals. Methods: Consecutive cuff-based and tonometry-based estimates of the pressure waveform and the central BP were obtained from 1107 individuals (70 ± 6 years). Short-term and long-term reproducibility studies were performed on 28 individuals. Simultaneous cuff-based and invasively measured pressure traces were acquired and compared in an additional six individuals (65 ± 20 years). Results: Central systolic BP, as estimated by the cuff-based device, was found to be highly reproducible (coefficient of variation 4 and 8% for short and long-term reproducibility, respectively) and was comparable to that estimated by tonometry (average difference 3 ± 6 mmHg, intraclass correlation coefficient = 0.91). The cuff-based pressure waveforms were similar to those acquired invasively (cross-correlation coefficient 0.93), and the difference in the estimated central systolic BP was −5 ± 8 mmHg (P = 0.2). Conclusion: Cuff-based devices show promise to simplify the measurement of central BP, whilst maintaining a similar fidelity to tonometry. This could lead to improved adoption of estimates of central BP in clinical practice. PMID:24379000

  20. The influence of rotator cuff pathology on functional outcome in total shoulder replacement

    PubMed Central

    Ahearn, Nathanael; McCann, Philip A; Tasker, Andrew; Sarangi, Partha P

    2013-01-01

    Introduction: Total shoulder replacement (TSR) is a reliable treatment for glenohumeral osteoarthritis. In addition to proper component orientation, successful arthroplasty requires accurate restoration of soft tissues forces around the joint to maximize function. We hypothesized that pathological changes within the rotator cuff on preoperative magnetic resonance imaging (MRI) adversely affect the functional outcome following TSR. Materials and Methods: A retrospective analysis of case notes and MRI of patients undergoing TSR for primary glenohumeral osteoarthritis over a 4-year period was performed. Patients were divided into three groups based upon their preoperative MRI findings: (1) normal rotator cuff, (2) the presence of tendonopathy within the rotator cuff, or (3) the presence of a partial thickness rotator cuff tear. Intra-operatively tendonopathy was addressed with debridement and partial thickness tears with repair. Functional outcome was assessed with the Oxford Shoulder Score (OSS), and quick disabilities of the arm, shoulder and hand score (quick-DASH). Results: We had a full dataset of complete case-notes, PACS images, and patient reported outcome measures available for 43 patients, 15 in group 1, 14 in group 2, and 14 in group 3. Quick-DASH and OSS were calculated at a minimum of 24 months following surgery. There was no statistically significant difference between the results obtained between the three groups of either the OSS (P = 0.45), or quick-DASH (P = 0.46). Conclusions: TSR is an efficacious treatment option for patients with primary glenohumeral osteoarthritis in the medium term, even in the presence of rotator cuff tendonopathy or partial tearing. Minor changes within the cuff do not significantly affect functional outcome following TSR. PMID:24403759

  1. T lymphocytes are not required for the development of fatty degeneration after rotator cuff tear

    PubMed Central

    Gumucio, J.; Flood, M.; Harning, J.; Phan, A.; Roche, S.; Lynch, E.; Bedi, A.; Mendias, C.

    2014-01-01

    Objectives Rotator cuff tears are among the most common and debilitating upper extremity injuries. Chronic cuff tears result in atrophy and an infiltration of fat into the muscle, a condition commonly referred to as ‘fatty degeneration’. While stem cell therapies hold promise for the treatment of cuff tears, a suitable immunodeficient animal model that could be used to study human or other xenograft-based therapies for the treatment of rotator cuff injuries had not previously been identified. Methods A full-thickness, massive supraspinatus and infraspinatus tear was induced in adult T-cell deficient rats. We hypothesised that, compared with controls, 28 days after inducing a tear we would observe a decrease in muscle force production, an accumulation of type IIB fibres, and an upregulation in the expression of genes involved with muscle atrophy, fibrosis and inflammation. Results Chronic cuff tears in nude rats resulted in a 30% to 40% decrease in muscle mass, a 23% reduction in production of muscle force, and an induction of genes that regulate atrophy, fibrosis, lipid accumulation, inflammation and macrophage recruitment. Marked large lipid droplet accumulation was also present. Conclusions The extent of degenerative changes in nude rats was similar to what was observed in T-cell competent rats. T cells may not play an important role in regulating muscle degeneration following chronic muscle unloading. The general similarities between nude and T-cell competent rats suggest the nude rat is likely an appropriate preclinical model for the study of xenografts that have the potential to enhance the treatment of chronically torn rotator cuff muscles. Cite this article: Bone Joint Res 2014;3:262–72. PMID:25185444

  2. Increased Upper Trapezius Muscle Stiffness in Overhead Athletes with Rotator Cuff Tendinopathy.

    PubMed

    Leong, Hio Teng; Hug, François; Fu, Siu Ngor

    2016-01-01

    Although excessive tension of the upper trapezius (UT) is thought to contribute to rotator cuff tendinopathy, no study examined UT tension in athletes with and without rotator cuff tendinopathy. Here we used UT shear modulus measured using ultrasound shear wave elastography as an index of muscle stiffness/tension. The aims of this study were twofold: 1) to determine whether the UT muscle shear modulus is altered in athletes with rotator cuff tendinopathy compared to asymptomatic athletes, and 2) to detect optimal cut-off points of UT shear modulus in identifying athletes with rotator cuff tendinopathy. Forty-three male volleyball players (17 asymptomatic and 26 with rotator cuff tendinopathy, mean age = 22.9±3.5 years) participated in the study. UT shear modulus was quantified during active arm holding at 30° and 60° of shoulder abduction and passive arm positioning at 0°, 30° and 60° of shoulder abduction. During the active tasks, the UT shear modulus was higher in athletes with rotator cuff tendinopathy than the asymptomatic athletes (p = 0.002), regardless the arm position. During the passive tasks, athletes with rotator cuff tendinopathy exhibited a higher UT shear modulus than asymptomatic athletes only at 0° of shoulder abduction (13.0±2.5 kPa vs 10.2±1.8 kPa, p = 0.001). When considering the active task, an optimal cut-off shear modulus of 12.0 kPa at 30° of shoulder abduction (sensitivity = 0.84, specificity = 0.57, AUC = 0.757, p = 0.008) and 9.5 kPa at 60° of shoulder abduction (sensitivity = 0.88, specificity = 0.67, AUC = 0.816, p = 0.002) was detected. When considering the passive task at 0° of shoulder abduction, a cut-off of 12.2 kPa was found (sensitivity = 0.73, AUC = 0.817, p = 0.001). Findings from the present study show that monitoring passive and active UT muscle shear modulus may provide important information for the prevention/rehabilitation of rotator cuff tendinopathy. PMID:27159276

  3. Pseudomonas osteomyelitis of the proximal humerus after arthroscopic rotator cuff repair.

    PubMed

    Aydın, Nuri; Şirin, Evrim; Aydemir, Ahmet Nadir; Zengin, Gökhan

    2014-01-01

    A 59-year-old male patient was operated arthroscopically due to a rotator cuff tear. An early postoperative Pseudomonas aeruginosa infection was treated with early arthroscopic debridement and antibiotic therapy. The patient was lost to follow-up and presented to our clinic with Pseudomonas aeruginosa osteomyelitis after two years. Debridement was again performed and antibiotic-impregnated cement beads were filled into the cavity and taken out 6 weeks postoperatively. No findings of infection were observed at the patient's 2nd year follow-up. To our knowledge, this is the first case of Pseudomonas aeruginosa osteomyelitis of the shoulder after arthroscopic rotator cuff repair. PMID:25637735

  4. Arthroscopic repair of partial-thickness rotator cuff tears and SLAP lesions in professional baseball players.

    PubMed

    Conway, J E

    2001-07-01

    Internal impingement is a primary cause of shoulder pain in throwers; however, instability, internal rotation deficit, scapula muscle dysfunction, and core muscle dysfunction are also important elements of the internal impingement process. Articular surface rotator cuff tears, posterior superior labrum tears, SLAP lesions, anterior capsular ligament attenuation, and posterior capsular ligament contracture are commonly seen in throwers. Each of these conditions must be recognized and appropriately treated to ensure the best possible outcome. There is little potential for spontaneous healing of rotator cuff tears and SLAP lesions after debridement.

  5. Increased Upper Trapezius Muscle Stiffness in Overhead Athletes with Rotator Cuff Tendinopathy

    PubMed Central

    Leong, Hio Teng; Hug, François; Fu, Siu Ngor

    2016-01-01

    Although excessive tension of the upper trapezius (UT) is thought to contribute to rotator cuff tendinopathy, no study examined UT tension in athletes with and without rotator cuff tendinopathy. Here we used UT shear modulus measured using ultrasound shear wave elastography as an index of muscle stiffness/tension. The aims of this study were twofold: 1) to determine whether the UT muscle shear modulus is altered in athletes with rotator cuff tendinopathy compared to asymptomatic athletes, and 2) to detect optimal cut-off points of UT shear modulus in identifying athletes with rotator cuff tendinopathy. Forty-three male volleyball players (17 asymptomatic and 26 with rotator cuff tendinopathy, mean age = 22.9±3.5 years) participated in the study. UT shear modulus was quantified during active arm holding at 30° and 60° of shoulder abduction and passive arm positioning at 0°, 30° and 60° of shoulder abduction. During the active tasks, the UT shear modulus was higher in athletes with rotator cuff tendinopathy than the asymptomatic athletes (p = 0.002), regardless the arm position. During the passive tasks, athletes with rotator cuff tendinopathy exhibited a higher UT shear modulus than asymptomatic athletes only at 0° of shoulder abduction (13.0±2.5 kPa vs 10.2±1.8 kPa, p = 0.001). When considering the active task, an optimal cut-off shear modulus of 12.0 kPa at 30° of shoulder abduction (sensitivity = 0.84, specificity = 0.57, AUC = 0.757, p = 0.008) and 9.5 kPa at 60° of shoulder abduction (sensitivity = 0.88, specificity = 0.67, AUC = 0.816, p = 0.002) was detected. When considering the passive task at 0° of shoulder abduction, a cut-off of 12.2 kPa was found (sensitivity = 0.73, AUC = 0.817, p = 0.001). Findings from the present study show that monitoring passive and active UT muscle shear modulus may provide important information for the prevention/rehabilitation of rotator cuff tendinopathy. PMID:27159276

  6. Randomised trials for the Fitbit generation

    PubMed Central

    Dempsey, Walter; Liao, Peng; Klasnja, Pedja; Nahum-Shani, Inbal; Murphy, Susan A.

    2016-01-01

    Data from activity trackers and mobile phones can be used to craft personalised health interventions. But measuring the efficacy of these “treatments” requires a rethink of the traditional randomised trial. PMID:26807137

  7. Seven myths of randomisation in clinical trials.

    PubMed

    Senn, Stephen

    2013-04-30

    I consider seven misunderstandings that may be encountered about the nature, purpose and properties of randomisation in clinical trials. Some concern the practical realities of clinical research on patients. Others are to do with the value and purpose of balance. Still others are to do with a confusion about the role of conditioning in valid statistical inference. I consider a simple game of chance involving two dice to illustrate some points about inference and then consider the seven misunderstandings in turn. I conclude that although one should not make a fetish of randomisation, when proposing alternatives to randomisation in clinical trials, one should be very careful to be precise about the exact nature of the alternative being considered if one is to avoid the danger of underestimating the advantages that randomisation can offer. PMID:23255195

  8. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    PubMed Central

    Vas, Jorge; Perea-Milla, Emilio; Mendez, Camila; Galante, Antonia Herrera; Madrazo, Fernando; Medina, Ivan; Ortega, Caridad; Olmo, Victoria; Fernandez, Francisco Perez; Hernandez, Luz; Seminario, Jose Maria; Brioso, Mauricio; Luna, Francisco; Gordo, Isabel; Godoy, Ana Maria; Jimenez, Carmen; Ruiz, Manuel Anselmo; Montes, Joaquin; Hidalgo, Alonso; Gonzalez-Quevedo, Rosa; Bosch, Pablo; Vazquez, Antonio; Lozano, Juan Vicente

    2005-01-01

    Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis). The patients will be randomised into two groups: 1) experimental (acupuncture + physiotherapy); 2) control (TENS-placebo + physiotherapy); the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA) Scale; as secondary

  9. Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Chronic kidney disease (CKD) is common and increasing in prevalence. Cardiovascular disease (CVD) is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway. Methods The study is a prospective randomised open blinded endpoint (PROBE) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30–44 mL/min/1.73 m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25 mg once daily in addition to routine care or routine care alone and followed-up for 36 months. Discussion BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of CVD) in patients with stage 3b CKD. Trial registration EudraCT: 2012-002672-13 ISRTN: ISRCTN44522369 PMID:24886488

  10. Effects of dabigatran on the cellular and protein phase of coagulation in patients with coronary artery disease on dual antiplatelet therapy with aspirin and clopidogrel. Results from a prospective, randomised, double-blind, placebo-controlled study.

    PubMed

    Franchi, Francesco; Rollini, Fabiana; Cho, Jung Rae; King, Rhodri; Phoenix, Fladia; Bhatti, Mona; DeGroat, Christopher; Tello-Montoliu, Antonio; Zenni, Martin M; Guzman, Luis A; Bass, Theodore A; Ajjan, Ramzi A; Angiolillo, Dominick J

    2016-03-01

    There is growing interest in understanding the effects of adding an oral anticoagulant in patients on dual antiplatelet therapy (DAPT). Vitamin K antagonists (VKAs) and clopidogrel represent the most broadly utilised oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, VKAs can interfere with clopidogrel metabolism via the cytochrome P450 (CYP) system which in turn may result in an increase in platelet reactivity. Dabigatran is a direct acting (anti-II) oral anticoagulant which does not interfere with CYP and has favourable safety and efficacy profiles compared with VKAs. The pharmacodynamic (PD) effects on platelet reactivity and clot kinetic of adjunctive dabigatran therapy in patients on DAPT are poorly explored. In this prospective, randomised, double-blind, placebo-controlled PD study, patients (n=30) on maintenance DAPT with aspirin and clopidogrel were randomised to either dabigatran 150 mg bid or placebo for seven days. PD testing was performed before and after treatment using four different assays exploring multiple pathways of platelet aggregation and fibrin clot kinetics: light transmittance aggregometry (LTA), multiple electrode aggregometry (MEA), kaolin-activated thromboelastography (TEG) and turbidimetric assays. There were no differences in multiple measures of platelet reactivity investigating purinergic and non-purinergic signaling pathways assessed by LTA, MEA and TEG platelet mapping. Dabigatran significantly increased parameters related to thrombin activity and thrombus generation, and delayed fibrin clot formation, without affecting clot structure or fibrinolysis. In conclusion, in patients on DAPT with aspirin and clopidogrel, adjunctive dabigatran therapy is not associated with modulation of profiles of platelet reactivity as determined by several assays assessing multiple platelet signalling pathways. However, dabigatran significantly interferes with parameters related to thrombin activity and delays fibrin clot formation

  11. Delayed Presentation of Vaginal Cuff Dehiscence after Robotic Hysterectomy for Gynecologic Cancer: A Case Series and Review of the Literature

    PubMed Central

    Escobar, Pamela A.; Gressel, Gregory M.; Goldberg, Gary L.; Kuo, Dennis Yi-Shin

    2016-01-01

    Background. Vaginal cuff dehiscence after hysterectomy has varying incidence according to surgical approach, with highest rates associated with laparoscopic surgery. Comparative data on timing of diagnosis describe a wide range of clinical presentation from weeks to years after hysterectomy. Limited reports have focused specifically on delayed presentation of vaginal cuff dehiscence. Cases. All cases of vaginal cuff dehiscence at our institution between 2005 and 2015 were collectively reviewed and three cases were identified of women who presented with cuff dehiscence greater than 180 days from index surgery. Diagnosis occurred at 342 to 461 days after operation. One patient presented with abdominal pain, a second case presented with vaginal discharge, and the third case lacked clinical symptoms altogether. Prior to diagnosis, one case received chemotherapy and external beam radiation for Stage IB1 cervical cancer and another case received external beam radiation alone for Stage II endometrioid adenocarcinoma. All cuffs were repaired vaginally with interrupted, early absorbable suture. Conclusion. Robotic total laparoscopic hysterectomy may be associated with increased risk of vaginal cuff dehiscence. Further studies are needed to determine risk factors and patient characteristics associated with delayed presentation of vaginal cuff dehiscence in robotic total hysterectomy as well as all surgical approaches. PMID:27110413

  12. The effect of endotracheal tube cuff pressure change during gynecological laparoscopic surgery on postoperative sore throat: a control study.

    PubMed

    Geng, Guiqi; Hu, Jingyi; Huang, Shaoqiang

    2015-02-01

    Postoperative respiratory complications related to endotracheal intubation usually present as cough, sore throat, hoarseness. The aim of the study was to examine the effects of endotracheal tube cuff pressure changes during gynecological laparoscopic surgery on postoperative sore throat rates. Thirty patients who underwent gynecological laparoscopic surgery and 30 patients who underwent laparotomy under general anesthesia with endotracheal intubation were included. After induction of general anesthesia and endotracheal intubation, the cuff was inflated to 25 mmHg. At 5, 15, 30, 45 and 60 min after endotracheal intubation, cuff pressure and peak airway pressure were recorded. At 2 and 24 h after surgery, the patients were assessed for complaints of a sore throat. In patients who underwent laparotomy, cuff pressure and peak airway pressure did not change significantly at different time points after intubation. In patients who received laparoscopic surgery, cuff pressure and peak airway pressure were significantly increased compared to initial pressure at all examined time points. In both groups, the endotracheal tube cuff pressure and peak airway pressure were significantly correlated (R=0.9431, P<0.01; R=0.8468, P<0.01). Compared to patients who had undergone laparotomy, patients who had undergone laparoscopic surgery showed significantly higher sore throat scores at both 2 and 24 h after surgery (P<0.01). Pneumoperitoneum and Trendelenburg position may increase airway pressure and cuff pressure, resulting in increased incidence of postoperative sore throat.

  13. The geyser sign and torn rotator cuff: clinical significance and pathomechanics.

    PubMed

    Craig, E V

    1984-12-01

    The geyser radiographic sign on shoulder arthrogram is characterized by leakage of dye from the glenohumeral joint into the subdeltoid bursa. The dye outlines the acromioclavicular joint. It is usually an indication of a full-thickness cuff tear of long duration. The clinical occurrence and pathomechanics of this finding indicate that repair is generally difficult.

  14. The MRI geyser sign: acromioclavicular joint cysts in the setting of a chronic rotator cuff tear.

    PubMed

    Cooper, H John; Milillo, Ralph; Klein, Devon A; DiFelice, Gregory S

    2011-06-01

    We present the case of a 71-year-old man with a large acromioclavicular (AC) joint cyst successfully managed with surgical excision. AC joint cysts are soft tissue masses generally signifying underlying rotator cuff pathology. Traditionally, these cysts were identified with shoulder arthrography as a "geyser" of fluid escaping through the AC joint. Magnetic resonance imaging (MRI) is today's preferred imaging modality; we describe the MRI equivalent of the "geyser sign," signifying synovial fluid escaping through the cuff defect, across the subacromial bursa, and decompressing superiorly through a degenerated AC joint. Surgical management is preferred for symptomatic cysts. Based on a review of limited retrospective case series, recommendations for management of these lesions are as follows. Repair of the rotator cuff is preferable whenever possible. In the case of an irreparable defect, good results can be achieved through excisional AC joint arthroplasty and resection of the cyst base. Aspiration of these cysts should not be attempted, due to the high recurrence rate and potential for a draining sinus. Hemiarthroplasty also may be effective in indirectly decompressing these cysts; but given the invasive nature of this procedure, it should be reserved for patients who are also symptomatic from cuff arthropathy.

  15. Revision reverse shoulder arthroplasty in failed shoulder arthroplasties for rotator cuff deficiency

    PubMed Central

    RANDELLI, PIETRO; RANDELLI, FILIPPO; COMPAGNONI, RICCARDO; CABITZA, PAOLO; RAGONE, VINCENZA; PULICI, LUCA; BANFI, GIUSEPPE

    2015-01-01

    Purpose the aim of this systematic literature review is to report clinical outcomes of reverse shoulder arthroplasty (RSA) used as a revision surgery following failure of the primary implant due to rotator cuff insufficiency. Methods a systematic review was performed using the following key words: revision, shoulder, rotator cuff deficiency, outcome assessment, treatment outcome, complications. Studies eligible for inclusion in the review were clinical trials investigating patients in whom a primary shoulder arthroplasty implant with an incompetent rotator cuff was replaced with a reverse shoulder prosthesis. Results nine articles were identified and further reviewed. The results refer to a total of 226 shoulders that were treated with RSA as revision surgery. The patients in the studies had a mean age ranging from 64 to 72 years and the longest follow-up was 3.8 years. Improvements in function and reduction of pain were shown by many studies, but the mean Constant score ranged from 44.2 to 56. High complication rates (of up to 62%) were recorded, and a mean reoperation rate of 27.5%. Conclusions RSA as revision surgery for patients with rotator cuff deficiency is a valid option, and often the only solution available, but it should be limited to elderly patients with poor function and severe pain. Level of evidence level IV, systematic review of level I–IV studies. PMID:26151037

  16. Synthetic Patch Rotator Cuff Repair: A 10-year Follow-Up

    PubMed Central

    Shepherd, Henry M.; Lam, Patrick H.; Murrell, George A. C.

    2013-01-01

    Background The present study aimed to determine the long-term outcome as a result of the use of synthetic patches as tendon substitutes to bridge massive irreparable rotator cuff defects. Methods All patients who previously had a rotator cuff repair with a synthetic patch (2-mm Gore DUALMESH ePTFE patch; Gore, Flagstaff, AZ, USA; or a 2.87-mm Bard PTFE Felt pledgets; CR Bard, Warwick, RI, USA) were followed-up at a minimum of 8.5 years postoperatively. Assessment of shoulder pain, function, range of motion, strength and imaging was performed. Results Six patients had an interpositional repair with a synthetic patch. One patient had died. In the remaining five patients, the mean tear size at repair was 27 cm2. At 9.7 years postoperatively, all the patches remained in situ and no patient required further surgery. The repair was intact in four out of five patients. Patients had improved external rotation and abduction compared to before surgery (p < 0.02). Conclusions We describe the long-term outcomes of patients who had undergone synthetic patch rotator cuff repair for an irreparable rotator cuff tear. At 9.7 years postoperatively, patients reported less severe and more infrequent pain, as well as greater overall shoulder function, compared to before surgery. Patients also had increased passive external rotation and abduction. All the patches remain in situ and there have been no further operations on these shoulders. PMID:27582907

  17. The geyser sign and torn rotator cuff: clinical significance and pathomechanics.

    PubMed

    Craig, E V

    1984-12-01

    The geyser radiographic sign on shoulder arthrogram is characterized by leakage of dye from the glenohumeral joint into the subdeltoid bursa. The dye outlines the acromioclavicular joint. It is usually an indication of a full-thickness cuff tear of long duration. The clinical occurrence and pathomechanics of this finding indicate that repair is generally difficult. PMID:6499313

  18. The MRI geyser sign: acromioclavicular joint cysts in the setting of a chronic rotator cuff tear.

    PubMed

    Cooper, H John; Milillo, Ralph; Klein, Devon A; DiFelice, Gregory S

    2011-06-01

    We present the case of a 71-year-old man with a large acromioclavicular (AC) joint cyst successfully managed with surgical excision. AC joint cysts are soft tissue masses generally signifying underlying rotator cuff pathology. Traditionally, these cysts were identified with shoulder arthrography as a "geyser" of fluid escaping through the AC joint. Magnetic resonance imaging (MRI) is today's preferred imaging modality; we describe the MRI equivalent of the "geyser sign," signifying synovial fluid escaping through the cuff defect, across the subacromial bursa, and decompressing superiorly through a degenerated AC joint. Surgical management is preferred for symptomatic cysts. Based on a review of limited retrospective case series, recommendations for management of these lesions are as follows. Repair of the rotator cuff is preferable whenever possible. In the case of an irreparable defect, good results can be achieved through excisional AC joint arthroplasty and resection of the cyst base. Aspiration of these cysts should not be attempted, due to the high recurrence rate and potential for a draining sinus. Hemiarthroplasty also may be effective in indirectly decompressing these cysts; but given the invasive nature of this procedure, it should be reserved for patients who are also symptomatic from cuff arthropathy. PMID:21869946

  19. Microvascular anastomosis using fibrin glue and venous cuff in rat carotid artery.

    PubMed

    Sacak, Bulent; Tosun, Ugur; Egemen, Onur; Sakiz, Damlanur; Ugurlu, Kemal

    2015-04-01

    Conventional anastomosis with interrupted sutures can be time-consuming, can cause vessel narrowing, and can lead to thrombosis at the site of repair. The amount of suture material inside the lumen can impair the endothelium of the vessel, triggering thrombosis. In microsurgery, fibrin sealants have the potential beneficial effects of reducing anastomosis time and promoting accurate haemostasis at the anastomotic site. However, there has been a general reluctance to use fibrin glue for microvascular anastomoses because the fibrin polymer is highly thrombogenic and may not provide adequate strength. To overcome these problems, a novel technique was defined for microvascular anastomosis with fibrin glue and a venous cuff. Sixty-four rats in two groups are included in the study. In the experimental group (n = 32), end-to-end arterial anastomosis was performed with two stay sutures, fibrin glue, and a venous cuff. In the control group (n = 32), conventional end-to-end arterial anastomosis was performed. Fibrin glue assisted anastomosis with a venous cuff took less time, caused less bleeding at the anastomotic site, and achieved a patency rate comparable to that provided by the conventional technique. Fibrin sealant assisted microvascular anastomosis with venous cuff is a rapid, easy, and reliable technique compared to the end-to-end arterial anastomosis.

