Title: The effectiveness of a treatment for posterior shoulder tightness in combination with ‘best care’ compared with 'best care' alone in individuals with shoulder impingement syndrome: a randomised controlled trial.
Funder: Health Education England

Abstract: Introduction Shoulder impingement syndrome is the most common musculoskeletal shoulder condition and causes significant pain and disability. Physiotherapy is the recommended initial intervention for this condition, however if treatment is unsuccessful patients are often referred to an orthopaedic consultant for an opinion regarding the suitability of surgical intervention. Randomised controlled trials and systematic reviews have demonstrated that at one and four year follow-up the outcomes are very similar for physiotherapy and surgical intervention. Despite this, surgery for shoulder impingement is on the rise.The most effective form of physiotherapy (best care) for this condition involves strengthening and stretching exercises for the scapular and rotator cuff muscles, and education. Many authors recommend the treatment of posterior shoulder tightness in the management of shoulder impingement syndrome, but there is a lack of good quality evidence to support this perspective. The goal of this study is to determine whether the treatment of posterior shoulder tightness can convey additional benefits when added to existing best care. Research question To what extent does an intervention to address posterior shoulder tightness, in combination with best care', improve function and reduce the need for surgery in subjects with a clinical diagnosis of shoulder impingement when compared with best care' alone: a randomised controlled clinical trial. Trial design The study will be a randomised, controlled, double blind (patient and assessor), parallel group trial with a 1:1 allocation ratio. The patients will be assessed for inclusion/exclusion criteria and then randomly allocated into one of two groups. Both groups will receive best care' physiotherapy. The treatment group will also receive specific intervention for posterior shoulder tightness; the placebo group will receive placebo posterior shoulder tightness intervention as well as best care'. The primary outcome measure is the Shoulder Pain and Disability Index (SPADI). Secondary outcomes include: the EQ-5D-5L quality of life questionnaire, the need for surgery following physiotherapy and the health economic evaluation of the two treatment arms.Study Setting Patients will be recruited from the surgical waiting list at Western Sussex Hospitals NHS Trust and treatment will take place in the physiotherapy department in a secondary care setting. Sample size and data collection Sample size calculations, with threshold of significance and power set at 5% and 90% respectively, demonstrated that 23 participants are required in each group (study size = 46) in order to detect an effect size of 0.4 (SD = 20, constant correlation over time = 0.6). Recruitment will be increased to 56 to account for a 15% dropout rate. A conservative estimate of recruitment rate based on analysis of current waiting lists is 2.4 patients per month. It has been estimated that recruitment targets will be reached within 24 months. Data collection will take place prior to random allocation, half way through the intervention (6-8 weeks) and at the end of the intervention (13-15 weeks). At 52 weeks a follow-up telephone interview will include completion of the SPADI questionnaire and evaluate the surgical outcome.Physiotherapy treatment Treatment will be delivered over 13 weeks and will consist of 8 sessions of physiotherapy. The first 4 sessions will be delivered weekly and the subsequent 4 sessions will be delivered every 2 weeks. The treatment will be delivered by NHS physiotherapists as part of their normal caseload. Potential benefit Physiotherapy offers a non-invasive approach with negligible risks for the management of shoulder impingement syndrome. The goal of this research is to identify whether treating posterior shoulder tightness in combination with 'best care' will have significant benefits for patients, in terms of reduced pain and disability, and for commissioners in terms of reduced cost for the management of this condition.

Lay abstract: Shoulder impingement syndrome is very common and normally treated with physiotherapy or surgery. Research has shown that physiotherapy is as effective as surgery, however, the most effective form of physiotherapy is not known. Posterior shoulder tightness is thought to be a major cause of shoulder pain. Patients awaiting surgery will be assigned to receive best care' physiotherapy, with or without treatment for posterior shoulder tightness. The results will help us to understand if this is an important part of physiotherapy treatment, which might help reduce patient's pain and disability as well as reduce the cost of treatment for the NHS.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL