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

Abstract

BackgroundShoulder 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/DesignA 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 Services perspective to evaluate cost-effectiveness and a qualitative investigation will be undertaken to develop greater understanding of the experience of undertaking or prescribing exercise as a self-managed therapy.Trial registration numberISRCTN84709751

A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study)

“…The protocol was approved by the National Research Ethics Service Committee Yorkshire & the Humber (Ref 11/YH/0443) and published online (6).…”

Referring doctors' perspectives about Physiotherapy management for chronic musculoskeletal pain

“…Once treated by an orthopedic rehabilitation specialist (including physiotherapist), high levels of patient satisfaction (99.5%) and better outcomes were achieved [3]. Physiotherapy has proved to produce persistent benefits in many chronic and disabling conditions like knee pain [4], low back pain [5], neck pain [6] and shoulder pain [7]. Jessep et al in 2009 [4] conducted a study on 64 patients diagnosed with chronic knee pain attending the outpatient Physiotherapy department in UK.…”

“…This trial threw light on the positive benefits that Physiotherapy treatment may have for chronic neck pain. The study by Littlewood et al in 2012 [7] looked into the benefits of Physiotherapy over self-managed exercises for patients suffering from disabling shoulder pain. In another study by Pinnington et al in 2004 [11], it was found that early intervention by a physiotherapist is feasible and acceptable to the patients.…”

“…Despite the smaller sample size in this pilot study, it was evident that doctor's referral to Physiotherapy treatment could have affected the perception of the patients towards exercise therapy (as a possible solution to their chronic musculoskeletal joint aches and pains). While there are many studies that have looked at the benefits of using exercises and manual therapy techniques for Physiotherapy management of chronic pain [4][5][6][7], there is not much research to justify the use of electrotherapeutic modalities for treatment of chronic pain. Hence, it can be said that the awareness about the different treatment strategies used by a physiotherapist is not well known by the other specialists who are a part of the rehabilitation team.…”

Is tendinopathy research at a crossroads?

“…One barrier to performing tendon-loading studies is the belief that tendon rehabilitation is not a ‘one size fits all’ and is not conducive to single intervention RCTs preferred by academics or clinical journals. However, a study using a pragmatic approach and general principles has been implemented for rotator cuff tendon pathology,9 so there is no reason why we cannot extrapolate this approach to other tendinopathies. …”