  20. Do changes in hand grip strength correlate with shoulder rotator cuff function?

    PubMed Central

    Herrington, Lee; Hoyle, Rebecca; Prescott, Evie; Bellamy, Nathan

    2016-01-01

    Background Shoulder pain as a result of rotator cuff pathology is one of the most common musculoskeletal complaints presenting within primary care. Assessment of hand grip strength has been proposed as an indicator of rotator cuff function. This experimental study assessed the relationship between grip strength and shoulder lateral rotator muscle strength in a number of different shoulder positions, aiming to investigate whether such a relationship existed and whether grip strength could be used as a functional assessment tool for the posterior cuff. Methods Twenty-seven healthy, physically active, volunteers (19 males, eight females) with no history of shoulder, upper limb or neck injury comprised the study group. The mean (SD) age was 19.8 (5.7) years (range 18 years to 23 years). Grip strength (measured with hand grip dynamometer) and lateral rotator strength (measured with a hand held dynamometer) was measured at neutral, 90° abduction, and 90° abduction with 90° external rotation. Results The correlation between grip strength and shoulder lateral rotation strength ranged between r = 0.91 (r2 = 0.84) and r = 0.72 (r2 = 0.52) across all positions. Conclusions A strong correlation between grip strength and lateral rotator strength was shown at all positions for both left and right hands, suggesting that assessment of grip strength could be used as a rotator cuff monitor of recruitment function. PMID:27583010

  1. Eccentric training as a new approach for rotator cuff tendinopathy: Review and perspectives.

    PubMed

    Camargo, Paula R; Alburquerque-Sendín, Francisco; Salvini, Tania F

    2014-11-18

    Excessive mechanical loading is considered the major cause of rotator cuff tendinopathy. Although tendon problems are very common, they are not always easy to treat. Eccentric training has been proposed as an effective conservative treatment for the Achilles and patellar tendinopathies, but less evidence exists about its effectiveness for the rotator cuff tendinopathy. The mechanotransduction process associated with an adequate dose of mechanical load might explain the beneficial results of applying the eccentric training to the tendons. An adequate load increases healing and an inadequate (over or underuse) load can deteriorate the tendon structure. Different eccentric training protocols have been used in the few studies conducted for people with rotator cuff tendinopathy. Further, the effects of the eccentric training for rotator cuff tendinopathy were only evaluated on pain, function and strength. Future studies should assess the effects of the eccentric training also on shoulder kinematics and muscle activity. Individualization of the exercise prescription, comprehension and motivation of the patients, and the establishment of specific goals, practice and efforts should all be considered when prescribing the eccentric training. In conclusion, eccentric training should be used aiming improvement of the tendon degeneration, but more evidence is necessary to establish the adequate dose-response and to determine long-term follow-up effects. PMID:25405092

  2. Preclinical Models for Translating Regenerative Medicine Therapies for Rotator Cuff Repair

    PubMed Central

    Baker, Andrew Ryan; Iannotti, Joseph P.; McCarron, Jesse A.

    2010-01-01

    Despite improvements in the understanding of rotator cuff pathology and advances in surgical treatment options, repairs of chronic rotator cuff tears often re-tear or fail to heal after surgery. Hence, there is a critical need for new regenerative repair strategies that provide effective mechanical reinforcement of rotator cuff repair as well as stimulate and enhance the patient's intrinsic healing potential. This article will discuss and identify appropriate models for translating regenerative medicine therapies for rotator cuff repair. Animal models are an essential part of the research and development pathway; however, no one animal model reproduces all of the features of the human injury condition. The rat shoulder is considered the most appropriate model to investigate the initial safety, mechanism, and efficacy of biologic treatments aimed to enhance tendon-to-bone repair. Whereas large animal models are considered more appropriate to investigate the surgical methods, safety and efficacy of the mechanical—or combination biologic/mechanical—strategies are ultimately needed for treating human patients. The human cadaver shoulder model, performed using standard-of-care repair techniques, is considered the best for establishing the surgical techniques and mechanical efficacy of various repair strategies at time zero. While preclinical models provide a critical aspect of the translational pathway for engineered tissues, controlled clinical trials and postmarketing surveillance are also needed to define the efficacy, proper indications, and the method of application for each new regenerative medicine strategy. PMID:19663651

  3. Biomechanical and functional variation in rat sciatic nerve following cuff electrode implantation

    PubMed Central

    2014-01-01

    Background Nerve cuff electrodes are commonly and successfully used for stimulating peripheral nerves. On the other hand, they occasionally induce functional and morphological changes following chronic implantation, for reasons not always clear. We hypothesize that restriction of nerve mobility due to cuff implantation may alter nerve conduction. Methods We quantified acute changes in nerve-muscle electrophysiology, using electromyography, and nerve kinematics in anesthetized Sprague Dawley rat sciatic nerves during controlled hindlimb joint movement. We compared electrophysiological and biomechanical response in uncuffed nerves and those secured within a cuff electrode using analysis of variance (ANOVA) and regression analysis. Results Tethering resulting from cuff implantation resulted in altered nerve strain and a complex biomechanical environment during joint movement. Coincident with biomechanical changes, electromyography revealed significantly increased variability in the response of conduction latency and amplitude in cuffed, but not free, nerves following joint movement. Conclusion Our findings emphasize the importance of the mechanical interface between peripheral nerves and their devices on neurophysiological performance. This work has implications for nerve device design, implantation, and prediction of long-term efficacy. PMID:24758405

  4. Inappropriate fixation of an endotracheal tube causing cuff malfunction resulting in difficult extubation.

    PubMed

    Nag, Deb Sanjay; Samaddar, Devi Prasad

    2016-01-01

    We discuss a case of difficult extubation, due to inadequate deflation of the tracheal tube cuff, despite collapse of the pilot balloon, on its aspiration. This was caused by inadvertent kinking of the pilot balloon tubing due to inappropriate tape fixation of the endotracheal tube. PMID:27591469

  5. The Single Needle Lockstitch Machine. [Making and Setting Cuffs.] Module 6.

    ERIC Educational Resources Information Center

    South Carolina State Dept. of Education, Columbia. Office of Vocational Education.

    This module on making and setting cuffs, one in a series on the single needle lockstitch sewing machine for student self-study, contains three sections. Each section includes the following parts: an introduction, directions, an objective, learning activities, student information, student self-check, check-out activities, and an instructor's final…

  6. Impact of supra-cuff suction on ventilator-associated pneumonia prevention

    PubMed Central

    de Souza, Carolina Ramos; Santana, Vivian Taciana Simioni

    2012-01-01

    Critically ill patients are intubated or tracheostomized because, in most cases, these individuals require invasive mechanical ventilation. The cannulae that are used include the cuff, which can act as a reservoir for oropharyngeal secretions, predisposing to ventilator-associated pneumonia. Studies have revealed that the suction of subglottic secretions through the dorsal suction lumen above the endotracheal tube cuff delays the onset and reduces the incidence of ventilator-associated pneumonia. The aim of this review is to assess published studies regarding the significance of using suction with a supra-cuff device for the prevention of ventilator-associated pneumonia in critically ill patients treated with orotracheal intubation or tracheostomy. Therefore, by searching national and international databases, a literature review was undertaken of studies published between the years 1986 and 2011. Few results were found relating the suction of subglottic secretions to decreased duration of mechanical ventilation and length of stay in the intensive care unit. The suction of subglottic secretions is ineffective in decreasing mortality but is effective in reducing the incidence of early-onset ventilator-associated pneumonia and hospital costs. Techniques involving continuous suction of subglottic secretions may be particularly efficient in removing secretions; however, intermittent suction appears to be the least harmful method. In conclusion, cannulae with a supra-cuff suction device enable the aspiration of subglottic secretions, providing benefits to critically ill patients by reducing the incidence of ventilator-associated pneumonia and, consequently, hospital costs - with no large-scale adverse effects. PMID:23917940

  7. Eccentric training as a new approach for rotator cuff tendinopathy: Review and perspectives

    PubMed Central

    Camargo, Paula R; Alburquerque-Sendín, Francisco; Salvini, Tania F

    2014-01-01

    Excessive mechanical loading is considered the major cause of rotator cuff tendinopathy. Although tendon problems are very common, they are not always easy to treat. Eccentric training has been proposed as an effective conservative treatment for the Achilles and patellar tendinopathies, but less evidence exists about its effectiveness for the rotator cuff tendinopathy. The mechanotransduction process associated with an adequate dose of mechanical load might explain the beneficial results of applying the eccentric training to the tendons. An adequate load increases healing and an inadequate (over or underuse) load can deteriorate the tendon structure. Different eccentric training protocols have been used in the few studies conducted for people with rotator cuff tendinopathy. Further, the effects of the eccentric training for rotator cuff tendinopathy were only evaluated on pain, function and strength. Future studies should assess the effects of the eccentric training also on shoulder kinematics and muscle activity. Individualization of the exercise prescription, comprehension and motivation of the patients, and the establishment of specific goals, practice and efforts should all be considered when prescribing the eccentric training. In conclusion, eccentric training should be used aiming improvement of the tendon degeneration, but more evidence is necessary to establish the adequate dose-response and to determine long-term follow-up effects. PMID:25405092

  8. Pulse Arrival Time Based Cuff-Less and 24-H Wearable Blood Pressure Monitoring and its Diagnostic Value in Hypertension.

    PubMed

    Zheng, Yali; Poon, Carmen C Y; Yan, Bryan P; Lau, James Y W

    2016-09-01

    Ambulatory blood pressure monitoring (ABPM) has become an essential tool in the diagnosis and management of hypertension. Current standard ABPM devices use an oscillometric cuff-based method which can cause physical discomfort to the patients with repeated inflations and deflations, especially during nighttime leading to sleep disturbance. The ability to measure ambulatory BP accurately and comfortably without a cuff would be attractive. This study validated the accuracy of a cuff-less approach for ABPM using pulse arrival time (PAT) measurements on both healthy and hypertensive subjects for potential use in hypertensive management, which is the first of its kind. The wearable cuff-less device was evaluated against a standard cuff-based device on 24 subjects of which 15 have known hypertension. BP measurements were taken from each subject over a 24-h period by the cuff-less and cuff-based devices every 15 to 30 minutes during daily activities. Mean BP of each subject during daytime, nighttime and over 24-h were calculated. Agreement between mean nighttime systolic BP (SBP) and diastolic (DBP) measured by the two devices evaluated using Bland-Altman plot were -1.4 ± 6.6 and 0.4 ± 6.7 mmHg, respectively. Receiver operator characteristics (ROC) statistics was used to assess the diagnostic accuracy of the cuff-less approach in the detection of BP above the hypertension threshold during nighttime (>120/70 mmHg). The area under ROC curves were 0.975/0.79 for nighttime. The results suggest that PAT-based approach is accurate and promising for ABPM without the issue of sleep disturbances associated with cuff-based devices. PMID:27447469

  9. Achieving a Safe Endotracheal Tube Cuff Pressure in the Prehospital Setting: Is It Time to Revise the Standard Cuff Inflation Practice?

    PubMed

    Carhart, Elliot; Stuck, Logan H; Salzman, Joshua G

    2016-01-01

    Numerous studies have reported unsafe endotracheal tube (ETT) cuff pressures (CP) in the prehospital environment. The purpose of this study was to identify an optimal cuff inflation volume (CIV) to achieve a safe CP (20-30 cmH2O). This observational study utilized 30 recently harvested ovine tracheae, which were warmed from refrigeration in a water bath at 85°F prior to testing. Each trachea was intubated with five different ETT sizes (6.0-8.0 mm), and each size tube was tested with six cuff inflation volumes (5-10 cc). The order of ETT size for each trachea and CIV for each size ETT was randomly pre-assigned. Data were descriptively summarized and categorized before mixed-effects logistic regression was used to determine optimal CIV. Only 113 CP measurements (12.6%, N = 900) were within the optimal range (M = 54.75 cmH2O, SD = 38.52), all of which resulted from a CIV 6 or 7 cc (61% and 39%, respectively). CIVs of 5 cc (n = 150) resulted in underinflation (<20 cmH2O) in all instances, while CIVs of 8, 9, or 10 cc (n = 150 each) resulted in overinflation (>30 cmH2O) in all instances, regardless of ETT size. The odds of achieving a safe CP were greater with CIV of 6 cc for tube sizes 6.0 (OR = 15.9, 95% CI = 3.85-65.58, p < 0.01) and 6.5 mm (OR = 3.16, 95% CI = 1.06-9.39, p = 0.039); however, there was no significant difference in the odds of achieving a safe CP between CIV of 6 and 7 cc for tube sizes 7.0, 7.5, or 8.0 mm. Neither trachea circumference (M = 7.11 cm, SD = 0.40), nor tissue temperature (M = 81.32°F, SD = 0.93) were found to be significant predictors of CP (p = 0.20 and 0.81, respectively). Our study showed a high frequency of CP measurements outside of the desired norms. The CIV range of 6-7 cc resulted in the highest likelihood of achieving the desired cuff pressure range, while cuffs inflated with 8-10 cc resulted in dangerously high CPs in all instances. In the absence of a more ideal solution, the results of this study suggest that narrowing the

  10. Measurement of brachial artery endothelial function using a standard blood pressure cuff.

    PubMed

    Maltz, Jonathan S; Tison, Geoffrey H; Alley, Hugh F; Budinger, Thomas F; Owens, Christopher D; Olgin, Jeffrey

    2015-11-01

    The integrity of endothelial function in major arteries (EFMA) is a powerful independent predictor of heart attack and stroke. Existing ultrasound-based non-invasive assessment methods are technically challenging and suitable only for laboratory settings. EFMA, like blood pressure (BP), is both acutely and chronically affected by factors such as lifestyle and medication. Consequently, laboratory-based measurements cannot fully gauge the effects of medical interventions on EFMA. EFMA and BP have, arguably, comparable (but complementary) value in the assessment of cardiovascular health. Widespread deployment of EFMA assessment is thus a desirable clinical goal. To this end, we propose a device based on modifying the measurement protocol of a standard electronic sphygmomanometer. The protocol involves inflating the cuff to sub-diastolic levels to enable recording of the pulse waveform before and after vasodilatory stimulus. The mechanical unloading of the arterial wall provided by the cuff amplifies the distension that occurs with each pulse, which is measured as a pressure variation in the cuff. We show that the height of the rising edge of each pulse is proportional to the change in lumen area between diastole and systole. This allows the effect of vasodilatory stimuli on the artery to be measured with high sensitivity. We compare the proposed cuff flow-mediated dilation (cFMD) method to ultrasound flow-mediated dilation (uFMD). We find significant correlation (r = 0.55, p = 0.003, N = 27) between cFMD- and uFMD-based metrics obtained when the release of a 5 min cuff occlusion is employed to induce endothelial stimulus via reactive hyperemia. cFMD is approximately proportional to the square of uFMD, representing a typical increase in sensitivity to vasodilation of 300-600%. This study illustrates the potential for an individual to conveniently measure his/her EFMA by using a low-cost reprogrammed home sphygmomanometer. PMID:26393958

  11. Clinical Outcomes of Conservative Treatment and Arthroscopic Repair of Rotator Cuff Tears: A Retrospective Observational Study

    PubMed Central

    Lee, Woo Hyung; Do, Hyun Kyung; Lee, Joong Hoon; Kim, Bo Ram; Noh, Jee Hyun; Choi, Soo Hyun; Chung, Sun Gun; Lee, Shi-Uk; Choi, Ji Eun; Kim, Seihee; Kim, Min Jee

    2016-01-01

    Objective To compare the clinical outcomes following conservative treatment and arthroscopic repair in patients with a rotator cuff tear. Methods In this retrospective study, patients aged >50 years with a symptomatic rotator cuff tear were reviewed. The rotator cuff tendons were evaluated using ultrasonography, shoulder magnetic resonance imaging or MR arthrography, and the patients with either a high-grade partial-thickness or small-to-medium-sized (≤3 cm) full-thickness tear were included in this study. The primary outcome measures were a pain assessment score and range of motion (ROM) at 1-year follow-up. The secondary outcomes were the rate of tear progression or retear along with the rate of symptom aggravation after the treatments. Results A total of 357 patients were enrolled, including 183 patients that received conservative treatment and 174 patients who received an arthroscopic repair. The pain assessment score (p<0.001) and the ROM in forward flexion (p<0.001) were significantly improved in both groups. The ROM in internal rotation did not significantly change after conservative treatment and arthroscopic repair. The pain assessment score and ROM were not significantly different between the two groups. Retear was observed in 9.6% of patients who had an arthroscopic repair and tear progression was found in 6.7% of those who underwent conservative treatment. The proportion of aggravation for pain and ROM did not significantly differ between the two groups. Conclusion The effectiveness of conservative treatment is not inferior to arthroscopic repair for patients >50 years old with a less than medium-sized rotator cuff tear in a 1-year follow-up period. Further study is warranted to find the optimal combination of conservative treatment for a symptomatic rotator cuff tear. PMID:27152275

  12. Ultrasound Dimensions of the Rotator Cuff and Other Associated Structures in Korean Healthy Adults.

    PubMed

    Kim, Kyeongwon; Kim, Hong Geum; Song, Daeheon; Yoon, Jung Yoon; Chung, Myung Eun

    2016-09-01

    In evaluating patients complaining of shoulder pain, ultrasonography is an emerging imaging tool due to convenience, low cost, high sensitivity and specificity. However, normative values of ultrasound dimensions of the shoulder to be compared with pathologic findings in Korean adults are not provided yet. We evaluated the ultrasound dimensions of the rotator cuff, long head of biceps tendon, deltoid muscle and acromioclavicular joint in Korean healthy adults. Shoulder ultrasonography was performed on 200 shoulders from 100 healthy adults. The dimensions of the thickness of rotator cuff (supraspinatus, infraspinatus, subscapularis tendon), deltoid muscle, long head of biceps tendon, subacromial subdeltoid bursa, and acromioclavicular joint interval were measured in a standardized manner. Differences in measurements among sex, age, and dominant arms were compared. The thickness of rotator cuff tendons (supraspinatus, infraspinatus, subscapularis) and deltoid muscle were significantly different between men and women. The thickness of subacromial subdeltoid bursa was significantly different between men and women for non-dominant side. In rotator cuff tendon measurements, the differences between dominant and non-dominant shoulders were not significant, which means the asymptomatic contralateral shoulder can be used to estimate the normal reference values. When stratified by age divided by 10 years, the measurements of supraspinatus, subscapularis and deltoid thickness showed tendency of increase with the age. The acromioclavicular joint interval, on the other hand, revealed decreasing tendency. This report suggests normative values of ultrasound dimensions of healthy Korean population with varying age, and can be useful as reference values in evaluating shoulder pathology, especially in rotator cuff tendon pathology. PMID:27510393

  13. Ultrasound Dimensions of the Rotator Cuff and Other Associated Structures in Korean Healthy Adults

    PubMed Central

    2016-01-01

    In evaluating patients complaining of shoulder pain, ultrasonography is an emerging imaging tool due to convenience, low cost, high sensitivity and specificity. However, normative values of ultrasound dimensions of the shoulder to be compared with pathologic findings in Korean adults are not provided yet. We evaluated the ultrasound dimensions of the rotator cuff, long head of biceps tendon, deltoid muscle and acromioclavicular joint in Korean healthy adults. Shoulder ultrasonography was performed on 200 shoulders from 100 healthy adults. The dimensions of the thickness of rotator cuff (supraspinatus, infraspinatus, subscapularis tendon), deltoid muscle, long head of biceps tendon, subacromial subdeltoid bursa, and acromioclavicular joint interval were measured in a standardized manner. Differences in measurements among sex, age, and dominant arms were compared. The thickness of rotator cuff tendons (supraspinatus, infraspinatus, subscapularis) and deltoid muscle were significantly different between men and women. The thickness of subacromial subdeltoid bursa was significantly different between men and women for non-dominant side. In rotator cuff tendon measurements, the differences between dominant and non-dominant shoulders were not significant, which means the asymptomatic contralateral shoulder can be used to estimate the normal reference values. When stratified by age divided by 10 years, the measurements of supraspinatus, subscapularis and deltoid thickness showed tendency of increase with the age. The acromioclavicular joint interval, on the other hand, revealed decreasing tendency. This report suggests normative values of ultrasound dimensions of healthy Korean population with varying age, and can be useful as reference values in evaluating shoulder pathology, especially in rotator cuff tendon pathology. PMID:27510393

  14. Measurement of brachial artery endothelial function using a standard blood pressure cuff

    PubMed Central

    Maltz, Jonathan S; Tison, Geoffrey H; Alley, Hugh F; Budinger, Thomas F; Owens, Christopher D; Olgin, Jeffrey

    2016-01-01

    The integrity of endothelial function in major arteries (EFMA) is a powerful independent predictor of heart attack and stroke. Existing ultrasound-based non-invasive assessment methods are technically challenging and suitable only for laboratory settings. EFMA, like blood pressure (BP), is both acutely and chronically affected by factors such as lifestyle and medication. Consequently, lab-based measurements cannot fully gauge the effects of medical interventions on EFMA. EFMA and BP have, arguably, comparable (but complementary) value in the assessment of cardiovascular health. Widespread deployment of EFMA assessment is thus a desirable clinical goal. To this end, we propose a device based on modifying the measurement protocol of a standard electronic sphygmomanometer. Methods The protocol involves inflating the cuff to sub-diastolic levels to enable recording of the pulse waveform before and after vasodilatory stimulus. The mechanical unloading of the arterial wall provided by the cuff amplifies the distension that occurs with each pulse, which is measured as a pressure variation in the cuff. We show that the height of the rising edge of each pulse is proportional to the change in lumen area between diastole and systole. This allows the effect of vasodilatory stimuli on the artery to be measured with high sensitivity. We compare the proposed cuff flow-mediated dilation (cFMD) method to ultrasound FMD (uFMD). Results We find significant correlation (r=0.55, p = 0.003, N=27) between cFMD- and uFMD-based metrics obtained when the release of a 5-minute cuff occlusion is employed to induce endothelial stimulus via reactive hyperemia. cFMD is approximately proportional to the square of uFMD, representing a typical increase in sensitivity to vasodilation of 300–600%. Conclusion This study illustrates the potential for an individual to conveniently measure his/her EFMA by using a low-cost reprogrammed home sphygmomanometer. PMID:26393958

