Jane Moser

Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial]

BACKGROUND Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff. OBJECTIVE To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged ≥ 50 years with degenerative rotator cuff tendon tears. DESIGN Two parallel-group randomised controlled trial. SETTING Nineteen teaching and district general hospitals in the UK. PARTICIPANTS Patients (n = 273) aged ≥ 50 years with degenerative rotator cuff tendon tears. INTERVENTIONS Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation. MAIN OUTCOME MEASURES The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair. RESULTS The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was -0.76 [95% confidence interval (CI) -2.75 to 1.22; p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score -0.46, 95% CI -5.30 to 4.39; p = 0.854). The questionnaire response rate was > 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component resource-use categories, nor for the total follow-up costs at 24 months. The overall treatment cost at 2 years was £2567 (SD £176) for arthroscopic surgery and £2699 (SD £149) for open surgery, according to intention-to-treat analysis. For the per-protocol analysis there was a significant difference in total initial procedure-related costs between the arthroscopic group and the open repair group, with arthroscopic repair being more costly by £371 (95% CI £135 to £607). Total quality-adjusted life-years accrued at 24 months averaged 1.34 (SD 0.05) in the arthroscopic repair group and 1.35 (SD 0.05) in the open repair group, a non-significant difference of 0.01 (95% CI -0.11 to 0.10). The rate of re-tear was not significantly different across the randomised groups (46.4% and 38.6% for arthroscopic and open surgery, respectively). The participants with tears that were impossible to repair had the lowest OSSs, the participants with re-tears had slightly higher OSSs and the participants with healed repairs had the most improved OSSs. These findings were the same when analysed per protocol. CONCLUSION In patients aged > 50 years with a degenerative rotator cuff tear there is no difference in clinical effectiveness or cost-effectiveness between open repair and arthroscopic repair at 2 years for the primary outcome (OSS) and all other prespecified secondary outcomes. Future work should explore new methods to improve tendon healing and reduce the high rate of re-tears observed in this trial. TRIAL REGISTRATION Current Controlled Trials ISRCTN97804283. FUNDING This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 80. See the NIHR Journals Library website for further project information.

Surgical options for patients with shoulder pain

Shoulder pain is a common musculoskeletal complaint in the community, which can arise from diverse causes. Regardless of the cause, mild cases can often be effectively treated conservatively, with options including rest, physiotherapy, pain relief and glucocorticoid injections. If conservative strategies fail after a 3–6 month period then surgery might be considered. Generally, the proportion of patients with shoulder pain who require surgery is small. When surgery is considered, a clear diagnosis and structural information from imaging are required. The indications for surgery, and success rate, depend on the specific diagnosis as well as on the individual clinical presentation. Evidence from case series suggest that surgical interventions for shoulder pain are effective when used appropriately. This article outlines the surgical management of the most common painful conditions that affect the shoulder, including impingement, rotator cuff tear, frozen shoulder, osteoarthritis, rheumatoid arthritis and calcific tendonitis.

Consensus for physiotherapy for shoulder pain

PurposeShoulder pain is a common disorder. Despite growing evidence of the importance of physiotherapy, in particular active exercise therapy, little data is available to guide treatment. The aim of this project was to contribute to the development of an internationally accepted assessment and treatment algorithm for patients with shoulder pain.MethodsNine physiotherapists with expertise in the treatment of shoulder dysfunction met in Sweden 2012 to begin the process of developing a treatment algorithm. A questionnaire was completed prior to the meeting to guide discussions. Virtual conferences were thereafter the platform to reach consensus.ResultsConsensus was achieved on a clinical reasoning algorithm to guide the assessment and treatment for patients presenting with local shoulder pain, without significant passive range of motion deficits and no symptoms or signs of instability. The algorithm emphasises that physiotherapy treatment decisions should be based on physical assessment findings and not structural pathology, that active exercises should be the primary treatment approach, and that regular re-assessment is performed to ensure that all clinical features contributing to the presenting shoulder pain are addressed. Consensus was also achieved on a set of guiding principles for implementing exercise therapy for shoulder pain, namely, a limited number of exercises, performed with appropriate scapulo-humeral coordination and humeral head alignment, in a graduated manner without provoking the presenting shoulder pain.ConclusionThe assessment and treatment algorithm presented could contribute to a more formal, extensive process aimed at achieving international agreement on an algorithm to guide physiotherapy treatment for shoulder pain.

Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): A multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial

Summary Background Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression. Methods We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011. Findings Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference −1·3 points (95% CI −3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5–5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8–6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group). Interpretation Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process. Funding Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).

The CSAW Study (Can Shoulder Arthroscopy Work?) – a placebo-controlled surgical intervention trial assessing the clinical and cost effectiveness of arthroscopic subacromial decompression for shoulder pain: study protocol for a randomised controlled trial