  15. Partial rotator cuff injury in athletes: bursal or articular?☆

    PubMed Central

    Carvalho, Cassiano Diniz; Cohen, Carina; Belangero, Paulo Santoro; Figueiredo, Eduardo Antônio; Monteiro, Gustavo Cará; de Castro Pochini, Alberto; Andreoli, Carlos Vicente; Ejnisman, Benno

    2015-01-01

    A painful shoulder is a very common complaint among athletes, especially in the case of those in sports involving throwing. Partial lesions of the rotator cuff may be very painful and cause significant functional limitation to athletes’ sports practice. The incidence of partial lesions of the cuff is variable (13–37%). It is difficult to make the clinical and radiological diagnosis, and this condition should be borne in mind in the cases of all athletes who present symptoms of rotator cuff syndrome, including in patients who are diagnosed only with tendinopathy. Objective To evaluate the epidemiological behavior of partial lesions of the rotator cuff in both amateur and professional athletes in different types of sports. Methods We evaluated 720 medical files on athletes attended at the shoulder service of the Discipline of Sports Medicine at the Sports Traumatology Center, Federal University of São Paulo. The majority of them were men (65%). Among all the patients, 83 of them were diagnosed with partial lesions of the rotator cuff, by means of ultrasonography or magnetic resonance, or in some cases using both. We applied the binomial test to compare the proportions found. Result It was observed that intra-articular lesions predominated (67.6%) and that these occurred more frequently in athletes in sports involving throwing (66%). Bursal lesions occurred in 32.4% of the athletes, predominantly in those who did muscle building (75%). Conclusion Intra-articular lesions are more frequent than bursal lesions and they occur predominantly in athletes in sports involving throwing, while bursal lesions were more prevalent in athletes who did muscle building. PMID:26417568

  16. How do massive immobile rotator cuff tears behave after arthroscopic interval slides? Comparison with mobile tears

    PubMed Central

    FOSSATI, CHIARA; ARRIGONI, PAOLO; RAGONE, VINCENZA; SPENNACCHIO, PIETRO; BANFI, GIUSEPPE; RANDELLI, FILIPPO; RANDELLI, PIETRO

    2014-01-01

    Purpose the aim of this study was to compare clinical outcomes of contracted immobile massive rotator cuff tears mobilised through an arthroscopic interval slide technique versus massive mobile cuff tears directly repaired without any mobilisation. Methods twenty-five patients who underwent arthroscopic repair for massive rotator cuff tears with a minimum of 18 months follow-up were included. The patients were retrospectively divided into two groups. In group 1, a single or double interval slide was performed to achieve adequate tendon mobilisation. In group 2 (control group), massive rotator cuff tears were arthroscopically repaired without any additional release. Patients were evaluated with validated outcomes scores: subjective and objective Constant score, a Visual Analogue Scale (VAS) for pain, and single Assessment Numeric Evaluation (SANE). Results the two groups were comparable in terms of age, gender and involvement of the dominant arm. The mean follow-up duration was 31 months in group 1 and 28 months in group 2 (p = 0.4). The two groups showed no significant differences in SANE and VAS results (group 1: SANE 77%, VAS 1.3; group 2: SANE 88%, VAS 1.6), or in total Constant score (group 1: 66.5 ± 11; group 2: 75 ± 14; p = 0.1) and subjective Constant score (Group 1: 31 ± 5; group 2: 30.8 ± 7; p = 0.9). A significant difference was found for the objective Constant score, which was higher in the control group (group 1: 35.5 ± 7; group 2: 44 ± 8; p = 0.009). Conclusions Subjective clinical outcomes of arthroscopic repair with or without interval slides did not differ and were satisfactory. Objectively, immobile cuff tears showed inferior results. The use of interval slides might be considered a first step or an alternative to more invasive procedures for low demanding patients. Level of evidence Level III, retrospective comparative study. PMID:25606545

  17. Health-related quality of life in small-cell lung cancer: a systematic review on reporting of methods and clinical issues in randomised controlled trials.

    PubMed

    Zikos, Efstathios; Ghislain, Irina; Coens, Corneel; Ediebah, Divine E; Sloan, Elizabeth; Quinten, Chantal; Koller, Michael; van Meerbeeck, Jan P; Flechtner, Hans-Henning; Stupp, Roger; Pallis, Athanasios; Czimbalmos, Agnes; Sprangers, Mirjam A G; Bottomley, Andrew

    2014-02-01

    Small-cell lung cancer represents about 15% of all lung cancers; increasingly, randomised controlled trials of this disease measure the health-related quality of life of patients. In this Systematic Review we assess the adequacy of reporting of health-related quality-of-life methods in randomised controlled trials of small-cell lung cancer, and the potential effect of this reporting on clinical decision making. Although overall reporting of health-related quality of life was acceptable, improvements are needed to optimise the use of health-related quality of life in randomised controlled trials.

  18. The pressure exerted on the tracheal wall by two endotracheal tube cuffs: A prospective observational bench-top, clinical and radiological study

    PubMed Central

    2010-01-01

    Background The Lotrach endotracheal tube has a unique low-volume, low-pressure (LVLP) cuff, which has been designed to prevent pressure injury to the tracheal wall. We aimed to estimate the pressure exerted on the tracheal wall by the LVLP cuff and a conventional cuff in a bench-top, clinical and radiological study. Method In the bench-top study, a model trachea was intubated with the LVLP cuff and the conventional cuff. The cuff pressure was controlled using a constant pressure device. We assessed the pressure exerted on the tracheal wall by measuring the ability of the cuffs to support a column of water using a standard protocol. In the clinical study, we tested the ability of both cuffs to prevent air leak during a staged recruitment manoeuvre. In the radiological study, we recorded the degree of anatomical distortion of the trachea from both cuffs in the antero-posterior (AP) and transverse tracheal diameters. We performed statistical analysis using non-inferiority tests. Results In the bench-top study, the LVLP cuff achieved a plateau at a mean height of 25.2 cmH2O (SD 0.34). In contrast, the conventional cuff failed to maintain any water above the cuff and a plateau could not be measured. In the clinical study, the mean pressure at which air leak occurred was 30.0 +/- 0.8 cmH2O (SD 3.8) using the LVLP cuff and 32.4 +/- 0.7 cmH2O (SD 3.0) using the conventional cuff. In the radiological study, the mean degree of anatomical distortion of the trachea in AP and transverse tracheal diameter was 2.9 +/- 2.2 mm (SD 2.1) and 1.8 +/- 1.4 mm (SD 1.4) using the LVLP cuff and 4.4 +/- 1.3 mm (SD 1.4) and 2.6 +/- 1.5 mm (SD 1.6) using the conventional cuff. Conclusions The bench-top and clinical studies both demonstrated that the LVLP cuff exerted approximately 30 cmH2O of pressure on the tracheal wall. These results are supported by our radiological study. We conclude that the LVLP cuff exerts an acceptable amount of pressure on the tracheal wall when it is operated at

  19. Predictors of Outcomes after Arthroscopic Double-row Rotator Cuff Repair in 155 Cases

    PubMed Central

    Katthagen, Jan Christoph; Millett, Peter J.; Espinoza-Ervin, Christopher; Horan, Marilee P.; Ho, Charles P.; Warth, Ryan J.; Dornan, Grant

    2016-01-01

    Objectives: The purpose of this study was to analyze predictors of clinical outcomes of knotted versus knotless double-row self-reinforcing rotator cuff repairs of full-thickness rotator cuff tears with propensity score matching. Methods: Patients with arthroscopic repair of full-thickness rotator cuff tears involving the supraspinatus tendon using either a knotted or knotless linked, self-reinforcing double-row technique were included in the study. Preoperative subjective evaluation was performed using the ASES and SF-12 PCS scores. After a minimum two-year follow-up period, ASES and SF-12 PCS scores were collected again along with the SANE score, the QuickDASH score, and patient satisfaction. All data were collected prospectively and retrospectively reviewed. Postoperative ASES and SF-12 PCS scores were then modeled using inverse propensity score weighting in a multiple linear regression model (MLR) with multiple imputations. Age, sex, baseline ASES score, length of follow-up, number of anchors, worker’s compensation, previous cuff repair, and double-row repair technique (knotted or knotless) were the covariates used in this model. Results: 155 shoulders in 151 patients (109 men, 42 women; mean age at time of surgery 59±10 years) were eligible for inclusion. Outcomes data were available for 130 of 148 shoulders (87.8%) after exclusion of seven shoulders (4.5%) that underwent revision rotator cuff repair before final follow up (n=33/39 in the knotted group [84.6%]; n=97/109 [88.9%] in the knotless group).The mean follow-up was 2.9 years (range, 2.0-5.4 years). Overall, postoperative outcomes scores were significantly improved when compared to preoperative baselines (p<0.05), with a median postoperative ASES score of 97 for the entire cohort. Our model showed that previous rotator cuff repair had a significant negative effect on postoperative ASES (β = -12.7, p<0.001) and SF-12 PCS scores (β = -5.0, p = 0.036). A workers’ compensation claim (β = -10.6, p

  20. Infraspinatus/Teres Minor Transfer Biceps In Situ Tenodesis Procedure: Initial Results of a Technique for Massive Cuff Tears

    PubMed Central

    Fletcher, Matt D. A.

    2013-01-01

    Massive rotator cuff tears may not be primarily repairable with salvage options not necessarily providing acceptable results. Extrinsic tendon transfer is a significant undertaking with prolonged rehabilitation and variable outcome. A novel technique for the reconstruction of massive tears, not amenable to primary repair, by performing a transfer of the intrinsic posterior rotator cuff onto an intact, tenodesed long head of biceps tendon acting as a scaffold for the intrinsic transfer is described. The clinical results at short to medium term in 17 initial patients are presented. Encouraging results from this study suggest that this is a viable option for the management of massive rotator cuff tears with an intact posterior cuff with results equal or superior to other reconstructive techniques. PMID:24967113

  1. A stimulating nerve cuff for chronic in vivo measurements of torque produced about the ankle in the mouse.

    PubMed

    Warren, G L; Ingalls, C P; Armstrong, R B

    1998-06-01

    Specific muscle training and chronic contractile measurements are difficult in rodents, especially in the mouse. The primary reason for this is the lack of a means for stimulating the motor nerve that does not damage the nerve and that permits reproducible measurements of contractility. In this paper, we describe procedures for the construction and implantation of a stimulating nerve cuff for use on the mouse common peroneal nerve. We demonstrate that nerve cuff implantation success rates can be high (i.e., 75-93%), as determined from measurements of maximal isometric torque produced by the anterior crural muscles. Isometric torque production is not adversely affected by the nerve cuff because the torque produced matches that observed in our established percutaneous stimulation model. We also demonstrate that use of the nerve cuff for stimulation is compatible with electromyographic measurements made on the tibialis anterior muscle, with no sign of stimulation artifact in the electromyographic signal. PMID:9609814

  2. Changes in endotracheal tube cuff pressure during laparoscopic surgery in head-up or head-down position

    PubMed Central

    2014-01-01

    Background The abdominal insufflation and surgical positioning in the laparoscopic surgery have been reported to result in an increase of airway pressure. However, associated effects on changes of endotracheal tube cuff pressure are not well established. Methods 70 patients undergoing elective laparoscopic colorectal tumor resection (head-down position, n = 38) and laparoscopic cholecystecomy (head-up position, n = 32) were enrolled and were compared to 15 patients undergoing elective open abdominal surgery. Changes of cuff and airway pressures before and after abdominal insufflation in supine position and after head-down or head-up positioning were analysed and compared. Results There was no significant cuff and airway pressure changes during the first fifteen minutes in open abdominal surgery. After insufflation, the cuff pressure increased from 26 ± 3 to 32 ± 6 and 27 ± 3 to 33 ± 5 cmH2O in patients receiving laparoscopic cholecystecomy and laparoscopic colorectal tumor resection respectively (both p < 0.001). The head-down tilt further increased cuff pressure from 33 ± 5 to 35 ± 5 cmH2O (p < 0.001). There six patients undergoing colorectal tumor resection (18.8%) and eight patients undergoing cholecystecomy (21.1%) had a total increase of cuff pressure more than 10 cm H2O (18.8%). There was no significant correlation between increase of cuff pressure and either the patient's body mass index or the common range of intra-abdominal pressure (10-15 mmHg) used in laparoscopic surgery. Conclusions An increase of endotracheal tube cuff pressure may occur during laparoscopic surgery especially in the head-down position. PMID:25210501

  3. EXERCISE REHABILITATION IN THE NON-OPERATIVE MANAGEMENT OF ROTATOR CUFF TEARS: A REVIEW OF THE LITERATURE

    PubMed Central

    Edwards, Peter; Ebert, Jay; Joss, Brendan; Bhabra, Gev; Ackland, Tim; Wang, Allan

    2016-01-01

    The incidence of rotator cuff tears increases with age, with full-thickness rotator cuff tears present in approximately 25% of individuals in their sixties, and more than 50% of those in their eighties. While surgery is considered an effective treatment, recurrent tears at the insertion site are common, especially with degenerative tears, which are frequent in the older population. More recently, there has been increasing interest in exercise rehabilitation and physical therapy as a means to manage partial and full thickness tears of the rotator cuff by addressing weakness and functional deficits. Recent studies have suggested that patients opting for physical therapy have demonstrated high satisfaction, an improvement in function, and success in avoiding surgery. When considering the increasing rate of shoulder surgery and the associated economic and social burden rotator cuff surgery places on both the patient and the health care system, non-surgical management such as physical therapy and exercise may, in selected cases, be a treatment alternative to surgical repair. The purpose of this clinical commentary is to provide an overview of rotator cuff pathology and pathogenesis, and to present an evidence-based case for the role of conservative rehabilitation in the management of rotator cuff injuries. Level of Evidence Level 5 PMID:27104061

  4. Greater tuberosity notch: an important indicator of articular-side partial rotator cuff tears in the shoulders of throwing athletes.

    PubMed

    Nakagawa, S; Yoneda, M; Hayashida, K; Wakitani, S; Okamura, K

    2001-01-01

    We examined the location of rotator cuff tears, associated labral injuries, and notches on the greater tuberosity of the humeral head in shoulders of throwing athletes. Arthroscopic findings (rotator cuff tear, labral condition, and greater tuberosity notch) as well as other factors (duration of playing baseball, range of motion, and joint laxity) of 61 baseball players were retrospectively studied. The presence of a greater tuberosity notch was also evaluated for by plain radiographs. Forty patients had articular-side partial rotator cuff tears, most of which occurred in the interval between the supraspinatus and infraspinatus tendons. The existence of a rotator cuff tear was not related to the range of motion, joint laxity, the detachment of the superior glenoid labrum, or posterosuperior labral injury. Greater tuberosity notches were recognized in 38 shoulders by arthroscopy and most were detected on plain radiographs. The presence of a notch was significantly related to the existence of a rotator cuff tear, while the size of the notch was significantly related to the depth and width of the tear. The greater tuberosity notch seems to be one of the most important diagnostic indicators for a rotator cuff tear in throwing athletes.

  5. Alcohol intake and cardiovascular risk factors: A Mendelian randomisation study

    PubMed Central

    Cho, Yoonsu; Shin, So-Youn; Won, Sungho; Relton, Caroline L; Davey Smith, George; Shin, Min-Jeong

    2015-01-01

    Mendelian randomisation studies from Asia suggest detrimental influences of alcohol on cardiovascular risk factors, but such associations are observed mainly in men. The absence of associations of genetic variants (e.g. rs671 in ALDH2) with such risk factors in women – who drank little in these populations – provides evidence that the observations are not due to genetic pleiotropy. Here, we present a Mendelian randomisation study in a South Korean population (3,365 men and 3,787 women) that 1) provides robust evidence that alcohol consumption adversely affects several cardiovascular disease risk factors, including blood pressure, waist to hip ratio, fasting blood glucose and triglyceride levels. Alcohol also increases HDL cholesterol and lowers LDL cholesterol. Our study also 2) replicates sex differences in associations which suggests pleiotropy does not underlie the associations, 3) provides further evidence that association is not due to pleiotropy by showing null effects in male non-drinkers, and 4) illustrates a way to measure population-level association where alcohol intake is stratified by sex. In conclusion, population-level instrumental variable estimation (utilizing interaction of rs671 in ALDH2 and sex as an instrument) strengthens causal inference regarding the largely adverse influence of alcohol intake on cardiovascular health in an Asian population. PMID:26687910

  6. A randomised controlled trial of treatment for idiopathic intracranial hypertension.

    PubMed

    Ball, Alexandra K; Howman, Andrew; Wheatley, Keith; Burdon, Michael A; Matthews, Timothy; Jacks, Andrew S; Lawden, Mark; Sivaguru, Arul; Furmston, Alexandra; Howell, Steven; Sharrack, Basil; Davies, M Brendan; Sinclair, Alexandra J; Clarke, Carl E

    2011-05-01

    The cause of idiopathic intracranial hypertension (IIH) remains unknown, and no consensus exists on how patients should be monitored and treated. Acetazolamide is a common treatment but has never been examined in a randomised controlled trial. The objectives of this pilot trial are to prospectively evaluate the use of acetazolamide, to explore various outcome measures and to inform the design of a definitive trial in IIH. Fifty patients were recruited from six centres over 23 months and randomised to receive acetazolamide (n = 25) or no acetazolamide (n = 25). Symptoms, body weight, visual function and health-related quality-of-life measures were recorded over a 12-month period. Recruited patients had typical features of mild IIH and most showed improvement, with 44% judged to have IIH in remission at the end of the trial. Difficulties with recruitment were highlighted as well as poor compliance with acetazolamide therapy (12 patients). A composite measure of IIH status was tested, and the strongest concordance with final disease status was seen with perimetry (Somers' D = 0.66) and optic disc appearance (D = 0.59). Based on the study data, a sample size of 320 would be required to demonstrate a 20% treatment effect in a substantive trial. Clinical trials in IIH require pragmatic design to involve sufficiently large numbers of patients. Future studies should incorporate weighted composite scores to reflect the relative importance of common outcome measures in IIH.

  7. A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study

    PubMed Central

    2012-01-01

    Background Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff) are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability. Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise) in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance. Methods/Design A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist’s. An economic analysis will be conducted from an NHS and Personal Social

  8. Interposition Porcine Acellular Dermal Matrix Xenograft Successful Alternative in Treatment for Massive Rotator Cuff

    PubMed Central

    Neumann, Julie; Zgonis, Miltiadis H.; Reay, Kathleen Dolores; Mayer, Stephanie W.; Boggess, Blake; Toth, Alison P.

    2016-01-01

    Objectives: Despite advances in the surgical techniques of rotator cuff repair (RCR), the management of massive rotator cuff tears in shoulders without glenohumeral arthritis poses a difficult problem for surgeons. Failure of massive rotator cuff repairs range from 20-90% at one to two years postoperatively using arthrography, ultrasound, or magnetic resonance imaging. Additionally, there are inconsistent outcomes reported with debridement alone of massive rotator cuff tears as well as limitations seen with other current methods of operative intervention including arthroplasty and tendon transfers. The purpose of this prospective, comparative study was to determine if the repair of massive rotator cuff tears using an interposition porcine acellular dermal matrix xenograft improves subjective function, pain, range of motion, and strength at greater than two years follow-up. To our knowledge, this is the largest prospective series reporting outcomes of using porcine acellular dermal matrix xenograft as an interposition graft. Methods: Thirty-seven patients (37 shoulders) with an average age of 66 years (range 51-80 years) were prospectively followed for 33 months (range 23-48) following massive RCR using porcine acellular dermal matrix interposition xenograft. Subjective outcomes were measured using the Visual Analog Scale (VAS) pain score (0-10, 0 = no pain), Modified American Shoulder and Elbow Score (M-ASES), and Short-Form12 (SF-12) scores. Preoperative and postoperative objective outcome measures included active range of motion and supraspinatus and infraspinatus manual muscle strength. Postoperative outcome measures included quantitative muscle strength using a dynamometer and static and dynamic ultrasonography to assess the integrity of the repair. Results: Average VAS pain score decreased from 4.5 to 1.1 (P<0.001). Average postoperative M-ASES was 89.23. Average postoperative SF-12 was 52.6. Mean forward flexion, external and internal rotation significantly

  9. Arthroscopic Superior Capsular Reconstruction for Treatment of Massive Irreparable Rotator Cuff Tears

    PubMed Central

    Hirahara, Alan M.; Adams, Christopher R.

    2015-01-01

    Massive irreparable rotator cuff tears have been troublesome entities to treat, especially in younger patients. Few good options exist, leaving most patients in recent years receiving a reverse total shoulder arthroplasty. Reverse shoulder arthroplasty carries serious risks, a limited lifespan, and no other viable options should it fail. Recent biomechanical studies have shown that the superior capsule is critical to containing the glenohumeral joint reduced, allowing the larger muscles like the deltoid and pectoralis major to function properly. The superior capsular reconstruction is an anatomic reconstruction of the superior capsule to restore the normal restraint to superior translation that occurs with a deficient rotator cuff. The technique described in this article is an arthroscopic reconstruction of the superior capsule with dermal allograft. PMID:26870638

  10. Isokinetic torque imbalances in the rotator cuff of the elite water polo player.

    PubMed

    McMaster, W C; Long, S C; Caiozzo, V J

    1991-01-01

    The specific repetitive activity of water polo, like baseball pitching, emphasizes adduction and internal rotation. This study used the Cybex II to evaluate the isokinetic strength of the rotator cuff in elite water polo players and in a group of control subjects. The water polo players were significantly stronger than the controls. Of greater importance was the confirmation of imbalances in the rotator cuff force couples of adduction/abduction and external/internal rotation. These changes are similar to those reported for pitchers. The adductors in the water polo group had gained in relative strength resulting in an increase in the adduction/abduction ratio to about 2:1. The internal rotators had gained in relative strength resulting in a decrease in the external/internal ratio to about 0.6:1. For both force couples the differences are more apparent at a slow speed. Side-to-side differences were not significant.

  11. Ultrasound vs. MRI in the assessment of rotator cuff structure prior to shoulder arthroplasty

    PubMed Central

    Fischer, Christian Alexander; Weber, Marc-André; Neubecker, Clément; Bruckner, Thomas; Tanner, Michael; Zeifang, Felix

    2015-01-01

    Background/Aims We compared the accuracy of US to 3 T Tesla MRI for the detection of rotator cuff and long biceps tendon pathologies before joint replacement. Methods 45 patients were prospectively included. Results For the supraspinatus tendon, the accuracy of US when using MRI as reference was 91.1%. For the infraspinatus tendon, the accuracy with MRI as reference was 84.4%. The subscapularis tendon was consistently assessed by US and MRI in 35/45 patients (accuracy 77.8%). For the long biceps tendon the accuracy was 86.7%. Conclusion US detection of rotator cuff and biceps tendon integrity is comparable to MRI and should be preferred in revision cases. PMID:25829757

  12. A self-management programme for COPD: a randomised controlled trial.

    PubMed

    Mitchell, Katy E; Johnson-Warrington, Vicki; Apps, Lindsay D; Bankart, John; Sewell, Louise; Williams, Johanna E; Rees, Karen; Jolly, Kate; Steiner, Michael; Morgan, Mike; Singh, Sally J

    2014-12-01

    Studies of programmes of self-management support for chronic obstructive pulmonary disease (COPD) have been inconclusive. The Self-Management Programme of Activity, Coping and Education (SPACE) FOR COPD is a 6-week self-management intervention for COPD, and this study aimed to evaluate the effectiveness of this intervention in primary care. A single-blind randomised controlled trial recruited people with COPD from primary care and randomised participants to receive usual care or SPACE FOR COPD. Outcome measures were performed at baseline, 6 weeks and 6 months. The primary outcome was symptom burden, measured by the self-reported Chronic Respiratory Questionnaire (CRQ-SR) dyspnoea domain. Secondary outcomes included other domains of the CRQ-SR, shuttle walking tests, disease knowledge, anxiety, depression, self-efficacy, smoking status and healthcare utilisation. 184 people with COPD were recruited and randomised. At 6 weeks, there were significant differences between groups in CRQ-SR dyspnoea, fatigue and emotion scores, exercise performance, anxiety, and disease knowledge. At 6 months, there was no between-group difference in change in CRQ-SR dyspnoea. Exercise performance, anxiety and smoking status were significantly different between groups at 6 months, in favour of the intervention. This brief self-management intervention did not improve dyspnoea over and above usual care at 6 months; however, there were gains in anxiety, exercise performance, and disease knowledge. PMID:25186259

  13. Quantitative assessment of rotator cuff muscle elasticity: Reliability and feasibility of shear wave elastography.

    PubMed

    Hatta, Taku; Giambini, Hugo; Uehara, Kosuke; Okamoto, Seiji; Chen, Shigao; Sperling, John W; Itoi, Eiji; An, Kai-Nan

    2015-11-01

    Ultrasound imaging has been used to evaluate various shoulder pathologies, whereas, quantification of the rotator cuff muscle stiffness using shear wave elastography (SWE) has not been verified. The purpose of this study was to investigate the reliability and feasibility of SWE measurements for the quantification of supraspinatus (SSP) muscle elasticity. Thirty cadaveric shoulders (18 intact and 12 with torn rotator cuff) were used. Intra- and inter-observer reliability was evaluated on an established SWE technique for measuring the SSP muscle elasticity. To assess the effect of overlying soft tissues above the SSP muscle, SWE values were measured with the transducer placed on the skin, on the subcutaneous fat after removing the skin, on the trapezius muscle after removing the subcutaneous fat, and directly on the SSP muscle. In addition, SWE measurements on 4 shoulder positions (0°, 30°, 60°, and 90° abduction) were compared in those with/without rotator cuff tears. Intra- and inter-observer reliability of SWE measurements were excellent for all regions in SSP muscle. Also, removing the overlying soft tissue showed no significant difference on SWE values measured in the SSP muscle. The SSP muscle with 0° abduction showed large SWE values, whereas, shoulders with large-massive tear showed smaller variation throughout the adduction-abduction positions. SWE is a reliable and feasible tool for quantitatively assessing the SSP muscle elasticity. This study also presented SWE measurements on the SSP muscle under various shoulder abduction positions which might help characterize patterns in accordance to the size of rotator cuff tears. PMID:26472309

  14. Arthroscopic Knotless, Double-Row, Extended Linked Repair for Massive Rotator Cuff Tears.

    PubMed

    Greenspoon, Joshua A; Petri, Maximilian; Millett, Peter J

    2016-02-01

    The management of massive rotator cuff tears remains a challenge for physicians, with failure rates being higher when compared with smaller tears. Many surgical treatment options exist including debridement with biceps tenodesis, complete repair, partial repair, repair with augmentation devices, superior capsule reconstruction, tendon transfer, and reverse total shoulder arthroplasty. The purpose of this article is to describe our preferred surgical technique for a complete arthroscopic repair using an extended linked, knotless, double-row construct. PMID:27330944

  15. Estimation of central aortic pressure waveform features derived from the brachial cuff volume displacement waveform.

    PubMed

    Butlin, Mark; Qasem, Ahmad; Avolio, Alberto P

    2012-01-01

    There is increasing interest in non-invasive estimation of central aortic waveform parameters in the clinical setting. However, controversy has arisen around radial tonometric based systems due to the requirement of a trained operator or lack of ease of use, especially in the clinical environment. A recently developed device utilizes a novel algorithm for brachial cuff based assessment of aortic pressure values and waveform (SphygmoCor XCEL, AtCor Medical). The cuff was inflated to 10 mmHg below an individual's diastolic blood pressure and the brachial volume displacement waveform recorded. The aortic waveform was derived using proprietary digital signal processing and transfer function applied to the recorded waveform. The aortic waveform was also estimated using a validated technique (radial tonometry based assessment, SphygmoCor, AtCor Medical). Measurements were taken in triplicate with each device in 30 people (17 female) aged 22 to 79 years of age. An average for each device for each individual was calculated, and the results from the two devices were compared using regression and Bland-Altman analysis. A high correlation was found between the devices for measures of aortic systolic (R(2)=0.99) and diastolic (R(2)=0.98) pressure. Augmentation index and subendocardial viability ratio both had a between device R(2) value of 0.82. The difference between devices for measured aortic systolic pressure was 0.5±1.8 mmHg, and for augmentation index, 1.8±7.0%. The brachial cuff based approach, with an individualized sub-diastolic cuff pressure, provides an operator independent method of assessing not only systolic pressure, but also aortic waveform features, comparable to existing validated tonometric-based methods.

  16. Massive rotator cuff tears in patients younger than 65 years. What treatment options are available?

    PubMed

    Favard, L; Berhouet, J; Colmar, M; Boukobza, E; Richou, J; Sonnard, A; Huguet, D; Courage, O

    2009-06-01

    Management of massive rotator cuff tears is a therapeutic challenge in patients younger than 65 years, particularly if still working. According to our hypothesis, choice of the most appropriate treatment option mainly depends on the patient's functional status and on two predictive factors: height of the subacromial space and fatty muscle infiltration. This is a retrospective, multicenter study of a series of 296 patients younger than 65 years, including 176 males and 120 females with extensive or massive cuff tear. Patients had loss of elevation or external rotation or both in 162 cases. Four types of management of massive rotator cuff tear were performed in this study: anatomical watertight repairs, palliative treatments and partial repairs, watertight repairs using flaps or cuff prostheses and reverse shoulder prostheses. At follow-up, the Constant score (65.6+/-3.4) and active elevation (147.7 degrees +/-32 degrees) had significantly improved. Active external rotation with elbow at the side, and acromiohumeral interval (AHI) were unchanged. Work-related injuries, previous surgeries and complications were correlated with a poorer Constant score. At follow-up, the anatomical repair sub-group had a significantly better Constant score than the three other treatment groups but involved patients with unchanged AHI and a low degree of fatty infiltration of the infraspinatus muscle. The reverse shoulder prostheses sub-group showed better outcomes in terms of function benefits. The presence of a long biceps was correlated with the use of a palliative treatment. In the light of the results and literature, an approach to treatment is suggested related to the functional capacity of patients, the AHI and the degree of fatty infiltration of the infraspinatus and subscapularis muscles. PMID:19427282

  17. Comparing normal and torn rotator cuff tendons using dynamic shear analysis.

    PubMed

    Chaudhury, S; Holland, C; Vollrath, F; Carr, A J

    2011-07-01

    This study reports the application of a novel method for quantitatively determining differences in the mechanical properties of healthy and torn rotator cuff tissues. In order to overcome problems of stress risers at the grip-tendon interface that can obscure mechanical measurements of small tendons, we conducted our investigation using dynamic shear analysis. Rotator cuff tendon specimens were obtained from 100 patients during shoulder surgery. They included 82 differently sized tears and 18 matched controls. We subjected biopsy samples of 3 mm in diameter to oscillatory deformation under compression using dynamic shear analysis. The storage modulus (G') was calculated as an indicator of mechanical integrity. Normal tendons had a significantly higher storage modulus than torn tendons, indicating that torn tendons are mechanically weaker than normal tendons (p = 0.003). Normal tendons had a significantly higher mean shear modulus than tendons with massive tears (p < 0.01). Dynamic shear analysis allows the determination of shear mechanical properties of small tissue specimens obtained intra-operatively that could not be studied by conventional methods of tensile testing. These methods could be employed to investigate other musculoskeletal tissues. This pilot study provides some insight into mechanisms that might contribute to the failure of repair surgery, and with future application could help direct the most appropriate treatment for specific rotator cuff tears.

  18. Reverse Shoulder Arthroplasty for Management of Postinfectious Arthropathy With Rotator Cuff Deficiency.

    PubMed

    Morris, Brent J; Waggenspack, Wame N; Laughlin, Mitzi S; Elkousy, Hussein A; Gartsman, Gary M; Edwards, T Bradley

    2015-08-01

    Treatment of patients with rotator cuff deficiency and arthritis in the setting of a prior glenohumeral infection (postinfectious arthropathy) is complex, with little evidence to guide treatment. The current authors present their approach to management of these patients and clinical outcomes after reverse shoulder arthroplasty (RSA). All primary RSAs performed for postinfectious arthropathy and rotator cuff deficiency with native glenohumeral joints were identified in a prospective shoulder arthroplasty registry. Eight patients with a minimum of 2-year follow-up were included in the analysis. Clinical outcomes, including the Constant score, the American Shoulder and Elbow Surgeons (ASES) score, the Western Ontario Osteoarthritis Shoulder (WOOS) index, the Single Assessment Numeric Evaluation (SANE) score, and range of motion measurements, were assessed preoperatively and at final follow-up. At an average follow-up of 4.4 years, no patient had a clinically detectable recurrence of infection. Significant improvements were noted in all outcome scores from preoperative evaluation to final follow-up after RSA, including Constant score (P=.003), ASES score (P<.001), WOOS index (P=.002), SANE score (P=.025), forward flexion (P<.001), abduction (P<.001), and external rotation (P=.020). Seven of 8 patients reported they were satisfied or very satisfied at final follow-up. Reverse shoulder arthroplasty can be performed in patients without significant medical comorbidities in the setting of postinfectious arthropathy and rotator cuff deficiency with a low risk of recurrence of infection. Significant clinical improvements were noted at short-term follow-up. PMID:26270757

  19. Platelets and plasma stimulate sheep rotator cuff tendon tenocytes when cultured in an extracellular matrix scaffold.

    PubMed

    Kelly, Brian A; Proffen, Benedikt L; Haslauer, Carla M; Murray, Martha M

    2016-04-01

    The addition of platelet-rich plasma (PRP) to rotator cuff repair has not translated into improved outcomes after surgery. However, recent work stimulating ligament healing has demonstrated improved outcomes when PRP or whole blood is combined with an extracellular matrix carrier. The objective of this study was to evaluate the effect of three components of blood (plasma, platelets, and macrophages) on the in vitro activity of ovine rotator cuff cells cultured in an extracellular matrix environment. Tenocytes were obtained from six ovine infraspinatus tendons and cultured over 14 days in an extracellular matrix scaffold with the following additives: (1) plasma (PPP), (2) plasma and platelets (PAP), (3) plasma and macrophages (PPPM), (4) plasma, platelets and macrophages (PAPM), (5) phosphate buffered saline (PBS), and (6) PBS with macrophages (PBSM). Assays measuring cellular metabolism (AlamarBlue), proliferation (Quantitative DNA assay), synthesis of collagen and cytokines (SIRCOL, TNF-α and IL-10 ELISA, and MMP assay), and collagen gene expression (qPCR) were performed over the duration of the experiment, as well as histology at the conclusion. Plasma was found to stimulate cell attachment and spreading on the scaffold, as well as cellular proliferation. Platelets also stimulated cell proliferation, cellular metabolism, transition of cells to a myofibroblast phenotype, and contraction of the scaffolds. The addition of macrophages did not have any significant effect on the sheep rotator cuff cells in vitro. In vivo studies are needed to determine whether these changes in cellular function will translate into improved tendon healing.

  20. RESULTS OF SURGICAL TREATMENT OF DENERATIVE ARTHROPATHY OF THE ROTATOR CUFF USING HEMIARTHROPLASTY- CTA®

    PubMed Central

    Filho, Rômulo Brasil; Ribeiro, Fabiano Rebouças; Tenor, Antonio Carlos; Filho, Cantidio Salvador Filardi; da Costa, Guilherme Barbieri Leme; Storti, Thiago Medeiros; da Costa Garcia, André; Lutfi, Hilton Vargas

    2015-01-01

    Objective: To assess results of CTA® partial shoulder arthroplasty for treatment of degenerative arthropathy of the rotator cuff. Methods: Between December 2006 and June 2009, 23 shoulders of 23 patients were submitted to CTA® type partial shoulder arthroplasty for treatment of arthropathy secondary to rotator cuff injury. Post-operative follow up time ranged from 6 to 35 months. Mean age was 74.1 years. Patients were predominantly female, representing 78.3% of cases. The right limb was affected in 18 patients. All patients had undergone at least 6 months of physiotherapy without improvement of the algetic picture, and being submitted to surgery by the same surgical team. None of the patients had history of surgery on the affected shoulder. The method elected for assessing patients during post-operative follow up was based on UCLA scoring criteria. Results: Improvement in pain was observed in all patients after arthroplasty. Mean UCLA pain score was 9.22 (ranging from 10 to 8). Mean function was 6 (10 to 2). Active frontal flexion was 2.39 (highest score 4 and lowest 0). Mean frontal flexion force was 4.09, maximum was 5 and minimum 3. Mean score on the UCLA was 26.52. 95% were satisfied with the surgery. Conclusion: CTA® type partial shoulder arthroplasty produced satisfactory results in the treatment of degenerative arthropathy of the rotator cuff and had a low rate of complications. PMID:27028431

  1. In Vivo Measurement of Rotator Cuff Tear Tension: Medial Versus Lateral Footprint Position.

    PubMed

    Dierckman, Brian D; Wang, David W; Bahk, Michael S; Burns, Joseph P; Getelman, Mark H

    2016-01-01

    We conducted a study to evaluate in vivo tension applied to the rotator cuff tendon positioned at the medial versus lateral footprint during arthroscopic rotator cuff repair. We evaluated 20 consecutive patients who underwent arthroscopic rotator cuff repair. During repair, a grasper was inserted through a lateral portal, and a digital weigh scale was attached. The tendon was grasped and translated to the medial footprint, and tension recorded. After a relaxation period, the tendon edge was translated to the lateral footprint, and tension recorded. Mean (SD) tension was 0.41 (0.33) pound when tendons were positioned at the medial footprint and 2.21 (1.20) pounds when they were positioned at the lateral footprint, representing a 5.4-fold difference (P < .0001). For smaller tears (≤ 20 mm anterior-posterior), 7.6 times less tension was applied to the tendons when pulled to the medial versus lateral footprint. For larger tears, 4.1 times less tension was applied to the tendons when pulled to the medial versus lateral footprint. This study demonstrated a significant, 5.4-fold increase in tension when the tendon edge was reduced to the lateral as opposed to the medial footprint in vivo. PMID:26991588

  2. In Vivo Measurement of Rotator Cuff Tear Tension: Medial Versus Lateral Footprint Position.

    PubMed

    Dierckman, Brian D; Wang, David W; Bahk, Michael S; Burns, Joseph P; Getelman, Mark H

    2016-01-01

    We conducted a study to evaluate in vivo tension applied to the rotator cuff tendon positioned at the medial versus lateral footprint during arthroscopic rotator cuff repair. We evaluated 20 consecutive patients who underwent arthroscopic rotator cuff repair. During repair, a grasper was inserted through a lateral portal, and a digital weigh scale was attached. The tendon was grasped and translated to the medial footprint, and tension recorded. After a relaxation period, the tendon edge was translated to the lateral footprint, and tension recorded. Mean (SD) tension was 0.41 (0.33) pound when tendons were positioned at the medial footprint and 2.21 (1.20) pounds when they were positioned at the lateral footprint, representing a 5.4-fold difference (P < .0001). For smaller tears (≤ 20 mm anterior-posterior), 7.6 times less tension was applied to the tendons when pulled to the medial versus lateral footprint. For larger tears, 4.1 times less tension was applied to the tendons when pulled to the medial versus lateral footprint. This study demonstrated a significant, 5.4-fold increase in tension when the tendon edge was reduced to the lateral as opposed to the medial footprint in vivo.

  3. Association of Oversized Tracheal Tubes and Cuff Overinsufflation With Postintubation Tracheal Ruptures

    PubMed Central

    Sudhoff, Tobias H.; Seidl, Rainer O.; Estel, Barbara

    2015-01-01

    Objectives Postintubation tracheal ruptures (PTR) are rare but cause severe complications. Our objective was to investigate the tracheal pattern of injury resulting from cuff inflation of the tracheal tube, to study the two main factors responsible for PTR (cuff overinsufflation and inapplicable tube sizes), and to explain the context, why small women are particularly susceptible to PTR. Methods Experimental study performed on 28 fresh human laryngotracheal specimens (16 males, 12 females) within 24 hours post autopsy. Artificial ventilation was simulated by using an underwater construction and a standard tracheal tube. Tube sizes were selected according to our previously published nomogram. Tracheal lesions were detected visually and tracheal diameters measured. The influence of body size, sex difference and appropriate tube size were investigated according to patient height. Results In all 28 cases, the typical tracheal lesion pattern was a longitudinal median rupture of the posterior trachea. Appropriate tube sizes according to body size caused PTR with significantly higher cuff pressure when compared with oversized tubes. An increased risk of PTR was found in shorter patients, when oversized tubes were used. Sex difference did not have any significant influence. Conclusion This experimental model provides information about tracheal patterns in PTR for the first time. The model confirms by experiment the observations of case series in PTR patients, and therefore emphasizes the importance of correct tube size selection according to patient height. This minimizes the risk of PTR, especially in shorter patients, who have an increased risk of PTR when oversized tubes are used. PMID:26622963

  4. Effect of rotator cuff exercise on humeral rotation torque in healthy individuals.

    PubMed

    Moncrief, Scott A; Lau, Jeffery D; Gale, Judith R; Scott, Samuel A

    2002-05-01

    Conservative management of rotator cuff pathology often involves certain therapeutic exercises. Although a major goal of these exercises is to increase strength of the rotator cuff, little empirical evidence supports this assertion. In this study, 34 nonpathologic young adults were pretested using a LIDO Multijoint II isokinetic device for average and peak torque generated during internal and external rotation. Subjects were arbitrarily assigned to a right-arm- or left-arm-trained group, exercised for 4 weeks, and then posttested for changes in humeral rotation torque. Moderate but significant increases in torque (8-10%) as well as in total work done were observed in both groups, only in the trained arm. Subjects who trained the nondominant (left) arm experienced gains similar to those who trained the right arm. Gains were significant in the case of both internal and external rotation (also average as well as peak torque), with men and women experiencing the same relative increases. These data, in addition to supporting the use of selected exercises to increase humeral rotation torque in a healthy population, offer a potential model for the rehabilitation of patients with rotator cuff injury. PMID:11991780

  5. COMPARISON OF COMPLEMENTARY EXAMS IN THE DIAGNOSIS OF ROTATOR CUFF INJURIES

    PubMed Central

    El-Kouba, Gabriel; Andreas Huber, Thomas; Freitas, José Renato Wilke; Steglich, Valdir; Ayzemberg, Henrique; Santos, Adriano M.

    2015-01-01

    The aim of this study was to evaluate the accuracy of simple radiography, ultrasound and magnetic resonance imaging (MRI) in diagnosing rotator cuff injuries, comparing their findings with open or arthroscopic surgery findings. Methods: Protocols of the Shoulder and Elbow Surgery Service for patients undergoing surgical treatment for rotator cuff injuries diagnosed by means of radiography, ultrasound and/or MRI between 2002 and 2007 were evaluated. Based on the data gathered, we analyzed the sensitivity, specificity, positive predictive value, negative predictive value and accuracy of these complementary examinations, compared with the findings during the surgical procedures. Results: This study included 147 patients with a mean age of 46.09 years. All the patients had undergone a radiography examination, 101 had undergone ultrasound examination and 72 had undergone MRI. We found sensitivity of 13.8%, specificity of 2.6% and accuracy of 30% with radiography; sensitivity of 57.6%, specificity of 29.6% and accuracy of 51.4% with ultrasound; and sensitivity of 86.6%, specificity of 22.2% and accuracy of 63.3% with MRI. Conclusion: Radiography was found to be a specific examination when the mirror sign was present. MRI and ultrasound were shown to be reliable methods with high accuracy for diagnosing rotator cuff injuries. PMID:27022589

  6. EVALUATION OF THE RESULTS FROM REOPERATIONS ON PATIENTS WITH ROTATOR CUFF LESIONS

    PubMed Central

    Miyazaki, Alberto Naoki; Fregoneze, Marcelo; Santos, Pedro Doneux; da Silva, Luciana Andrade; do Val Sella, Guilherme; Santos, Ruy Mesquita Maranhão; de Souza, Adriano; Estelles, José Renato Depari; Checchia, Sérgio Luiz

    2015-01-01

    Objectives: To assess the results from open or arthroscopic surgical treatment on patients with symptomatic recurrence of rotator cuff injuries. Methods: Between December 1990 and July 2007, 30 patients were assessed and underwent reoperation performed by the Shoulder and Elbow Surgery Group of the Department of Orthopedics and Traumatology, Fernandinho Simonsen Wing, Santa Casa de São Paulo, because of dehiscence of the rotator cuff suture. The study included patients with symptomatic recurrence of the injury and with at least 24 months of postoperative follow-up. Results: According to the UCLA evaluation criteria, 21 patients (70%) showed excellent or good outcomes; and nine patients (30%) showed fair or poor outcomes. Conclusion: Open or arthroscopic surgical treatment of recurrent rotator cuff injuries tended to present worse results than from the primary repair. In this study, we found that 70% of the results were excellent and good. The presence of extensive injuries in the reoperation tended to evolve with larger numbers of unsatisfactory results. In our study, we obtained better results from arthroscopic surgery than from open surgery. PMID:27026985

  7. Reverse Shoulder Arthroplasty for Management of Postinfectious Arthropathy With Rotator Cuff Deficiency.

    PubMed

    Morris, Brent J; Waggenspack, Wame N; Laughlin, Mitzi S; Elkousy, Hussein A; Gartsman, Gary M; Edwards, T Bradley

    2015-08-01

    Treatment of patients with rotator cuff deficiency and arthritis in the setting of a prior glenohumeral infection (postinfectious arthropathy) is complex, with little evidence to guide treatment. The current authors present their approach to management of these patients and clinical outcomes after reverse shoulder arthroplasty (RSA). All primary RSAs performed for postinfectious arthropathy and rotator cuff deficiency with native glenohumeral joints were identified in a prospective shoulder arthroplasty registry. Eight patients with a minimum of 2-year follow-up were included in the analysis. Clinical outcomes, including the Constant score, the American Shoulder and Elbow Surgeons (ASES) score, the Western Ontario Osteoarthritis Shoulder (WOOS) index, the Single Assessment Numeric Evaluation (SANE) score, and range of motion measurements, were assessed preoperatively and at final follow-up. At an average follow-up of 4.4 years, no patient had a clinically detectable recurrence of infection. Significant improvements were noted in all outcome scores from preoperative evaluation to final follow-up after RSA, including Constant score (P=.003), ASES score (P<.001), WOOS index (P=.002), SANE score (P=.025), forward flexion (P<.001), abduction (P<.001), and external rotation (P=.020). Seven of 8 patients reported they were satisfied or very satisfied at final follow-up. Reverse shoulder arthroplasty can be performed in patients without significant medical comorbidities in the setting of postinfectious arthropathy and rotator cuff deficiency with a low risk of recurrence of infection. Significant clinical improvements were noted at short-term follow-up.