BackgroundArthroscopic subacromial decompression (ASAD) is a commonly performed surgical intervention for shoulder pain. The rationale is that removal of a bony acromial spur relieves symptoms by decompressing rotator cuff tendons passing through the subacromial space. However, the efficacy of this procedure is uncertain. The objective of this trial was to compare the efficacy and cost-effectiveness of ASAD in patients with subacromial pain using appropriate control groups, including placebo intervention.Methods/DesignThe trial is a three-group, parallel design, pragmatic, randomised controlled study. The intervention content for each group (ASAD, active monitoring with specialist reassessment (AMSR) and investigational shoulder arthroscopy only (AO)) enables assessment of (1) the efficacy of the surgery against no surgery; (2) the need for a specific component of the surgery—namely, removal of the bony spur; and (3) quantification of the placebo effect. Concealed allocation was performed using a 1:1:1 randomisation ratio and using age, sex, baseline Oxford Shoulder Score (OSS) and centre as minimisation criteria. The primary outcome measure is the OSS at 6 months post randomisation. A total of 300 patients recruited over 24 months from a minimum of 14 UK shoulder units over 24 months were required to detect a difference of 4.5 points on the OSS (standard deviation, 9) with 90% power and to allow for 15% loss to follow-up. Secondary outcomes include cost-effectiveness, pain, complications and patient satisfaction. A substantial qualitative research component is included. The primary analysis will be conducted on the modified intention-to-treat analysis. Sensitivity analysis will be used to assess the robustness of the results with regard to the underlying assumptions about missing data using multiple imputation.DiscussionThis trial uses an innovative design to account for the known placebo effects of surgery, but it also will delineate the mechanism for any benefit from surgery. The investigational AO group is considered a placebo intervention (not sham surgery), as it includes all components of subacromial decompression except the critical surgical element. Some discussion is also dedicated to the challenges of conducting placebo surgery trials.Trial registrationsUK Clinical Research Network UKCRN12104. Registered 22 May 2012.International Standard Randomised Controlled Trial ISRCTN33864128. Registered 22 June 2012.ClinicalTrials.gov NCT01623011. Registered 15 June 2012.

Protocol for the United Kingdom Rotator Cuff Study (UKUFF): a randomised controlled trial of open and arthroscopic rotator cuff repair

This protocol describes a pragmatic multicentre randomised controlled trial (RCT) to assess the clinical and cost effectiveness of arthroscopic and open surgery in the management of rotator cuff tears. This trial began in 2007 and was modified in 2010, with the removal of a non-operative arm due to high rates of early crossover to surgery. Cite this article: Bone Joint Res 2014;3:155–60.

Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomised controlled trial

AIMS The appropriate management for patients with a degenerative tear of the rotator cuff remains controversial, but operative treatment, particularly arthroscopic surgery, is increasingly being used. Our aim in this paper was to compare the effectiveness of arthroscopic with open repair of the rotator cuff. PATIENTS AND METHODS A total of 273 patients were recruited to a randomised comparison trial (136 to arthroscopic surgery and 137 to open surgery) from 19 teaching and general hospitals in the United Kingdom. The surgeons used their usual preferred method of repair. The Oxford Shoulder Score (OSS), two years post-operatively, was the primary outcome measure. Imaging of the shoulder was performed at one year after surgery. The trial is registered with Current Controlled Trials, ISRCTN97804283. RESULTS The mean OSS improved from 26.3 (standard deviation (sd) 8.2) at baseline, to 41.7 (sd 7.9) two years post-operatively for arthroscopic surgery and from 25.0 (sd 8.0) to 41.5 (sd 7.9) for open surgery. Intention-to-treat (ITT) analysis showed no statistical difference between the groups at two years (difference in OSS score -0.76; 95% confidence interval (CI) -2.75 to 1.22; p = 0.452). The confidence interval excluded the pre-determined clinically important difference in the OSS of three points. The rate of re-tear was not significantly different between the two groups (46.4% for arthroscopic and 38.6% for open surgery; 95% CI -6.9 to 25.8; p = 0.256). Healed repairs had the most improved OSS. These findings were the same when analysed per-protocol. CONCLUSION There is no evidence of difference in effectiveness between open and arthroscopic repair of rotator cuff tears. The rate of re-tear is high in both groups, for all sizes of tear and ages and this adversely affects the outcome. Cite this article: Bone Joint J 2017;99-B:107-15.

Living with a symptomatic rotator cuff tear 'bad days, bad nights': a qualitative study.

BackgroundRotator cuff tears are a common cause of shoulder pain. There is an absence of information about symptomatic rotator cuffs from the patients’ perspective; this limits the information clinicians can share with patients and the information that patients can access via sources such as the internet. This study describes the experiences of people with a symptomatic rotator cuff, their symptoms, the impact upon their daily lives and the coping strategies utilised by study participants.MethodsAn interpretive phenomenological analysis approach was used. 20 participants of the UKUFF trial (The United Kingdom Rotator Cuff Surgery Trial) agreed to participate in in-depth semi-structured interviews about their experiences about living with a symptomatic rotator cuff tear. Interviews were digitally recorded and fully transcribed. Field notes, memos and a reflexive diary were used. Data was coded in accordance with interpretive phenomenological analysis. Peer review, code-recode audits and constant comparison of data, codes and categories occurred throughout.ResultsThe majority of patients described intense pain and severely disturbed sleep. Limited movement and reduced muscle strength were described by some participants. The predominantly adverse impact that a symptomatic rotator cuff tear had upon activities of daily living, leisure activities and occupation was described. The emotional and financial impact and impact upon caring roles were detailed. Coping strategies included attempting to carry on as normally as possible, accepting their condition, using their other arm, using analgesics, aids and adaptions.ConclusionsClinicians need to appreciate and understand the intensity and shocking nature of pain that may be experienced by participants with known rotator cuff tears and understand the detrimental impact tears can have upon all areas of patient’s lives. Clinicians also need to be aware of the potential emotional impact caused by cuff tears and to ensure that patients needing help for conditions such as depression are speedily identified and provided with support, explanation and appropriate treatment.

Physiotherapy assessment of patients with rotator cuff pathology

Pathology of the rotator cuff and sub-acromial bursa are considered to be the main cause of shoulder pain and dysfunction. In the absence of trauma, conservative care, including physiotherapy is the primary treatment. This paper aims to present the key features of a physiotherapy assessment, excluding diagnostic tests for rotator cuff pathology. It describes and explores how assessment can be used to direct management options and develop a treatment plan.

Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER)

BackgroundMusculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER).MethodsA pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres.DiscussionThe PROSPER intervention incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity; and behavioural strategies to encourage adherence and support exercise behaviour. The final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN 35358984.