  8. A Canine Non-Weight-Bearing Model with Radial Neurectomy for Rotator Cuff Repair

    PubMed Central

    Ji, Xiaoxi; Bao, Nirong; An, Kai-Nan; Amadio, Peter C.; Steinmann, Scott P.; Zhao, Chunfeng

    2015-01-01

    Background The major concern of using a large animal model to study rotator cuff repair is the high rate of repair retears. The purpose of this study was to test a non-weight-bearing (NWB) canine model for rotator cuff repair research. Methods First, in the in vitro study, 18 shoulders were randomized to 3 groups. 1) Full-width transections repaired with modified Mason-Allen sutures using 3-0 polyglactin suture, 2) Group 1 repaired using number 2 (#2) polyester braid and long-chain polyethylene suture, and 3) Partial-width transections leaving the superior 2 mm infraspinatus tendon intact without repair. In the in vivo study of 6 dogs, the infraspinatus tendon was partially transected as the same as the in vitro group 3. A radial neurectomy was performed to prevent weight bearing. The operated limb was slung in a custom-made jacket for 6 weeks. Results In the in vitro study, mean ultimate tensile load and stiffness in Group 2 were significantly higher than Group 1 and 3 (p<0.05). In the in vivo study, gross inspection and histology showed that the preserved superior 2-mm portion of the infraspinatus tendon remained intact with normal structure. Conclusions Based on the biomechanical and histological findings, this canine NWB model may be an appropriate and useful model for studies of rotator cuff repair. PMID:26107616

  9. FATTY MUSCLE INFILTRATION IN CUFF TEAR: PRE AND POST OPERATIVE EVALUATION BY MRI

    PubMed Central

    Miyazaki, Alberto Naoki; Santos, Pedro Doneux; da Silva, Luciana Andrade; Sella, Guilherme do Val; Miranda, Eduardo Régis de Alencar Bona; Zampieri, Rodrigo

    2015-01-01

    ABSTRACT Objective: To evaluate the fatty infiltration and atrophy of the supraespinatus in the pre- and postoperative of a rotator cuff lesion (RCL), by MRI. Methods: Ten patients with full-thickness rotator cuff tears who had undergone surgical arthroscopic rotator cuff repair between September and December 2011 were included. This is a prospective study, with analysis and comparison of fatty infiltration and atrophy of the supraespinatus. The occupation ratio was measured using the magic selection tool in Adobe Photoshop CS3(r) on T1 oblique sagittal Y-view MRI. Through Photoshop, the proportion occupied by the muscle belly regarding its fossae was calculated. Results: There was a statistically significant increase in the muscle ratio (p=0.013) comparing images pre and postoperative, analyzed by the Wilcoxon T test. Conclusion: The proportion of the supraspinal muscle above the pit increases in the immediate postoperative period, probably due to the traction exerted on the tendon at the time of repair. Level of Evidence II, Cohort Study. PMID:26981032

  10. COMPREHENSIVE STRENGTH TRAINING PROGRAM FOR A RECREATIONAL SENIOR GOLFER 11-MONTHS AFTER A ROTATOR CUFF REPAIR

    PubMed Central

    Meira, Erik P.; En Gilpin, Hui; Brunette, Meredith

    2011-01-01

    Background and Purpose: Golf is a popular sport played by hundreds of thousands of individuals of all ages and of varying skill levels. An orthopedic or sports-related injury and/or surgery may limit an individual's sport participation, require him/her to complete a course of rehabilitation, and initiate (or resume) a sport-specific training program. Unlike the availability of evidence to guide postsurgical rehabilitation and sport-specific training of athletes from sports other than golf, there have only been two reports describing outcomes after surgery and for golfers. The purpose of this case report is to present a post-rehabilitation return to sport-training program for a recreational golfer 11-months after a rotator cuff repair. Case Description: The subject, a 67-year old female, injured her right shoulder requiring a rotator cuff repair 11-months prior to her participation in a golf fitness training program. The subject participated in six training sessions over seven week period consisting of general strengthening exercises (including exercises for the rotator cuff), exercises for the core, plyometrics, and power exercises. Outcomes: The subject made improvements in power and muscular endurance of the core. She was able to resume golf at the completion of the training program. Discussion: The subject was able to make functional improvements and return to golf after participation in a comprehensive strength program. Additional studies are necessary to improve program design for golfers who wish to return to sport after shoulder surgery. PMID:22163096

  11. Treatment of massive rotator-cuff tears with a polyester ligament (LARS) patch.

    PubMed

    Petrie, Michael J; Ismaiel, A Hany

    2013-12-01

    We describe and analyse the results of our technique for repairing chronic massive tears (Goutallier grade 3 or 4) of the rotator cuff using a ligament augmentation and reconstruction system. This prospective, single surgeon series included 29 symptomatic patients (21 male, 8 female) with a mean age of 67.1 years who underwent 31 ligament augmentation and reconstruction system procedures (two bilateral procedures) with a mean follow-up period of 3 years. All patients had clinical, radiographic, magnetic resonance imaging and arthroscopic evidence of a chronic massive rotator cuff tear. The primary outcome measure was assessed using the Oxford Shoulder Score and visual analogue score pre-operatively and at follow-up. Postoperative overall Oxford shoulder score and visual analogue score results demonstrated a statistically significant improvement at follow-up, compared with pre-operative values (p < 0.0001). Post-operative acromio-humeral interval showed a statistically significant increase when compared to pre-operative radiographs (p = 0.0004). Two patients required revision with good postoperative results. We believe that, in the appropriate age group, the ligament augmentation and reconstruction system repair offers a good option for chronic, primary, non-closable rotator cuff defects in terms of pain relief and function. PMID:24563965

  12. The development and validation of a questionnaire for rotator cuff disorders: The Functional Shoulder Score

    PubMed Central

    Ibrahim, Edward F; Petrou, Charalambos; Galanos, Antonis

    2015-01-01

    Background The purpose of the present study was to validate the Functional Shoulder Score (FSS), a new patient-reported outcome score specifically designed to evaluate patients with rotator cuff disorders. Methods One hundred and nineteen patients were assessed using two shoulder scoring systems [the FSS and the Constant–Murley Score (CMS)] at 3 weeks pre- and 6 months post-arthroscopic rotator cuff surgery. The reliability, validity, responsiveness and interpretability of the FSS were evaluated. Results Reliability analysis (test–retest) showed an intraclass correlation coefficient value of 0.96 [95% confidence interval (CI) = 0.92 to 0.98]. Internal consistency analysis revealed a Cronbach's alpha coefficient of 0.93. The Pearson correlation coefficient FSS-CMS was 0.782 pre-operatively and 0.737 postoperatively (p < 0.0005). There was a statistically significant increase in FSS scores postoperatively, an effect size of 3.06 and standardized response mean of 2.80. The value for minimal detectable change was ±8.38 scale points (based on a 90% CI) and the minimal clinically important difference for improvement was 24.7 ± 5.4 points. Conclusions The FSS is a patient-reported outcome measure that can easily be incorporated into clinical practice, providing a quick, reliable, valid and practical measure for rotator cuff problems. The questionnaire is highly sensitive to clinical change. PMID:27582986

  13. Difference in isokinetic torque acceleration energy of the rotator cuff: competitive male pitchers versus male nonathletes.

    PubMed

    Manske, Robert C; Tajchman, Casey S; Stranghoner, Todd A; Ellenbecker, Todd S

    2004-08-01

    Rotator cuff function is critical to the overhead athlete. Rotator cuff power is felt to be important in the overhead athlete during the throwing motion. Little research exists regarding torque acceleration energy (TAE) in overhead athletes. Twenty-five males were divided into 2 groups consisting of overhead athletes (pitchers) (n = 12) and nonoverhead athletes (controls) (n = 13). All participants were given a concentric velocity spectrum isokinetic test at speeds of 60 degrees (1.05 r), 180 degrees (3.16 r), and 300 degrees.s(-1) (5.26 r) to both the dominant and nondominant shoulder internal and external rotators. Significant differences were found for all internal rotator TAE scores (p = 0.000-0.016), at each of the 3 velocities, when comparing dominant to nondominant arms of both overhead athletes and nonoverhead athletes. Only 60 degrees.s(-1) (1.05 r) was found to be different during external rotation TAE testing of the overhead athletes (p = 0.027) but was not found in the control subjects. Post hoc analysis revealed no differences between dominant or nondominant TAE scores when comparisons were made between overhead athletes and controls. Results may reveal that power of the rotator cuff muscles may not be a critical component of the overhead throwing motion.

  14. Transverse versus longitudinal tripolar configuration for selective stimulation with multipolar cuff electrodes.

    PubMed

    Nielsen, Thomas N; Kurstjens, G A Mathijs; Struijk, Johannes J

    2011-04-01

    The ability to stimulate subareas of a nerve selectively is highly desirable, since it has the potential of simplifying surgery to implanting one cuff on a large nerve instead of many cuffs on smaller nerves or muscles, or alternatively can improve function where surgical access to the smaller nerves is limited. In this paper, stimulation was performed with a four-channel multipolar cuff electrode implanted on the sciatic nerve of nine rabbits to compare the extensively researched longitudinal tripolar configuration with the transverse tripolar configuration, which has received less interest. The performance of these configurations was evaluated in terms of selectivity in recruitment of the three branches of the sciatic nerve. The results showed that the transverse configuration was able to selectively activate the sciatic nerve branches to a functionally relevant level in more cases than the longitudinal configuration (20/27 versus 11/27 branches) and overall achieved a higher mean selectivity [0.79 ± 0.13 versus 0.61 ± 0.09 (mean ± standard deviation)]. The transverse configuration was most successful at recruiting the small cutaneous and medium-sized peroneal branches, and less successful at recruiting the large tibial nerve. PMID:21421427

  15. [Extracorporeal shockwave therapy (ESWT) in tendinosis calcarea of the rotator cuff. Long-term results and efficacy].

    PubMed

    Daecke, W; Kusnierczak, D; Loew, M

    2002-07-01

    Calcifying tendinitis (TC) of the rotator cuff is a transient shoulder disease with a high rate of spontaneous resorption of the deposit. Therefore, primary treatment should be conservative. In cases of persistent pain despite conservative treatment, extracorporeal shock wave therapy (ESWT) can be performed as an alternative minimally invasive method. Various short-term studies have demonstrated the efficiency of ESWT for TC. To evaluate the short- and long-term results, complications, and the number of operations avoided by ESWT, a prospective study with 115 patients was performed over a period of 4 years. The patients had received high-energy ESWT once (group A: n = 56) or twice (group B: n = 59). Six months after therapy, 47% in group A and 77% in group B showed evidence of disappearance or disintegration of the calcium deposits. Pain relief was achieved in 45% of group A and 53% of group B. Four years after treatment, 20% of the patients had undergone surgery on the involved shoulder. Of the remaining patients, 59% (68 patients) were seen for follow-up. Subjectively, 78% of group A and 87% of group B judged the treatment to be successful. X-ray examination revealed complete or partial resorption of the calcium deposit in 93% in both groups. The Constant score increased from 45 before treatment to 88 in group A and 85 in group B after treatment. ESWT was successful for about 70% of the treated patients with no long-term complications seen.

  16. Evaluation of functional results from shoulders after arthroscopic repair of complete rotator cuff tears associated with traumatic anterior dislocation

    PubMed Central

    Godinho, Glaydson Gomes; Freitas, José Márcio Alves; de Oliveira França, Flávio; Santos, Flávio Márcio Lago; de Simoni, Leandro Furtado; Godinho, Pedro Couto

    2016-01-01

    Objective To evaluate the clinical outcome of arthroscopic rotator cuff fixation and, when present, simultaneous repair of the Bankart lesion caused by traumatic dislocation; and to assess whether the size of the rotator cuff injury caused by traumatic dislocation has any influence on the postoperative clinical outcomes. Methods Thirty-three patients with traumatic shoulder dislocation and complete rotator cuff injury, with at least two years of follow up, were retrospectively evaluated. For analysis purposes, the patients were divided into groups: presence of fixed Bankart lesion or absence of this lesion, and rotator cuff lesions smaller than 3.0 cm (group A) or greater than or equal to 3.0 cm (group B). All the patients underwent arthroscopic repair of the lesions and were evaluated postoperatively by means of the UCLA (University of California at Los Angeles) score and strength measurements. Results The group with Bankart lesion repair had a postoperative UCLA score of 33.96, while the score of the group without Bankart lesion was 33.7, without statistical significance (p = 0.743). Group A had a postoperative UCLA score of 34.35 and group B, 33.15, without statistical significance (p = 0.416). Conclusion The functional outcomes of the patients who only presented complete rotator cuff tearing after traumatic shoulder dislocation, which underwent arthroscopic repair, were similar to the outcomes of those who presented an associated with a Bankart lesion that was corrected simultaneously with the rotator cuff injury. The extent of the original rotator cuff injury did not alter the functional results in the postoperative evaluation. PMID:27069884

  17. Diagnostic Performance and Reliability of Ultrasonography for Fatty Degeneration of the Rotator Cuff Muscles

    PubMed Central

    Wall, Lindley B.; Teefey, Sharlene A.; Middleton, William D.; Dahiya, Nirvikar; Steger-May, Karen; Kim, H. Mike; Wessell, Daniel; Yamaguchi, Ken

    2012-01-01

    Background: Diagnostic evaluation of rotator cuff muscle quality is important to determine indications for potential operative repair. Ultrasonography has developed into an accepted and useful tool for evaluating rotator cuff tendon tears; however, its use for evaluating rotator muscle quality has not been well established. The purpose of this study was to investigate the diagnostic performance and observer reliability of ultrasonography in grading fatty degeneration of the posterior and superior rotator cuff muscles. Methods: The supraspinatus, infraspinatus, and teres minor muscles were prospectively evaluated with magnetic resonance imaging (MRI) and ultrasonography in eighty patients with shoulder pain. The degree of fatty degeneration on MRI was graded by four independent raters on the basis of the modified Goutallier grading system. Ultrasonographic evaluation of fatty degeneration was performed by one of three radiologists with use of a three-point scale. The two scoring systems were compared to determine the diagnostic performance of ultrasonography. The interobserver and intraobserver reliability of MRI grading by the four raters were determined. The interobserver reliability of ultrasonography among the three radiologists was determined in a separate group of thirty study subjects. The weighted Cohen kappa, percentage agreement, sensitivity, and specificity were calculated. Results: The accuracy of ultrasonography for the detection of fatty degeneration, as assessed on the basis of the percentage agreement with MRI, was 92.5% for the supraspinatus and infraspinatus muscles and 87.5% for the teres minor. The sensitivity was 84.6% for the supraspinatus, 95.6% for the infraspinatus, and 87.5% for the teres minor. The specificity was 96.3% for the supraspinatus, 91.2% for the infraspinatus, and 87.5% for the teres minor. The agreement between MRI and ultrasonography was substantial for the supraspinatus and infraspinatus (kappa = 0.78 and 0.71, respectively

  18. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial.

    PubMed Central

    Wang, E E; Milner, R; Allen, U; Maj, H

    1992-01-01

    A randomised double blind trial was conducted to determine the efficacy of inhaled bronchodilators, salbutamol and ipratropium bromide, compared with placebo in the treatment of bronchiolitis. Patients, who were 2 months to 2 years of age and without underlying cardiac or pulmonary disease, received drug 1 (salbutamol or saline placebo) followed one hour later by drug 2 (ipratropium bromide or placebo). Both agents were administered every four hours. The patients were allocated to one of four groups according to a factorial design. The four groups were similar in demographic characteristics, initial oxygenation, and clinical score. The change in oxygen saturation of recipients of both agents was significantly better than that of recipients of salbutamol alone or ipratropium bromide alone. This change, however, was not statistically different from that of the control group. No difference was observed in the clinical score or hospital duration. Inhaled bronchodilators did not improve the condition of hospitalised mild bronchiolitis. PMID:1533504

  19. Interobserver Agreement in the Classification of Partial-Thickness Rotator Cuff Tears Using the Snyder Classification System

    PubMed Central

    Lee, Christopher S.; Davis, Shane M.; Doremus, Brittany; Kouk, Shalen; Stetson, William B.

    2016-01-01

    Background: At present, there is no widely accepted classification system for partial-thickness rotator cuff tears, and as a result, optimal treatment remains controversial. Purpose: To examine the interobserver reliability and accuracy of classifying partial rotator cuff tears using the Snyder classification system. We hypothesized that the Snyder classification would be reproducible with high reliability and accuracy. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Twenty-seven orthopaedic surgeons reviewed 10 video-recorded shoulder arthroscopies. Each surgeon was provided with a description of the Snyder classification system for partial-thickness rotator cuff tears and was then instructed to use this system to describe each tear. Interrater kappa statistics and percentage agreement between observers were calculated to measure the level of agreement. Surgeon experience as well as fellowship training was evaluated to determine possible correlations. Results: A kappa coefficient of 0.512 indicated moderate reliability between surgeons using the Snyder classification to describe partial-thickness rotator cuff tears. The mean correct score was 80%, which indicated “very good” agreement. There was no correlation between the number of shoulder arthroscopies performed per year and fellowship training and the number of correct scores. Conclusion: The Snyder classification system is reproducible and can be used in future research studies in analyzing the treatment options of partial rotator cuff tears. PMID:27738643

  20. Initial treatment of complete rotator cuff tear and transition to surgical treatment: systematic review of the evidence

    PubMed Central

    Abdul-Wahab, Taiceer A.; Betancourt, Jean P.; Hassan, Fadi; Thani, Saeed Al.; Choueiri, Hened; Jain, Nitin B.; Malanga, Gerard A.; Murrell, William D.; Prasad, Anil; Verborgt, Olivier

    2016-01-01

    Summary Background rotator cuff tear affects many people. Natural history, and evidence for non-operative treatment remains limited. Our objective is to assess evidence available for the efficacy and morbidity of commonly used systemic medications, physiotherapy, and injections alongside evaluating any negative long-term effects. Methods a systematic search was performed of PubMed, Cochrane, EMBASE and CINAHL dates (1 January 1960 – 1 December 2014), search terms: ‘rotator cuff tear’, ‘natural history’, ‘atraumatic’, ‘injection’, ‘physiotherapy’ or ‘physical therapy’, ‘injection’, ‘corticosteroid’, ‘PRP‘, ‘MSC’, risk of conservative treatment’, and ‘surgical indication’. Results eleven studies were included. The mean Coleman Methodology Score modified for conservative therapy is 69.21 (range 88–44) (SD 12.31). This included 2 RCTs, 7 prospective, and 2 retrospective studies. Evidence suggests it is safe to monitor symptomatic rotator cuff tears, as tear size and symptoms are not correlated with pain, function, and/or ultimate outcome. Conclusions complete rotator cuff tears may be effectively treated with injections, exercise in the short and intermediate terms respectively. Negative effect of corticosteroids on rotator cuff tissue has not been demonstrated. Timing to end conservative treatment is unknown, but likely indicated when a patient demonstrates increased weakness and loss of function not recoverable by physiotherapy. PMID:27331030

  1. Numerical analysis of stress distribution in the upper arm tissues under an inflatable cuff: Implications for noninvasive blood pressure measurement

    NASA Astrophysics Data System (ADS)

    Deng, Zhipeng; Liang, Fuyou

    2016-07-01

    An inflatable cuff wrapped around the upper arm is widely used in noninvasive blood pressure measurement. However, the mechanical interaction between cuff and arm tissues, a factor that potentially affects the accuracy of noninvasive blood pressure measurement, remains rarely addressed. In the present study, finite element (FE) models were constructed to quantify intra-arm stresses generated by cuff compression, aiming to provide some theoretical evidence for identifying factors of importance for blood pressure measurement or explaining clinical observations. Obtained results showed that the simulated tissue stresses were highly sensitive to the distribution of cuff pressure on the arm surface and the contact condition between muscle and bone. In contrast, the magnitude of cuff pressure and small variations in elastic properties of arm soft tissues had little influence on the efficiency of pressure transmission in arm tissues. In particular, it was found that a thickened subcutaneous fat layer in obese subjects significantly reduced the effective pressure transmitted to the brachial artery, which may explain why blood pressure overestimation occurs more frequently in obese subjects in noninvasive blood pressure measurement.

  2. Cardiac and Vascular Responses to Thigh Cuffs and Respiratory Maneuvers on Crewmembers of the International Space Station

    NASA Technical Reports Server (NTRS)

    Hamilton, Douglas; Sargsyan, Ashot E.; Garcia, Kathleen; Ebert, Douglas; Whitson, Peggy A.; Feiveson, Alan; Alferova, Irina V.; Dulchavsky, Scott A.; Matveev, Vladimir P.; Bogomolov, Valery V.; Duncan, J. Michael

    2011-01-01

    The transition to microgravity eliminates the hydrostatic gradients in the vascular system. The resulting fluid redistribution commonly manifests as facial edema, engorgement of the external neck veins, and a decrease in leg diameter. This experiment examined the responses to modified Valsalva and Mueller maneuvers measured by cardiac and vascular ultrasound (ECHO) in a baseline steady state and during preload reduction introduced with thigh occlusion cuffs used as a counter-measure device (Braslet cuffs) measured by cardiac and vascular ultrasound examinations. Methods: Nine International Space Station crewmember subjects (Expeditions 16 - 20) were examined in 15 experiment sessions 101 +/- 46.days after launch (mean +/- SD; 33 - 185). Twenty Seven cardiac and vascular parameters were obtained with/without respiratory maneuvers before and after tightening of the Braslet cuffs. Results: Non-physicians performed diagnostic-quality cardiac and vascular ultrasound examinations using remote guidance. Three of 27 combinations of maneuvers and Braslet or Braslet alone were identified as being significant changed when compared to baseline. Eleven of 81 differences between combinations of Mueller, Valsalva or baseline were significant and related to cardiac preload reduction or increase in lower extremity venous volume. Conclusions: Acute application of Braslet occlusion cuffs causes lower extremity fluid sequestration and exerts commensurate measurable effects on cardiac performance in microgravity. Ultrasound techniques to measure the hemodynamic effects of thigh cuffs in combination with respiratory maneuvers may serve as an invaluable tool in determining the volume status of the cardiac patient at the 'microgravity bedside'.

  3. Effects of retractor application on cuff pressure and vocal cord function in patients undergoing anterior cervical discectomy and fusion.

    PubMed

    Garg, Rakesh; Rath, Girija P; Bithal, Parmod K; Prabhakar, Hemanshu; Marda, Manish K

    2010-07-01

    Anterior cervical discectomy and fusion is a commonly performed procedure for prolapse of cervical intervertebral disc. It involves retraction of soft tissue of neck for adequate exposure of anterior spinal canal. Increased cuff pressure with retractor application may affect the postoperative vocal cord function. Cuff pressures of tracheal tube were measured continuously in 37 patients using air-filled pressure transducer connected to the pilot balloon. Changes of pressure from baseline values were noted after application of cervical retractor. At the end of procedure, vocal cord movement was observed using fibreoptic bronchoscope. Significant increase in cuff pressure (168% of baseline values) and airway pressure of tracheal tube during cervical retraction was observed. The vocal cord function was assessed using fibreoptic laryngoscope. One patient developed right vocal cord palsy (2.7%) and two patients had postoperative hoarseness of voice (5.4%). All these complications improved over a period of time. It is suggested that the cuff of tracheal tube should be inflated to achieve 'just seal', with adequate cuff pressure monitoring. Intermittent release of cervical retraction may help to prevent laryngeal morbidities.

  4. Effects of retractor application on cuff pressure and vocal cord function in patients undergoing anterior cervical discectomy and fusion

    PubMed Central

    Garg, Rakesh; Rath, Girija P; Bithal, Parmod K; Prabhakar, Hemanshu; Marda, Manish K

    2010-01-01

    Anterior cervical discectomy and fusion is a commonly performed procedure for prolapse of cervical intervertebral disc. It involves retraction of soft tissue of neck for adequate exposure of anterior spinal canal. Increased cuff pressure with retractor application may affect the postoperative vocal cord function. Cuff pressures of tracheal tube were measured continuously in 37 patients using air-filled pressure transducer connected to the pilot balloon. Changes of pressure from baseline values were noted after application of cervical retractor. At the end of procedure, vocal cord movement was observed using fibreoptic bronchoscope. Significant increase in cuff pressure (168% of baseline values) and airway pressure of tracheal tube during cervical retraction was observed. The vocal cord function was assessed using fibreoptic laryngoscope. One patient developed right vocal cord palsy (2.7%) and two patients had postoperative hoarseness of voice (5.4%). All these complications improved over a period of time. It is suggested that the cuff of tracheal tube should be inflated to achieve ‘just seal’, with adequate cuff pressure monitoring. Intermittent release of cervical retraction may help to prevent laryngeal morbidities. PMID:20882169

  5. An MRI-based leg model used to simulate biomechanical phenomena during cuff algometry: a finite element study.

    PubMed

    Manafi-Khanian, Bahram; Arendt-Nielsen, Lars; Graven-Nielsen, Thomas

    2016-03-01

    Cuff pressure stimulation is applicable for assessing deep-tissue pain sensitivity by exciting a variety of deep-tissue nociceptors. In this study, the relative transfer of biomechanical stresses and strains from the cuff via the skin to the muscle and the somatic tissue layers around bones were investigated. Cuff pressure was applied on the lower leg at three different stimulation intensities (mild pressure to pain). Three-dimensional finite element models including bones and three different layers of deep tissues were developed based on magnetic resonance images (MRI). The skin indentation maps at mild pressure, pain threshold, and intense painful stimulations were extracted from MRI and applied to the model. The mean stress under the cuff position around tibia was 4.6, 4.9 and around fibula 14.8, 16.4 times greater than mean stress of muscle surface in the same section at pain threshold and intense painful stimulations, respectively. At the same stimulation intensities, the mean strains around tibia were 36.4, 42.3 % and around fibula 32.9, 35.0 %, respectively, of mean strain on the muscle surface. Assuming strain as the ideal stimulus for nociceptors the results suggest that cuff algometry is less capable to challenge the nociceptors of tissues around bones as compared to more superficially located muscles.

  6. Posterior rotator cuff strengthening using theraband(r) in a functional diagonal pattern in collegiate baseball pitchers.

    PubMed

    Page, P A; Lamberth, J; Abadie, B; Boling, R; Collins, R; Linton, R

    1993-01-01

    The deceleration phase of the pitching mechanism requires forceful eccentric contraction of the posterior rotator cuff. Because traditional isotonic strengthening may not be specific to this eccentric pattern, a more effective and functional means of strengthening the posterior rotator cuff is needed. Twelve collegiate baseball pitchers performed a moderate intensity isotonic dumbbell strengthening routine for 6 weeks. Six of the 12 subjects were randomly assigned to an experimental group and placed on a Theraband(R) Elastic Band strengthening routine in a functional-diagonal pattern to emphasize the eccentric contraction of the posterior rotator cuff, in addition to the isotonic routine. The control group (n = 6) performed only the isotonic exercises. Both groups were evaluated on a KIN-COM(R) isokinetic dynamometer in a functional diagonal pattern. Pretest and posttest average eccentric force production of the posterior rotator cuff was compared at two speeds, 60 and 180 degrees /s. Data were analyzed with an analysis of covariance at the .05 level with significance at 60 degrees /s. Values at 180 degrees /s, however, were not significant. Eccentric force production at 60 degrees /s increased more during training in the experimental group (+19.8%) than in the control group (-1.6%). There was no difference in the two groups at 180 degrees /s; both decreased (8 to 15%). Theraband was effective at 60 degrees /s in functional eccentric strengthening of the posterior rotator cuff in the pitching shoulder.

  7. The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola.

    PubMed

    2015-07-27

    A World Health Organization expert meeting on Ebola vaccines proposed urgent safety and efficacy studies in response to the outbreak in West Africa. One approach to communicable disease control is ring vaccination of individuals at high risk of infection due to their social or geographical connection to a known case. This paper describes the protocol for a novel cluster randomised controlled trial design which uses ring vaccination.In the Ebola ça suffit ring vaccination trial, rings are randomised 1:1 to (a) immediate vaccination of eligible adults with single dose vaccination or (b) vaccination delayed by 21 days. Vaccine efficacy against disease is assessed in participants over equivalent periods from the day of randomisation. Secondary objectives include vaccine effectiveness at the level of the ring, and incidence of serious adverse events. Ring vaccination trials are adaptive, can be run until disease elimination, allow interim analysis, and can go dormant during inter-epidemic periods.

  8. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD

    PubMed Central

    Khindri, Sanjeev; Vahdati-Bolouri, Mitra; Church, Alison; Fahy, William A.

    2016-01-01

    This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease. This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0–24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score). Adverse events were also assessed. A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: −50 mL) to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: −5–54). Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37%) and glycopyrronium (36%). Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments. PMID:27730198

  9. Functional Outcomes After Double-Row Versus Single-Row Rotator Cuff Repair

    PubMed Central

    Nicholas, Stephen J.; Lee, Steven J.; Mullaney, Michael J.; Tyler, Timothy F.; Fukunaga, Takumi; Johnson, Christopher D.; McHugh, Malachy P.

    2016-01-01

    Background: The functional benefits of double-row (DR) versus single-row (SR) rotator cuff repair are not clearly established. Purpose: To examine the effect of DR versus SR rotator cuff repair on functional outcomes and strength recovery in patients with full-thickness tears. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-nine patients were randomized to DR or SR repairs; 36 patients (13 women, 23 men; mean age, 62 ± 7 years; 20 SR, 16 DR) were assessed at a mean 2.2 ± 1.6 years after surgery (range, 1-7 years; tear size: 17 medium, 13 large, 9 massive). The following data were recorded prior to surgery and at follow-up: Penn shoulder score, American Shoulder and Elbow Surgeons (ASES), and Simple Shoulder Test (SST) results; range of motion (ROM) for shoulder flexion, external rotation (ER) at 0° and 90° of abduction, and internal rotation (IR) at 90° of abduction; and shoulder strength (Lafayette manual muscle tester) in empty- and full-can tests, abduction, and ER at 0° of abduction. Treatment (SR vs DR) × time (pre- vs postoperative) mixed-model analysis of variance was used to assess the effect of rotator cuff repair. Results: Rotator cuff repair markedly improved Penn, ASES, and SST scores (P < .001), with similar improvement between SR and DR repairs (treatment × time, P = .38-.10) and excellent scores at follow-up (DR vs SR: Penn, 91 ± 11 vs 92 ± 11 [P = .73]; ASES, 87 ± 12 vs 92 ± 12 [P = .21]; SST, 11.4 ± 1.0 vs 11.3 ± 1.0 [P = .76]). Patients with DR repairs lost ER ROM at 0° of abduction (preoperative to final follow-up, 7° ± 10° loss [P = .013]). ER ROM did not significantly change with SR repair (5° ± 14° gain, P = .16; treatment by time, P = .008). This effect was not apparent for ER ROM at 90° of abduction (treatment × time, P = .26). IR ROM improved from preoperative to final follow-up (P < .01; SR, 17° ± 27°; DR, 7° ± 21°; treatment × time, P = .23). Rotator cuff repair markedly

  10. The prevalence of neovascularity in patients clinically diagnosed with rotator cuff tendinopathy

    PubMed Central

    2009-01-01

    Background Shoulder dysfunction is common and pathology of the rotator cuff tendons and subacromial bursa are considered to be a major cause of pain and morbidity. Although many hypotheses exist there is no definitive understanding as to the origin of the pain arising from these structures. Research investigations from other tendons have placed intra-tendinous neovascularity as a potential mechanism of pain production. The prevalence of neovascularity in patients with a clinical diagnosis of rotator cuff tendinopathy is unknown. As such the primary aim of this pilot study was to investigate if neovascularity could be identified and to determine the prevalence of neovascularity in the rotator cuff tendons and subacromial bursa in subjects with unilateral shoulder pain clinically assessed to be rotator cuff tendinopathy. The secondary aims were to investigate the association between the presence of neovascularity and pain, duration of symptoms, and, neovascularity and shoulder function. Methods Patients with a clinical diagnosis of unilateral rotator cuff tendinopathy referred for a routine diagnostic ultrasound (US) scan in a major London teaching hospital formed the study population. At referral patients were provided with an information document. On the day of the scan (on average, at least one week later) the patients agreeing to participate were taken through the consent process and underwent an additional clinical examination prior to undergoing a bilateral grey scale and colour Doppler US examination (symptomatic and asymptomatic shoulder) using a Philips HDI 5000 Sono CT US machine. The ultrasound scans were performed by one of two radiologists who recorded their findings and the final assessment was made by a third radiologist blinded both to the clinical examination and the ultrasound examination. The findings of the radiologists who performed the scans and the blinded radiologist were compared and any disagreements were resolved by consensus. Results

  11. Massive rotator cuff tear associated with acute traumatic posterior shoulder dislocation: report of two cases and literature review.

    PubMed

    Luenam, Suriya; Kosiyatrakul, Arkaphat

    2013-12-01

    A massive rotator cuff tear in association with acute traumatic posterior glenohumeral dislocation is rare. To our knowledge, only four documented cases have been reported in the literature. We present two additional cases of such injury secondary to the traffic accident. The first patient had an unsuccessful closed reduction due to the posterior instability while the second developed the profound shoulder weakness following the reduction. From the findings of our cases together with the previous reports, every patient had a unique injury mechanism of high-energy directed axial loading on an outstretched, adducted, and internally rotated arm. The glenohumeral capsule and rotator cuff were uniformly avulsed from the humeral attachment, and the supraspinatus and infraspinatus were always involved. However, the clinical presentations were variable based on the severity of the associated rotator cuff tear. The outcomes of operative treatment in this type of injury with the open repair were favorable. PMID:22782426

  12. Latissimus dorsi tendon transfer for irreparable postero-superior cuff tears: current concepts, indications, and recent advances.

    PubMed

    Grimberg, Jean; Kany, Jean

    2014-03-01

    Latissimus dorsi tendon transfer is a method for surgical treatment of massive irreparable posterosuperior cuff tears. It partially restores active anteflexion, external rotation, and function of the shoulder but does not significantly increase strength of the shoulder. It is contraindicated in case of pseudoparalytic shoulder; associated irreparable subscapularis tear, deltoid palsy, and in case of associated osteoarthritis, as an isolated procedure. Results are inferior when performed as a secondary procedure compared with a primary procedure. However, latissimus dorsi tendon transfer is an attractive solution to improve shoulder mobility and function of young and non osteoarthritic patients whose previous surgical treatment of massive postero-superior irreparable rotator cuff tear failed. As a primary procedure, latissimus dorsi tendon transfer competes with debridement, biceps tenotomy, and partial cuff repair. In association with reverse shoulder arthroplasty, it restores active external rotation in osteoarthritic patients with active external rotation deficit. New arthroscopic assisted techniques might improve results in the future.

  13. A larger critical shoulder angle requires more rotator cuff activity to preserve joint stability.

    PubMed

    Viehöfer, Arnd F; Gerber, Christian; Favre, Philippe; Bachmann, Elias; Snedeker, Jess G

    2016-06-01

    Shoulders with rotator cuff tears (RCT) tears are associated with significantly larger critical shoulder angles (CSA) (RCT CSA = 38.2°) than shoulders without RCT (CSA = 32.9°). We hypothesized that larger CSAs increase the ratio of glenohumeral joint shear to joint compression forces, requiring substantially increased compensatory supraspinatus loads to stabilize the arm in abduction. A previously established three dimensional (3D) finite element (FE) model was used. Two acromion shapes mimicked the mean CSA of 38.2° found in patients with RCT and that of a normal CSA (32.9°). In a first step, the moment arms for each muscle segment were obtained for 21 different thoracohumeral abduction angles to simulate a quasi-static abduction in the scapular plane. In a second step, the muscle forces were calculated by minimizing the range of muscle stresses able to compensate an external joint moment caused by the arm weight. If the joint became unstable, additional force was applied by the rotator cuff muscles to restore joint stability. The model showed a higher joint shear to joint compressive force for the RCT CSA (38.2°) for thoracohumeral abduction angles between 40° and 90° with a peak difference of 23% at 50° of abduction. To achieve stability in this case additional rotator cuff forces exceeding physiological values were required. Our results document that a higher CSA tends to destabilize the glenohumeral joint such that higher than normal supraspinatus forces are required to maintain modeled stability during active abduction. This lends strong support to the concept that a high CSA can induce supraspinatus (SSP) overload. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:961-968, 2016. PMID:26572231

  14. Low-term results from non-conventional partial arthroplasty for treating rotator cuff arthroplasthy☆

    PubMed Central

    Tenor Júnior, Antônio Carlos; de Lima, José Alano Benevides; de Vasconcelos, Iúri Tomaz; da Costa, Miguel Pereira; Filho, Rômulo Brasil; Ribeiro, Fabiano Rebouças

    2015-01-01

    Objective To evaluate the evolution of the functional results from CTA® hemiarthroplasty for surgically treating degenerative arthroplathy of the rotator cuff, with a mean follow-up of 5.4 years. Methods Eighteen patients who underwent CTA® partial arthroplasty to treat degenerative arthroplathy of the rotator cuff between April 2007 and June 2009 were reevaluated, with minimum and mean follow-ups of 4.6 years and 5.4 years, respectively. Pre and postoperative parameters for functionality and patient satisfaction were used (functional scale of the University of California in Los Angeles, UCLA). All the patients underwent prior conservative treatment for 6 months and underwent surgical treatment because of the absence of satisfactory results. Patients were excluded if they presented any of the following: previous shoulder surgery; pseudoparalysis; insufficiency of the coracoacromial arch (type 2 B in Seebauer's classification); neurological lesions; or insufficiency of the deltoid muscle and the subscapularis muscle. Results With a mean follow-up of 5.4 years, 14 patients considered that they were satisfied with the surgery (78%); the mean range of joint motion for active elevation improved from 55.8° before the operation to 82.0° after the operation; the mean external rotation improved from 18.9° before the operation to 27.3° after the operation; and the mean medial rotation remained at the level of the third lumbar vertebra. The mean UCLA score after the mean follow-up of 5.4 years was 23.94 and this was an improvement in comparison with the preoperative mean and the mean 1 year after the operation. Conclusion The functional results from CTA® hemiarthroplasty for treating rotator cuff arthroplasty in selected patients remained satisfactory after a mean follow-up of 5.4 years. PMID:26229938

  15. Design, fabrication and evaluation of a conforming circumpolar peripheral nerve cuff electrode for acute experimental use.

    PubMed

    Foldes, Emily L; Ackermann, D Michael; Bhadra, Niloy; Kilgore, Kevin L; Bhadra, Narendra

    2011-03-15

    Nerve cuff electrodes are a principle tool of basic and applied electro-neurophysiology studies and are championed for their ability to achieve good nerve recruitment with low thresholds. We describe the design and method of fabrication for a novel circumpolar peripheral nerve electrode for acute experimental use. This cylindrical cuff-style electrode provides approximately 270° of radial electrode contact with a nerve for each of an arbitrary number of contacts, has a profile that allows for simple placement and removal in an acute nerve preparation, and is designed for adjustment of the cylindrical diameter to ensure a close fit on the nerve. For each electrode, the electrical contacts were cut from 25 μm platinum foil as an array so as to maintain their positions relative to each other within the cuff. Lead wires were welded to each intended contact. The structure was then molded in silicone elastomer, after which the individual contacts were electrically isolated. The final electrode was curved into a cylindrical shape with an inner diameter corresponding to that of the intended target nerve. The positions of these contacts were well maintained during the molding and shaping process and failure rates during fabrication due to contact displacements were very low. Established electrochemical measurements were made on one electrode to confirm expected behavior for a platinum electrode and to measure the electrode impedance to applied voltages at different frequencies. These electrodes have been successfully used for nerve stimulation, recording, and conduction block in a number of different acute animal experiments by several investigators.

  16. PLATELET-RICH PLASMA IN ARTHROSCOPIC REPAIRS OF COMPLETE TEARS OF THE ROTATOR CUFF

    PubMed Central

    Malavolta, Eduardo Angeli; Gracitelli, Mauro Emilio Conforto; Sunada, Edwin Eiji; Benegas, Eduardo; de Santis Prada, Flavia; Neto, Raul Bolliger; Rodrigues, Marcelo Bordalo; Neto, Arnaldo Amado Ferreira; de Camargo, Olavo Pires

    2015-01-01

    Objective: To evaluate shoulder functional results and the retear rate of arthroscopic repair of the rotator cuff augmented with platelet-rich plasma (PRP).Methods: Prospective case series with single-row arthroscopic repair of the rotator cuff augmented with PRP. Only cases of isolated supraspinatus tears with retraction of less than 3 cm were included in this series. The PRP used was obtained by apheresis. It was applied on liquid consistency in its activated form, with the addition of autologous thrombin. Patients were evaluated after 12 months of the surgical procedure. The Constant-Murley, UCLA and VAS scales were used, and the retear rate was assessed using magnetic resonance imaging (MRI). Results: Fourteen patients were evaluated (14 shoulders). The mean Constant-Murley score was 45.64 ± 12.29 before the operation and evolved to 80.78 ± 13.22 after the operation (p < 0.001). The UCLA score increased from 13.78 ± 5.66 to 31.43 ± 3.9 (p < 0.001). The patients’ pain level decreased from a median of 7.5 (p25% = 6, p75% = 8) to 0.5 (p25% = 0, p75% = 3) (p = 0.0013) according to the VAS score. None of the patients presented complete retear. Three patients (21.4%) showed partial retear, without transfixation. Only one patient developed complications (adhesive capsulitis). Conclusion: Patients submitted to arthroscopic rotator cuff repair augmented with PRP showed significant functional improvement and none of them had complete retearing. PMID:27047894

  17. Electrochemical performance of platinum electrodes within the multi-electrode spiral nerve cuff.

    PubMed

    Rozman, Janez; Pečlin, Polona; Mehle, Andraž; Šala, Martin

    2014-09-01

    In this study, the electrochemical performance of platinum electrodes within a multi-electrode spiral cuff to be used for selective nerve stimulation was investigated. The original cuff, simplified into a half-cuff, contained a single row of nine electrodes (0.5 × 2 mm) at a distance of 2 mm from its inner surface. Cyclic voltammetry was used to investigate the electrochemical reactions at the electrode-electrolyte interface, to define a potential window within which the electrode could be safely used in selective nerve stimulation, to calculate the charge injection capacity and cathodal charge storage capacity. Voltage transients retrieved during excitation with quasitrapezoidal biphasic current pulses, tested by selective nerve stimulation of the isolated porcine left cervical vagus nerve segment, were used to determine the maximum polarization across the electrode-electrolyte interface and to calculate cathodic charge injection capacity of the electrode. The results show that the most negative and most positive potentials across the electrode-electrolyte interface reached -0.54 and 0.59 V; these did not exceed the safe potential limits for water electrolysis. Furthermore, the time integral of the cathodic current by cyclic voltammetry measured over the potential range of water electrolysis, actually representing the cathodal charge storage capacity, was approximately -4 mC cm(-2). The charge injection capacity, representing the maximum charge density injected in a current stimulation pulse, using only reversible processes, however, was around 75 µC cm(-2). In conclusion, both, the tested stimulation pulse and electrode are suitable for efficient and safe selective nerve stimulation.

  18. PROSPECTIVE AND COMPARATIVE STUDY ON FUNCTIONAL OUTCOMES AFTER OPEN AND ARTHROSCOPIC REPAIR OF ROTATOR CUFF TEARS

    PubMed Central

    de Castro Veado, Marco Antônio; Castilho, Rodrigo Simões; Maia, Philipe Eduardo Carvalho; Rodrigues, Alessandro Ulhôa

    2015-01-01

    Objective: To prospectively assess the surgical results from patients undergoing repairs to rotator cuff injuries via open and arthroscopic procedures, with regard to functional and clinical features, and by means of ultrasound examinations, and to compare occurrences of renewed tearing. Methods: Sixty patients underwent operations performed by the same surgeon (29 via open surgery and 31 via arthroscopy), to repair complete rotator cuff tears. The procedures were performed at Hospital Governor Israel Pinheiro (HGIP) and Mater Dei Hospital in Belo Horizonte, Minas Gerais, between August 2007 and February 2009. The patients were assessed functionally by means of the UCLA score before and after the operation, and magnetic resonance imaging was done before the operation. All the patients were reassessed at least 12 months after the operation, and an ultrasound examination was also performed at this time. Results: Out of the 29 patients who underwent open surgery, 27 (93.1%) presented good or excellent results, with a mean UCLA score of 32 after the operation. Their mean follow-up was 14 months. Three patients presented renewed tearing on ultrasound, of whom one remained asymptomatic. Out of the 31 patients who underwent arthroscopic procedures, 29 (93.5%) presented good or excellent results, with a mean UCLA score of 33 after the operation. Their mean follow-up was 19 months. Two patients presented renewed tearing, of whom one remained asymptomatic and one evolved with loosening of an anchor, with an unsatisfactory result. Conclusion: The repairs on rotator cuff injuries presented good results by means of both open surgery and arthroscopy, with similar functional results in the two groups and similar rates of renewed tearing. PMID:27027052

  19. Imaging of the rotator cuff following repair: human and animal models.

    PubMed

    Potter, Hollis G; Jawetz, Shari T; Foo, Li Foong

    2007-01-01

    Imaging of the rotator cuff following repair may be challenging due to the type of fixation, surgical manipulation of the tissue and the presence of residual defects that may exist in the presence of good functional outcome. Both ultrasound and magnetic resonance (MR) imaging present unique advantages in evaluation of the postoperative tissue. MR imaging has superior soft tissue contrast and provides a more global shoulder assessment, including the degree of arthrosis, while ultrasound enables a more dynamic testing of the repaired tissue. Power Doppler ultrasound and new contrast agents provide insight into the degree of vascular recruitment following repair.

  20. Deltoid muscle shape analysis with magnetic resonance imaging in patients with chronic rotator cuff tears

    PubMed Central

    2013-01-01

    Background It seems appropriate to assume, that for a full and strong global shoulder function a normally innervated and active deltoid muscle is indispensable. We set out to analyse the size and shape of the deltoid muscle on MR-arthrographies, and analyse its influence on shoulder function and its adaption (i.e. atrophy) for reduced shoulder function. Methods The fatty infiltration (Goutallier stages), atrophy (tangent sign) and selective myotendinous retraction of the rotator cuff, as well as the thickness and the area of seven anatomically defined segments of the deltoid muscle were measured on MR-arthrographies and correlated with shoulder function (i.e. active abduction). Included were 116 patients, suffering of a rotator cuff tear with shoulder mobility ranging from pseudoparalysis to free mobility. Kolmogorov-Smirnov test was used to determine the distribution of the data before either Spearman or Pearson correlation and a multiple regression was applied to reveal the correlations. Results Our developed method for measuring deltoid area and thickness showed to be reproducible with excellent interobserver correlations (r = 0.814–0.982). The analysis of influencing factors on active abduction revealed a weak influence of the amount of SSP tendon (r = −0.25; p < 0.01) and muscle retraction (r = −0.27; p < 0.01) as well as the stage of fatty muscle infiltration (GFDI: r = −0.36; p < 0.01). Unexpectedly however, we were unable to detect a relation of the deltoid muscle shape with the degree of active glenohumeral abduction. Furthermore, long-standing rotator cuff tears did not appear to influence the deltoid shape, i.e. did not lead to muscle atrophy. Conclusions Our data support that in chronic rotator cuff tears, there seems to be no disadvantage to exhausting conservative treatment and to delay implantation of reverse total shoulder arthroplasty, as the shape of deltoid muscle seems only to be influenced by natural aging

  1. Panax ginseng in randomised controlled trials: a systematic review.

    PubMed

    Shergis, Johannah L; Zhang, Anthony L; Zhou, Wenyu; Xue, Charlie C

    2013-07-01

    Panax ginseng C.A. Meyer is a common herb with many purported health benefits. However, there is no conclusive evidence supporting its use in the treatment of any particular disease. We conducted a systematic review to evaluate randomised controlled trials. Four English databases were searched with no publication date restriction. Included studies evaluated P. ginseng in patients with any type of disease or in healthy individuals. We assessed the quality of studies using the Cochrane risk of bias tool. Of the 475 potentially relevant studies, 65 met the inclusion criteria. These studies examined P. ginseng's effects on psychomotor performance (17 studies), physical performance (ten), circulatory system (eight), glucose metabolism (six), the respiratory system (five), erectile dysfunction (four), immunomodulation (four), quality of life/mood (four), antioxidant function (two), cancer (two), menopausal symptoms (two) and dry mouth (one). The risk of bias was unclear in most studies. Authors evaluated adverse events in 40 studies, with 135 minor events and no serious adverse events reported. P. ginseng shows promising results for improving glucose metabolism and moderating the immune response. This may have implications for several diseases including type 2 diabetes and chronic respiratory conditions. Further studies are needed to explore P. ginseng's potential as an effective treatment for these and other health conditions.

  2. Mendelian randomisation: a tool for assessing causality in observational epidemiology.

    PubMed

    Sheehan, Nuala A; Meng, Sha; Didelez, Vanessa

    2011-01-01

    Detection and assessment of the effect of a modifiable risk factor on a disease with view to informing public health intervention policies are of fundamental concern in aetiological epidemiology. In order to have solid evidence that such a public health intervention has the desired effect, it is necessary to ascertain that an observed association or correlation between a risk factor and a disease means that the risk factor is causal for the disease. Inferring causality from observational data is difficult, typically due to confounding by social, behavioural, or physiological factors which are difficult to control for and particularly difficult to measure accurately. A possible approach to inferring causality when confounding is believed to be present but unobservable, as it may not even be fully understood, is based on the method of instrumental variables and is known under the name of Mendelian randomisation if the instrument is a genetic variant. While testing for the presence of a causal effect using this method is generally straightforward, point estimates of such an effect are only obtainable under additional parametric assumptions. This chapter introduces the concept and illustrates the method and its assumptions with simple real-life examples. It concludes with a brief discussion on pitfalls and limitations.

  3. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    ERIC Educational Resources Information Center

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  4. Stem cell therapy in the management of shoulder rotator cuff disorders.

    PubMed

    Valencia Mora, Maria; Ruiz Ibán, Miguel A; Díaz Heredia, Jorge; Barco Laakso, Raul; Cuéllar, Ricardo; García Arranz, Mariano

    2015-05-26

    Rotator cuff tears are frequent shoulder problems that are usually dealt with surgical repair. Despite improved surgical techniques, the tendon-to-bone healing rate is unsatisfactory due to difficulties in restoring the delicate transitional tissue between bone and tendon. It is essential to understand the molecular mechanisms that determine this failure. The study of the molecular environment during embryogenesis and during normal healing after injury is key in devising strategies to get a successful repair. Mesenchymal stem cells (MSC) can differentiate into different mesodermal tissues and have a strong paracrine, anti-inflammatory, immunoregulatory and angiogenic potential. Stem cell therapy is thus a potentially effective therapy to enhance rotator cuff healing. Promising results have been reported with the use of autologous MSC of different origins in animal studies: they have shown to have better healing properties, increasing the amount of fibrocartilage formation and improving the orientation of fibrocartilage fibers with less immunologic response and reduced lymphocyte infiltration. All these changes lead to an increase in biomechanical strength. However, animal research is still inconclusive and more experimental studies are needed before human application. Future directions include expanded stem cell therapy in combination with growth factors or different scaffolds as well as new stem cell types and gene therapy.

  5. Antioxidant's cytoprotective effects on rotator cuff tenofibroblasts exposed to aminoamide local anesthetics.

    PubMed

    Kim, Ra Jeong; Hah, Young-Sool; Kang, Jae-Ran; Park, Hyung Bin

    2015-07-01

    Local anesthetics (LA) are among the drugs most frequently used for musculoskeletal problems, in procedures ranging from diagnosis to postoperative pain control. The cytotoxicity of LA is an emerging area of concern. The purpose of this study was to determine whether cyanidin, an antioxidant, exerts cytoprotective effects against tenofibroblast death induced by LA. Primary cultured human rotator cuff tenofibroblasts were used to evaluate the cytotoxicity of these LA: Ropivacaine (0.075%), Bupivacaine (0.05%), and Lidocaine (0.2%). The effects of cyanidin (100 μg/ml) on the cytotoxicity induced by these LA were investigated. Cell viability, ROS production, caspase-3/7 activity, and expressions of phospho-extracellular signal-regulated kinases (ERK), phospho-p38, phospho-c-Jun N-terminal kinase (JNK), and cleaved PARP-1 were evaluated. Exposure to LA significantly induced cell death (p < 0.001), ROS production (p ≤ 0.04), the activation of caspase-3/7 (p < 0.001), and the increased expressions of phospho-ERK, phospho-p38, phospho-JNK, and cleaved PARP-1. These LA-induced cytotoxic effects were reduced by cyanidin. These data indicate that cyanidin, an antioxidant, has cytoprotective effects against LA-induced cytotoxicity to rotator cuff tenofibroblasts. PMID:25639557

  6. Stem cell therapy in the management of shoulder rotator cuff disorders.

    PubMed

    Valencia Mora, Maria; Ruiz Ibán, Miguel A; Díaz Heredia, Jorge; Barco Laakso, Raul; Cuéllar, Ricardo; García Arranz, Mariano

    2015-05-26

    Rotator cuff tears are frequent shoulder problems that are usually dealt with surgical repair. Despite improved surgical techniques, the tendon-to-bone healing rate is unsatisfactory due to difficulties in restoring the delicate transitional tissue between bone and tendon. It is essential to understand the molecular mechanisms that determine this failure. The study of the molecular environment during embryogenesis and during normal healing after injury is key in devising strategies to get a successful repair. Mesenchymal stem cells (MSC) can differentiate into different mesodermal tissues and have a strong paracrine, anti-inflammatory, immunoregulatory and angiogenic potential. Stem cell therapy is thus a potentially effective therapy to enhance rotator cuff healing. Promising results have been reported with the use of autologous MSC of different origins in animal studies: they have shown to have better healing properties, increasing the amount of fibrocartilage formation and improving the orientation of fibrocartilage fibers with less immunologic response and reduced lymphocyte infiltration. All these changes lead to an increase in biomechanical strength. However, animal research is still inconclusive and more experimental studies are needed before human application. Future directions include expanded stem cell therapy in combination with growth factors or different scaffolds as well as new stem cell types and gene therapy. PMID:26029341

  7. All-Suture Transosseous Repair for Rotator Cuff Tear Fixation Using Medial Calcar Fixation

    PubMed Central

    Aramberri-Gutiérrez, Mikel; Martínez-Menduiña, Amaia; Valencia-Mora, María; Boyle, Simon

    2015-01-01

    We describe an all-suture transosseous repair technique used in the management of rotator cuff tears by means of an all-suture anchor secured on the intra-articular side of the humeral calcar. The technique uses an anterior cruciate ligament guide to ensure accurate positioning of the tunnels, avoiding the articular cartilage and minimizing risk to the neurovascular structures. The distal end of the guide is inserted through a rotator interval portal and passed down to the axillary pouch. The proximal end of the guide is approximated to the greater tuberosity at the cuff footprint, and a complete transosseous tunnel is created with a 2.4-mm drill. An all-suture implant is inserted through this tunnel down to the calcar, and its deployment is visualized under arthroscopy. Gentle traction is applied to the anchor, resulting in a 4-mm concertina of the suture anchor that rests opposed to the medial cortex. The major advantage of this technique is the fixation strength gained from the biomechanically superior cortical bone of the calcar. Furthermore, this method permits greater preservation of bone surface area at the level of the footprint for a larger tendon-to-bone healing surface. This technique also provides an excellent alternative in revision situations. PMID:26052495

  8. Numerical validation of a suprasystolic brachial cuff-based method for estimating aortic pressure.

    PubMed

    Liang, Fuyou

    2014-01-01

    Central aortic pressures are better predictors of cardiovascular events than peripheral pressures. However, central aortic blood pressures cannot be measured noninvasively; for this reason, estimating aortic pressures from noninvasive measurements of peripheral pressures has been the subject of numerous studies. In the present study, a novel method was proposed to noninvasively estimate aortic pressures from the oscillometric wave of a suprasystolic brachial cuff. The errors of estimation were evaluated in relation to various cardiovascular properties using an integrated cardiovascular-cuff model. Obtained results demonstrated that the estimation errors are affected mainly by aortic stiffness. The estimation errors for aortic systolic pressure, diastolic pressure, pulse pressure and wave shape under the assumed cardiovascular conditions were 5.84 ± 1.58 mmHg, -0.28 ± 0.41 mmHg, 6.12 ± 1.42 mmHg and 1.72 ± 0.57 mmHg, respectively, all of which fell within the error ranges established by existing devices. Since the method is easy to be automated and bases the estimation fully on patient-specific information, its clinical application is promising, although further clinical studies are awaited to validate the method in vivo.

  9. RADIOGRAPHIC STUDY ON THE ACROMION INDEX AND ITS RELATIONSHIP WITH ROTATOR CUFF TEARS

    PubMed Central

    Miyazaki, Alberto Naoki; Fregoneze, Marcelo; Santos, Pedro Doneux; Da Silva, Luciana Andrade; Menegassi Martel, Éder; Debom, Leandro Gervazoni; Andrade, Manoel Loyola; Checchia, Sérgio Luiz

    2015-01-01

    Objective: The purpose of this study was to evaluate the relationship between the lateral projection of the acromion and rotator cuff tears (RCTs) in the Brazilian population. Methods: The lateral projection of the acromion was measured using anteroposterior radiographs of the shoulders, carried out with the glenoid cavity in absolute profile and the humeral head in the neutral position or with internal rotation. The acromion index (AI) was defined as the ratio between the distance from the plane of the glenoid cavity to the lateral edge of the acromion and the distance from the plane of the glenoid cavity to the lateral edge of the humeral head. This index was measured in 83 patients (mean age of 54 years) with RCTs and compared with a group of 28 individuals (mean age of 48 years) without RCTs. The presence or absence of RCTs was determined by means of magnetic resonance imaging. Results: The mean AI was 0.7194 for the patients with RCTs and 0.6677 for the individuals without RCTs, in the Brazilian population. This difference was statistically significant, with P < 0.001. Conclusion: A relationship can be established between AI and rotator cuff tears in the Brazilian population. PMID:27022534

  10. Assessment of the canine model of rotator cuff injury and repair

    PubMed Central

    Derwin, Kathleen A; Baker, Andrew R; Codsi, Michael J; Iannotti, Joseph P

    2007-01-01

    Animal shoulder models are used to systematically investigate the factors influencing rotator cuff injury and repair. Each model has advantages and disadvantages that must be considered in the context of the specific research questions being asked. Herein we evaluate the utility of the canine model for studies of acute, full-thickness rotator cuff tendon injury and repair. We found that time zero failure load is dependent on the suture type and configuration used for repair. Acute, full-width tendon repairs fail anatomically within the first days after surgery in the canine model, regardless of suture type, suture configuration or post-operative protocol. Robust scar tissue forms in the gap between the failed tendon end and the humerus, which can be visually, mechanically and histologically misconstrued as tendon if an objective test of repair connectivity is not performed. We conclude that a full-width injury and repair model in the canine will provide a rigorous test of whether a new repair strategy or post-operative protocol (such as casting or temporary muscle paralysis) can maintain repair integrity in a high load environment. Alternatively, a partial-width tendon injury model allows loads to be shared between the tendon repair and the remaining intact portion of the infraspinatus tendon and prohibits complete tendon retraction. Thus a partial-width injury in the canine may model the mechanical environment of many single tendon tears in the human injury condition and warrants further investigation. PMID:17560802

  11. The Effect of Platelet-rich Fibrin Matrix on Rotator Cuff Healing in a Rat Model.

    PubMed

    Hasan, S; Weinberg, M; Khatib, O; Jazrawi, L; Strauss, E J

    2016-01-01

    The purpose of the current study was to determine if the application of platelet-rich fibrin matrix could improve regeneration of the tendon-bone insertion site in a rat rotator cuff repair model. 25 Lewis syngeneic rats underwent bilateral tenotomy and repair of the supraspinatus tendon. 10 separate rats were used for PRFM harvest. All left (control) shoulders underwent transosseous rotator cuff repair, while all right (treatment) shoulders were repaired similarly with PRFM augmentation. 9 rats were sacrificed at 2-weeks and ten at 4-weeks for biomechanical testing. 3 separate rats were sacrificed at 2-weeks and 4-weeks each for histologic analysis of the insertion site. At 2 weeks, the experimental group repairs were significantly stronger in ultimate load to failure (P=0.01), stress (P=0.03), and stiffness (P=0.03). Differences in biomechanical testing were not found between the groups at 4 weeks. Histological analysis revealed less collagen organization and cartilage formation at the insertion site in the experimental group. Semiquantitative histologic analysis confirmed our qualitative assessment of the specimens. PRFM does not recapitulate the native enthesis, but rather induces an exuberant and disordered healing response that is characterized by fibrovascular scar tissue. PMID:26509369

  12. Measurements of endotracheal tube cuff contact pressure using fibre Bragg gratings

    NASA Astrophysics Data System (ADS)

    Hernandez, F. U.; Correia, R.; Korposh, S.; Morgan, S. P.; Hayes-Gill, B. R.; James, S. W.; Evans, D.; Norris, A.

    2015-09-01

    An optical fibre Bragg grating (FBG) was used to measure local strain (due to contact pressure) at the interface of a cuffed endotracheal tube (ETT) tested in a tracheal model. The tracheal model consisted of a corrugated tube. Two FBG sensors written in a single optical fibre were attached to the outside wall of the cuff of the ETT. Intracuff endotracheal pressure was measured using a digital manometer, while the contact pressure between the model trachea and the ETT was measured using Flexiforce sensors. Changes in the Bragg wavelengths in response to the inflation of the cuff of the ETT, and concomitant pressure increase, were observed to be dependent on the location of the FBGs at the corrugations, i.e., the annular peaks and troughs of the corrugated tube. The performance of both contact pressure sensors FBG and Flexiforce suggests that FBG technology is better suited to this application as it allows the measurement of contact pressures on non-uniform surfaces such as in the tracheal model.

  13. MRI-Arthroscopic Correlation in Rotator Cuff Tendon Pathologies; A Comparison between Various Centers

    PubMed Central

    Sefidbakht, Sepideh; Momenzadeh, Omid Reza; Dehghani, Sakineh; Gerami, Hadi

    2016-01-01

    Background: Magnetic resonance imaging (MRI) has long been considered a perfect imaging study for evaluation of shoulder pathologies despite occasional discrepancies between MR reports and arthroscopic findings. In this study we aim to evaluate impact of imaging center as an indicator of image quality on accuracy of MRI reports in diagnosis of rotator cuff tendon pathologies. Methods: We reviewed MR reports of 64 patients who underwent arthroscopy in university center hospital. MRIs were done in various centers including both university-affiliated and out-centers. All studies were reported by two radiologists in consensus unaware of the arthroscopic results or previous reports. An inter-observer agreement analysis using the kappa statistics was performed to determine consistency among imaging and surgical reports. Results: Kappa values for out-centers were as follows: 0.785 for biceps, 0.469 for suscapularis, 0.846 for supraspinatus and 0.785 for infraspinatus tendons. In university centers values were 0.799 for biceps, 0.802 for suscapularis, 0.789 for supraspinatus and 0.770 for infraspinatus tendons. Conclusion: Image reporting in university centers with proficient sequences increased accuracy of diagnosis in 3/4 of evaluated features and showed subtle decreased inter-observer agreement in 1/4 of features. Uniformity of the scanners and protocols as well as evaluation on a workstation rather than hard copies cumulatively resulted in a meaningful increase in the accuracy of the same radiologists in diagnosis of rotator cuff tendon tear. PMID:27200392

  14. The Effect of Platelet-rich Fibrin Matrix on Rotator Cuff Healing in a Rat Model.

    PubMed

    Hasan, S; Weinberg, M; Khatib, O; Jazrawi, L; Strauss, E J

    2016-01-01

    The purpose of the current study was to determine if the application of platelet-rich fibrin matrix could improve regeneration of the tendon-bone insertion site in a rat rotator cuff repair model. 25 Lewis syngeneic rats underwent bilateral tenotomy and repair of the supraspinatus tendon. 10 separate rats were used for PRFM harvest. All left (control) shoulders underwent transosseous rotator cuff repair, while all right (treatment) shoulders were repaired similarly with PRFM augmentation. 9 rats were sacrificed at 2-weeks and ten at 4-weeks for biomechanical testing. 3 separate rats were sacrificed at 2-weeks and 4-weeks each for histologic analysis of the insertion site. At 2 weeks, the experimental group repairs were significantly stronger in ultimate load to failure (P=0.01), stress (P=0.03), and stiffness (P=0.03). Differences in biomechanical testing were not found between the groups at 4 weeks. Histological analysis revealed less collagen organization and cartilage formation at the insertion site in the experimental group. Semiquantitative histologic analysis confirmed our qualitative assessment of the specimens. PRFM does not recapitulate the native enthesis, but rather induces an exuberant and disordered healing response that is characterized by fibrovascular scar tissue.

  15. Functional evaluation of arthroscopic repair of rotator cuff injuries in patients with pseudoparalysis☆☆☆

    PubMed Central

    Miyazaki, Alberto Naoki; Fregoneze, Marcelo; Santos, Pedro Doneux; da Silva, Luciana Andrade; do Val Sella, Guilherme; Neto, Douglas Lobato Lopes; Muchiuti Junior, Melvis; Checchia, Sergio Luiz

    2014-01-01

    Objective to evaluate the functional result from arthroscopic repair of rotator cuff injuries in patients with pseudoparalysis, defined as incapacity to actively raise the arm above 90°, while complete passive elevation was possible. Methods we reevaluated 38 patients with a mean follow-up of 51 months (minimum of 24). We analyzed the pseudoparalysis reversion rate and the functional result obtained. Results according to the assessment criteria of the University of California in Los Angeles (UCLA), 31 (82%) patients had good and excellent results, two (5%) had fair results and five (13%) had poor results. The mean active elevation went from 39° before the operation to 139° after the operation (p < 0.05); the mean active lateral rotation went from 30° to 48° (p < 0.05) and the mean active medial rotation went from level L3 to T12 (p < 0.05). Conclusion arthroscopic repair of rotator cuff injuries produced good and excellent results in 82% of the cases and a statistically significant improvement of active range of motion, with reversion of the pseudoparalysis in 97.4% of the cases. It is therefore a good treatment option. PMID:26229796

  16. Deltoid detachment consequent to open surgical repair of massive rotator cuff tears.

    PubMed

    Gumina, S; Di Giorgio, G; Perugia, D; Postacchini, F

    2008-02-01

    Deltoid detachment is one of the complications in open rotator cuff repair. Although it is often described, the actual prevalence, time at which it occurs and the predisposing causes are still unknown. We prospectively studied 112 patients with massive rotator cuff tears with a mean age of 67. The surgical approach was performed with a lateral para-acromial incision. Clinical assessment was performed with Constant's method. Of the 112 patients, 9 (8%) had deltoid detachment. It occurred about 3 months after surgery. Of the nine patients, two underwent revision surgery for the deltoid trans-bone reattachment. At the follow-up, the patients with deltoid detachment had a mean increase of only 5.5 points in the Constant score compared to that of 16.9 obtained by the control group. Deltoid reattachment, performed on the two patients, provided a mean increase of 7 points only with respect to the post-operative control at the 4th month. Considering the unsatisfactory functional result consequent to deltoid detachment and the slight improvement obtained with the reattachment, we recommend the following: use suture thread thicker than #2, do not use a simple stitch and avoid extending acromioplasty to the lateral margin of the acromion. PMID:17410365

  17. Deltoid detachment consequent to open surgical repair of massive rotator cuff tears

    PubMed Central

    Di Giorgio, G.; Perugia, D.; Postacchini, F.

    2007-01-01

    Deltoid detachment is one of the complications in open rotator cuff repair. Although it is often described, the actual prevalence, time at which it occurs and the predisposing causes are still unknown. We prospectively studied 112 patients with massive rotator cuff tears with a mean age of 67. The surgical approach was performed with a lateral para-acromial incision. Clinical assessment was performed with Constant’s method. Of the 112 patients, 9 (8%) had deltoid detachment. It occurred about 3 months after surgery. Of the nine patients, two underwent revision surgery for the deltoid trans-bone reattachment. At the follow-up, the patients with deltoid detachment had a mean increase of only 5.5 points in the Constant score compared to that of 16.9 obtained by the control group. Deltoid reattachment, performed on the two patients, provided a mean increase of 7 points only with respect to the post-operative control at the 4th month. Considering the unsatisfactory functional result consequent to deltoid detachment and the slight improvement obtained with the reattachment, we recommend the following: use suture thread thicker than #2, do not use a simple stitch and avoid extending acromioplasty to the lateral margin of the acromion. PMID:17410365

  18. Human distal sciatic nerve fascicular anatomy: implications for ankle control using nerve-cuff electrodes.

    PubMed

    Gustafson, Kenneth J; Grinberg, Yanina; Joseph, Sheeba; Triolo, Ronald J

    2012-01-01

    The design of neural prostheses to restore standing balance, prevent foot drop, or provide active propulsion during ambulation requires detailed knowledge of the distal sciatic nerve anatomy. Three complete sciatic nerves and branches were dissected from the piriformis to each muscle entry point to characterize the branching patterns and diameters. Fascicle maps were created from serial sections of each distal terminus below the knee through the anastomosis of the tibial and common fibular nerves above the knee. Similar branching patterns and fascicle maps were observed across specimens. Fascicles innervating primary plantar flexors, dorsiflexors, invertors, and evertors were distinctly separate and functionally organized in the proximal tibial, common fibular, and distal sciatic nerves; however, fascicles from individual muscles were not apparent at these levels. The fascicular organization is conducive to selective stimulation for isolated and/or balanced dorsiflexion, plantar flexion, eversion, and inversion through a single multicontact nerve-cuff electrode. These neuroanatomical data are being used to design nerve-cuff electrodes for selective control of ankle movement and improve current lower-limb neural prostheses. PMID:22773531

  19. Computer-Aided Diagnosis of Different Rotator Cuff Lesions Using Shoulder Musculoskeletal Ultrasound.

    PubMed

    Chang, Ruey-Feng; Lee, Chung-Chien; Lo, Chung-Ming

    2016-09-01

    The lifetime prevalence of shoulder pain approaches 70%, which is mostly attributable to rotator cuff lesions such as inflammation, calcific tendinitis and tears. On clinical examination, shoulder ultrasound is recommended for the detection of lesions. However, there exists inter-operator variability in diagnostic accuracy because of differences in the experience and expertise of operators. In this study, a computer-aided diagnosis (CAD) system was developed to assist ultrasound operators in diagnosing rotator cuff lesions and to improve the practicality of ultrasound examination. The collected cases included 43 cases of inflammation, 30 cases of calcific tendinitis and 26 tears. For each case, the lesion area and texture features were extracted from the entire lesions and combined in a multinomial logistic regression classifier for lesion classification. The proposed CAD achieved an accuracy of 87.9%. The individual accuracy of this CAD system was 88.4% for inflammation, 83.3% for calcific tendinitis and 92.3% for tears. Cohen's k was 0.798. On the basis of its diagnostic performance, clinical use of this CAD technique has promise.

  20. Stem cell therapy in the management of shoulder rotator cuff disorders

    PubMed Central

    Mora, Maria Valencia; Ibán, Miguel A Ruiz; Heredia, Jorge Díaz; Laakso, Raul Barco; Cuéllar, Ricardo; Arranz, Mariano García

    2015-01-01

    Rotator cuff tears are frequent shoulder problems that are usually dealt with surgical repair. Despite improved surgical techniques, the tendon-to-bone healing rate is unsatisfactory due to difficulties in restoring the delicate transitional tissue between bone and tendon. It is essential to understand the molecular mechanisms that determine this failure. The study of the molecular environment during embryogenesis and during normal healing after injury is key in devising strategies to get a successful repair. Mesenchymal stem cells (MSC) can differentiate into different mesodermal tissues and have a strong paracrine, anti-inflammatory, immunoregulatory and angiogenic potential. Stem cell therapy is thus a potentially effective therapy to enhance rotator cuff healing. Promising results have been reported with the use of autologous MSC of different origins in animal studies: they have shown to have better healing properties, increasing the amount of fibrocartilage formation and improving the orientation of fibrocartilage fibers with less immunologic response and reduced lymphocyte infiltration. All these changes lead to an increase in biomechanical strength. However, animal research is still inconclusive and more experimental studies are needed before human application. Future directions include expanded stem cell therapy in combination with growth factors or different scaffolds as well as new stem cell types and gene therapy. PMID:26029341

  1. The CRASH trial: the first large-scale, randomised, controlled trial in head injury

    PubMed Central

    Roberts, Ian

    2001-01-01

    The global epidemic of head injuries is just beginning. Many are caused by road traffic crashes. It is estimated that, by 2020, road traffic crashes will have moved from its present position of ninth to third in the world disease burden ranking, as measured in disability adjusted life years. In developing countries, it will have moved to second. The Corticosteroid Randomisation After Significant Head Injury (CRASH) trial is a large-scale, randomised, controlled trial, among adults with head injury and impaired consciousness, of the effects of a short-term infusion of corticosteroids on death and on neurological disability. Following a successful pilot phase, which included over 1000 randomised participants, the main phase of the trial is now underway. Over the next 5 years, the trial aims to recruit a total of 20,000 patients. Such large numbers will only be possible if hundreds of doctors and nurses can collaborate in emergency departments all over the world. The trial is currently recruiting, and new collaborators are welcome to join the trial (see ). PMID:11737908

  2. Early rehabilitation affects functional outcomes and activities of daily living after arthroscopic rotator cuff repair: a case report

    PubMed Central

    Shimo, Satoshi; Sakamoto, Yuta; Tokiyoshi, Akinari; Yamamoto, Yasuhiro

    2016-01-01

    [Purpose] The effect of early rehabilitation protocols after arthroscopic rotator cuff repair is currently unknown. We examined short-term effects of early rehabilitation on functional outcomes and activities of daily living after arthroscopic rotator cuff repair. [Subject and Methods] An 82-year-old male fell during a walk, resulting in a supraspinatus tear. Arthroscopic rotator cuff repair was performed using a single-row technique. He wore an abduction brace for 6 weeks after surgery. [Results] From day 1 after surgery, passive range of motion exercises, including forward flexion and internal and external rotation were performed twice per day. Starting at 6 weeks after surgery, active range of motion exercises and muscle strengthening exercises were introduced gradually. At 6 weeks after surgery, his active forward flexion was 150°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 36 points. At 20 weeks after surgery, his active forward flexion was 120°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 0 points. [Conclusion] These protocols are recommended to physical therapists during rehabilitation for arthroscopic rotator cuff repair to support rapid reintegration into activities of daily living. PMID:27064886

  3. Are the good functional results from arthroscopic repair of massive rotator cuff injuries maintained over the long term?☆

    PubMed Central

    Miyazaki, Alberto Naoki; Santos, Pedro Doneux; da Silva, Luciana Andrade; do Val Sella, Guilherme; Checchia, Sérgio Luiz; Yonamine, Alexandre Maris

    2015-01-01

    Objective To evaluate whether the good and excellent functional results from arthroscopic repair of massive rotator cuff tears are maintained over the long term. Methods From the sample of the study conducted by our group in 2006, in which we evaluated the functional results from arthroscopic repair of massive rotator cuff tears, 35 patients were reassessed, 8 years after the first evaluation. The inclusion criteria were that these patients with massive rotator cuff tears operated by means of an arthroscopic technique, who participated in the previous study and achieved good or excellent outcomes according to the UCLA criteria. Patients whose results were not good or excellent in the first evaluation according to the UCLA criteria were excluded. Results Among the 35 patients reassessed, 91% of them continued to present good and excellent results (40% excellent and 51% good), while 3% presented fair results and 6% poor results. The time interval between the first and second evaluations was 8 years and the minimum length of follow-up since the immediate postoperative period was 9 years (range: 9–17 years), with an average of 11.4 years. Conclusion The good and excellent results from arthroscopic repair of massive rotator cuff tears were mostly maintained (91%), with the same level of function and satisfaction, even though 8 years had passed since the first assessment, with a follow-up period averaging 11.4 years. PMID:26962491

  4. Continuous and Noninvasive Recording of Cardiovascular Parameters with the Finapres Finger Cuff Enhances Undergraduate Student Understanding of Physiology

    ERIC Educational Resources Information Center

    Hodgson, Yvonne; Choate, Julia

    2012-01-01

    The Finapres finger cuff recording system provides continuous calculations of beat-to-beat variations in cardiac output (CO), total peripheral resistance, heart rate (HR), and blood pressure (BP). This system is unique in that it allows experimental subjects to immediately, continuously, and noninvasively visualize changes in CO at rest and during…

  5. Early rehabilitation affects functional outcomes and activities of daily living after arthroscopic rotator cuff repair: a case report.

    PubMed

    Shimo, Satoshi; Sakamoto, Yuta; Tokiyoshi, Akinari; Yamamoto, Yasuhiro

    2016-01-01

    [Purpose] The effect of early rehabilitation protocols after arthroscopic rotator cuff repair is currently unknown. We examined short-term effects of early rehabilitation on functional outcomes and activities of daily living after arthroscopic rotator cuff repair. [Subject and Methods] An 82-year-old male fell during a walk, resulting in a supraspinatus tear. Arthroscopic rotator cuff repair was performed using a single-row technique. He wore an abduction brace for 6 weeks after surgery. [Results] From day 1 after surgery, passive range of motion exercises, including forward flexion and internal and external rotation were performed twice per day. Starting at 6 weeks after surgery, active range of motion exercises and muscle strengthening exercises were introduced gradually. At 6 weeks after surgery, his active forward flexion was 150°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 36 points. At 20 weeks after surgery, his active forward flexion was 120°, UCLA shoulder rating scale score was 34 points, and Quick Disabilities of the Arm, Shoulder, and Hand questionnaire disability/symptom score was 0 points. [Conclusion] These protocols are recommended to physical therapists during rehabilitation for arthroscopic rotator cuff repair to support rapid reintegration into activities of daily living. PMID:27064886

  6. Systematic Review of All-Arthroscopic Versus Mini-Open Repair of Rotator Cuff Tears: A Meta-Analysis

    PubMed Central

    Huang, Rongzhong; Wang, Sanrong; Wang, Yule; Qin, Xiaoxia; Sun, Yang

    2016-01-01

    The objective of this study was to compare outcomes in patients with rotator cuff tears undergoing all-arthroscopic versus mini-open rotator cuff repair. A systematic review and meta-analysis of outcomes of all-arthroscopic repair versus mini-open repair in patients with rotator cuff repair was conducted. Studies meeting the inclusion criteria were screened and included from systematic literature search for electronic databases including Medline, Embase, Cochrane CENTRAL, and CINAHL library was conducted from 1969 and 2015. A total of 18 comparative studies including 4 randomized clinical trials (RCTs) were included. Pooled results indicate that there was no difference in the functional outcomes, range of motion, visual analog scale (VAS) score, and short-form 36 (SF-36) subscales. However, Constant-Murley functional score was found to be significantly better in patients with mini-open repair. However, the results of the review should be interpreted with caution due to small size and small number of studies contributing to analysis in some of the outcomes. All-arthroscopic and mini-open repair surgical techniques for the management of rotator cuff repair are associated with similar outcomes and can be used interchangeably based on the patient and rotator tear characteristics. PMID:26947557

  7. Comparative analysis of transverse intrafascicular multichannel, longitudinal intrafascicular and multipolar cuff electrodes for the selective stimulation of nerve fascicles

    NASA Astrophysics Data System (ADS)

    Badia, Jordi; Boretius, Tim; Andreu, David; Azevedo-Coste, Christine; Stieglitz, Thomas; Navarro, Xavier

    2011-06-01

    The selection of a suitable nerve electrode for neuroprosthetic applications implies a trade-off between invasiveness and selectivity, wherein the ultimate goal is achieving the highest selectivity for a high number of nerve fascicles by the least invasiveness and potential damage to the nerve. The transverse intrafascicular multichannel electrode (TIME) is intended to be transversally inserted into the peripheral nerve and to be useful to selectively activate subsets of axons in different fascicles within the same nerve. We present a comparative study of TIME, LIFE and multipolar cuff electrodes for the selective stimulation of small nerves. The electrodes were implanted on the rat sciatic nerve, and the activation of gastrocnemius, plantar and tibialis anterior muscles was recorded by EMG signals. Thus, the study allowed us to ascertain the selectivity of stimulation at the interfascicular and also at the intrafascicular level. The results of this study indicate that (1) intrafascicular electrodes (LIFE and TIME) provide excitation circumscribed to the implanted fascicle, whereas extraneural electrodes (cuffs) predominantly excite nerve fascicles located superficially; (2) the minimum threshold for muscle activation with TIME and LIFE was significantly lower than with cuff electrodes; (3) TIME allowed us to selectively activate the three tested muscles when stimulating through different active sites of one device, both at inter- and intrafascicular levels, whereas selective activation using multipolar cuff (with a longitudinal tripolar stimulation configuration) was only possible for two muscles, at the interfascicular level, and LIFE did not activate selectively more than one muscle in the implanted nerve fascicle.

  8. Chronic stability and selectivity of four-contact spiral nerve-cuff electrodes in stimulating the human femoral nerve

    NASA Astrophysics Data System (ADS)

    Fisher, L. E.; Tyler, D. J.; Anderson, J. S.; Triolo, R. J.

    2009-08-01

    This study describes the stability and selectivity of four-contact spiral nerve-cuff electrodes implanted bilaterally on distal branches of the femoral nerves of a human volunteer with spinal cord injury as part of a neuroprosthesis for standing and transfers. Stimulation charge threshold, the minimum charge required to elicit a visible muscle contraction, was consistent and low (mean threshold charge at 63 weeks post-implantation: 23.3 ± 8.5 nC) for all nerve-cuff electrode contacts over 63 weeks after implantation, indicating a stable interface with the peripheral nervous system. The ability of individual nerve-cuff electrode contacts to selectively stimulate separate components of the femoral nerve to activate individual heads of the quadriceps was assessed with fine-wire intramuscular electromyography while measuring isometric twitch knee extension moment. Six of eight electrode contacts could selectively activate one head of the quadriceps while selectively excluding others to produce maximum twitch responses of between 3.8 and 8.1 N m. The relationship between isometric twitch and tetanic knee extension moment was quantified, and selective twitch muscle responses scaled to between 15 and 35 N m in tetanic response to pulse trains with similar stimulation parameters. These results suggest that this nerve-cuff electrode can be an effective and chronically stable tool for selectively stimulating distal nerve branches in the lower extremities for neuroprosthetic applications.

  9. EVALUATION OF THE RESULTS FROM ARTHROSCOPIC REPAIR ON ROTATOR CUFF INJURIES AMONG PATIENTS UNDER 50 YEARS OF AGE

    PubMed Central

    Miyazaki, Alberto Naoki; Fregoneze, Marcelo; Santos, Pedro Doneux; da Silva, Luciana Andrade; do Val Sella, Guilherme; Santos, Ruy Mesquita Maranhão; de Souza, Adriano; Checchia, Sérgio Luiz

    2015-01-01

    Objective: To assess the results from arthroscopic surgical treatment of rotator cuff injuries among patients under 50 years of age. Methods: Sixty-three patients with rotator cuff injuries who underwent arthroscopic surgical treatment performed by the Shoulder and Elbow Group of the Department of Orthopedics and Traumatology, in the Fernandinho Simonsen wing of Santa Casa Medical School, São Paulo, between August 1998 and December 2007, were reassessed. The study included all patients with rotator cuff injuries who were under 50 years of age and had been followed up postoperatively for at least 24 months. Results: According to the UCLA evaluation criteria, 59 patients (92%) showed excellent and good results; five (8%) showed fair results; and none showed poor results. The postoperative evaluation showed that the mean range of motion was 145° for elevation, 47° for lateral rotation and T10 for medial rotation. Unsatisfactory results were associated with prolonged duration of the injury, with a statistically significant relationship. Conclusion: Arthroscopic repair of rotator cuff injuries in young patients produces excellent or good results for most patients. PMID:27047819

  10. Intramuscular migration of calcific tendinopathy in the rotator cuff: ultrasound appearance and a review of the literature.

    PubMed

    Becciolini, Marco; Bonacchi, Giovanni; Galletti, Stefano

    2016-09-01

    Calcific tendinopathy of the shoulder is a common condition caused by calcium hydroxyapatite crystals, affecting the tendons of the rotator cuff. Among uncommon complication, one is the migration of the calcium in the subacromion-subdeltoid bursa. More rare is the intraosseous migration. We present four cases of an even more rare condition, not well described in literature yet, the intramuscular migration of calcium.

  11. Evaluation and management of adult shoulder pain: a focus on rotator cuff disorders, acromioclavicular joint arthritis, and glenohumeral arthritis.

    PubMed

    Armstrong, April

    2014-07-01

    Shoulder pain is a common reason for a patient to see their primary care physician. This article focuses on the evaluation and management of 3 common shoulder disorders; rotator cuff disorders, acromioclavicular joint arthritis, and glenohumeral joint arthritis. The typical history and physical examination findings for each of these entities are highlighted, in addition to treatment options.

  12. HALON—hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery: a randomised controlled trial (study protocol)

    PubMed Central

    Baekelandt, Jan; De Mulder, Peter A; Le Roy, Ilse; Mathieu, Chantal; Laenen, Annouschka; Enzlin, Paul; Weyers, Steven; Mol, Ben WJ; Bosteels, Jan JA

    2016-01-01

    Introduction Natural orifice transluminal endoscopic surgery (NOTES) uses natural body orifices to access the cavities of the human body to perform surgery. NOTES limits the magnitude of surgical trauma and has the potential to reduce postoperative pain. This is the first randomised study in women bound to undergo hysterectomy for benign gynaecological disease comparing NOTES with classical laparoscopy. Methods and analysis All women aged 18–70 years, regardless of parity, consulting at our practice with an indication for hysterectomy due to benign gynaecological disease will be eligible. After stratification according to uterine size on clinical examination, participants will be randomised to be treated by laparoscopy or by transvaginal NOTES. Participants will be evaluated on day 0, days 1–7 and at 3 and 6 months. The following data will be collected: the proportion of women successfully treated by removing the uterus by the intended approach as randomised; the proportion of women admitted to the inpatient hospital; postoperative pain scores measured twice daily by the women from day 1 to 7; the total amount of analgesics used from day 1 to 7; readmission during the first 6 weeks; presence and intensity of dyspareunia and sexual well-being at baseline, 3 and 6 months (Short Sexual Functioning Scale (SSFS) scale); duration of surgery; postoperative infection or other surgical complications; direct and indirect costs incurred up to 6 weeks following surgery. The primary outcome will be the proportion of women successfully treated by the intended technique; all other outcomes are secondary. Ethics and dissemination The study was approved on 1 December 2015 by the Ethics Committee of the Imelda Hospital, Bonheiden, Belgium. The first patient was randomised on 17 December 2015. The last participant randomised should be treated before 30 November 2017. The results will be presented in peer-reviewed journals and at scientific meetings within 4

  13. Autotitrating versus standard noninvasive ventilation: a randomised crossover trial.

    PubMed

    Jaye, J; Chatwin, M; Dayer, M; Morrell, M J; Simonds, A K

    2009-03-01

    The aim of the present study was to compare the efficacy of automatic titration of noninvasive ventilation (NIV) with conventional NIV in stable neuromuscular and chest wall disorder patients established on long-term ventilatory support. In total, 20 neuromuscular and chest wall disease patients with nocturnal hypoventilation treated with long-term NIV completed a randomised crossover trial comparing two noninvasive pressure support ventilators: a standard bilevel ventilator (VPAP III) and a novel autotitrating bilevel ventilator (AutoVPAP). Baseline physiological measurements, overnight polysomnography and Holter monitoring were repeated at the end of each 1-month treatment period. Nocturnal oxygenation was comparable between the autotitrating device and standard ventilator, as were sleep efficiency, arousals and heart rate variability. However, there was a small significant increase in mean overnight transcutaneous carbon dioxide tension (median (interquartile range) 7.2 (6.7-7.7) versus 6.7 (6.1-7.0) kPa) and a decrease in percentage stage 1 sleep (mean+/-sd 16+/-9 versus 19+/-10%) on autotitrating NIV compared with conventional NIV. Autotitrating noninvasive ventilation using AutoVPAP produced comparable control of nocturnal oxygenation to standard nonivasive ventilation, without compromising sleep quality in stable neuromuscular and chest wall disease patients requiring long-term ventilatory support for nocturnal hypoventilation. PMID:19251798

  14. Model-based analysis and design of nerve cuff electrodes for restoring bladder function by selective stimulation of the pudendal nerve

    NASA Astrophysics Data System (ADS)

    Kent, Alexander R.; Grill, Warren M.

    2013-06-01

    Objective. Electrical stimulation of the pudendal nerve (PN) is being developed as a means to restore bladder function in persons with spinal cord injury. A single nerve cuff electrode placed on the proximal PN trunk may enable selective stimulation of distinct fascicles to maintain continence or evoke micturition. The objective of this study was to design a nerve cuff that enabled selective stimulation of the PN. Approach. We evaluated the performance of both flat interface nerve electrode (FINE) cuff and round cuff designs, with a range of FINE cuff heights and number of contacts, as well as multiple contact orientations. This analysis was performed using a computational model, in which the nerve and fascicle cross-sectional positions from five human PN trunks were systematically reshaped within the nerve cuff. These cross-sections were used to create finite element models, with electric potentials calculated and applied to a cable model of a myelinated axon to evaluate stimulation selectivity for different PN targets. Subsequently, the model was coupled to a genetic algorithm (GA) to identify solutions that used multiple contact activation to maximize selectivity and minimize total stimulation voltage. Main results. Simulations did not identify any significant differences in selectivity between FINE and round cuffs, although the latter required smaller stimulation voltages for target activation due to preserved localization of targeted fascicle groups. Further, it was found that a ten contact nerve cuff generated sufficient selectivity for all PN targets, with the degree of selectivity dependent on the relative position of the target within the nerve. The GA identified solutions that increased fitness by 0.7-45.5% over single contact activation by decreasing stimulation of non-targeted fascicles. Significance. This study suggests that using an optimal nerve cuff design and multiple contact activation could enable selective stimulation of the human PN trunk for

  15. Use of a Yankauer suction tip combined with the Colpo-Pneumo Occluder balloon to suction the surgical field at the vaginal cuff during robotic hysterectomy.

    PubMed

    Stitely, Michael L; Hashmi, Mahreen; Jain, Preiya; Hochberg, Charles

    2011-01-01

    A 39-year-old patient with complex endometrial hyperplasia without atypia underwent robotic total laparoscopic hysterectomy with bilateral salpingo-oophorectomy. The procedure was technically challenging because of the patient's obesity (body mass index 50 kg/m(2)). Concomitant suction of pooled blood and retraction of bowel and omentum were necessary to close the vaginal cuff. An endoscopic retractor was used through the assistant's port, and a Yankauer suction tip was placed through an inflated Colpo-Pneumo Occluder balloon in the vagina to provide directed suction to the vagina cuff. This technique enabled efficient closure of the vaginal cuff.

  16. Effects of cuff inflation and deflation on pulse transit time measured from ECG and multi-wavelength PPG.

    PubMed

    Liu, Jing; Li, Yao; Ding, Xiao-Rong; Dai, Wen-Xuan; Zhang, Yuan-Ting

    2015-01-01

    Pulse transit time (PTT), which refers to the time it takes a pulse wave to travel between two arterial sites is a promising index for cuff-less blood pressure (BP) estimation, as well as non-invasive assessment of arterial functions. However, it has not been investigated whether PTTs measured from ECG and different wavelength PPG are equally affected by the arterial status. Furthermore, comparison between the changes of different PTTs can provide enlightenment on the hardware implementation of the PTT-based BP estimation method. This work mainly studied the changes of PTTs calculated from electrocardiogram (ECG) and multi-wavelength photoplethysmogram (PPG) after exerting cuff pressure on the upper arm. A four-channel PPG acquisition system was developed to collect the multi-wavelength PPG signals of red, yellow, green and blue light at the fingertip simultaneously. Ten subjects participated in the experiment and their PTTs measured from different PPG and ECG signals before and after exerting cuff pressure were compared. This study found that within one minute after the four-minute cuff inflation and deflation process, the PTT measured from ECG and yellow PPG experienced a significant increase (p<;0.05) while the PTT from ECG and blue PPG had no statistical difference (p>0.9) compared with that before exerting cuff pressure. This indicates that PTTs calculated from different wavelength PPG have different recoverability from smooth muscle relaxation. Another interesting finding is that the PTT calculated from ECG and yellow PPG had a strong correlation (|r|>0.7) with the time difference between yellow PPG and other PPG signals, which implies the potential of the time difference between yellow PPG and other PPGs as a complementary to PTT-based model for blood pressure estimation. PMID:26737652

  17. Arteries Stiffen With Age, but Can Retain an Ability to Become More Elastic With Applied External Cuff Pressure.

    PubMed

    Liu, Chengyu; Zheng, Dingchang; Murray, Alan

    2015-10-01

    It is accepted that arterial compliance decreases with age, with changes in the arterial pulse shape measured at the periphery. The aim of this study was to determine the relationship between arterial transmural pressure changes and changes in peripheral finger pulse shape characteristics for both older and younger subjects.Finger photoplethysmographic pulses were recorded noninvasively from the right index fingers of 100 healthy normotensive subjects. Their median age was 43 years (range 20-71 years) allowing two distinct age groups to be compared (older group ≥45 and younger group < 45 years). Arterial transmural pressures on the whole right arm were reduced with a 50 cm long cuff inflated to 10, 20, 30, and 40 mmHg. Pulse maximum amplitude and rise time were calculated for each age group, and for each cuff pressure level.Gradual and significant decreases in both pulse maximum amplitude and rise time were found with increasing cuff pressure for both age groups. With an external cuff pressure of 40 mmHg, there was an average maximum amplitude and rise time decrease of 27.1% (P < 0.001) and 7.5% (P < 0.001) respectively. The changes in the older group were significantly greater than those in the younger group for maximum amplitude (30.3% vs 24.4%, P = 0.006), but not for rise time (8.0% vs 6.7%, P = 0.23).Our results show that arterial compliance of the arm artery increases with reduced transmural pressure for both older and younger groups, and demonstrate that the aged arm artery can become more elastic with applied external cuff pressure.

  18. Self management of oral anticoagulation: randomised trial

    PubMed Central

    Fitzmaurice, D A; Murray, E T; McCahon, D; Holder, R; Raftery, J P; Hussain, S; Sandhar, H; Hobbs, F D R

    2005-01-01

    Objective To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants. Design Multicentre open randomised controlled trial. Setting Midlands region of the UK. Participants 617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention. Intervention Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin. Main outcome measure Percentage of time spent within the therapeutic range of international normalised ratio. Results No significant differences were found in percentage of time in the therapeutic range between self managment and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm (χ2(df = 1) = 0.02, P = 0.89). Conclusion With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control. Trial registration ISRCTN 19313375. PMID:16216821

  19. Effect of Bone Mineral Density on Rotator Cuff Tear: An Osteoporotic Rabbit Model

    PubMed Central

    Chen, Xiaobin; Giambini, Hugo; Ben-Abraham, Ephraim; An, Kai-Nan; Nassr, Ahmad; Zhao, Chunfeng

    2015-01-01

    Introduction An increased bone mineral density (BMD) in the proximity to tendon insertion can improve rotator cuff repair and healing. However, how a decrease of BMD in the humeral head affects the biomechanical properties of the rotator cuff tendon is still unclear. Previous studies have demonstrated ovariectomy in animals to lead to osteoporosis and decreased BMD, and Teriparatide (PTH) administration to improve BMD and strength of bone. This study aimed to explore the correlation between humeral head BMD and infraspinatus (ISP) tendon insertion strength, and if an increase in bone quantity of the humeral head can improve the strength of the rotator cuff. Materials and Methods Eighteen New England white rabbits were divided into the 3 groups: Control, Ovariectomy-Saline (OVX-Saline), and Ovariectomy-PTH (OVX-PTH). The OVX-Saline group and the OVX-PTH were administered daily saline and Teriparatide injections for 8 weeks starting at 17 weeks of OVX. BMD of the humeral head was measured, the ISP tendon failure load was tested and the failure stress was calculated. One specimen from each group was used for histological analysis. Linear regression analysis was used to derive equations for the BMD and failure stress. Results Significant differences were observed in the measured humeral head BMD of the Control and OVX-PTH groups compared to the OVX-Saline group (P = 0.0004 and P = 0.0024, respectively). No significant difference was found in failure stress among the three groups, but an expected trend with the control group and OVX-PTH group presenting higher failure strength compared to the OVX-Saline group. BMD at the humeral head showed a positive linear correlation with stress (r2 = 0.54). Histology results showed the superiority in OVX-PTH group ISP enthesis compared to the OVX-Saline group. Conclusion Bone loss of the humeral head leads to decreased tendon/bone insertion strength of the infraspinatus tendon enthesis. Teriparatide administration can increase bone

  20. Reliability of Magnetic Resonance Imaging Assessment of Rotator Cuff: The ROW Study

    PubMed Central

    Jain, Nitin B.; Collins, Jamie; Newm