Clinical and cost effectiveness of progressive exercise compared to best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: a 2x2 factorial randomised controlled trial (The GRASP trial)

Record ID 32016001076
English
Authors' objectives: Shoulder pain is very common. Pain is caused by problems with the joints and muscles in the shoulder, called the rotator cuff. This is the most common type of shoulder pain, accounting for 70% of all new cases. The rotator cuff can be damaged through irritation and inflammation, trapping of the tendons and/or muscle tears. The main symptoms are pain and painful movement of the shoulder. It can substantially affect a person s ability to work, to sleep soundly and perform daily tasks. Common treatments include advice, rest, painkillers, anti-inflammatories, physiotherapy and steroid injections. Although used quite often, the effectiveness of physiotherapy is unclear. There is uncertainty about which techniques are most effective, how they should be delivered and whether an injection, in addition to exercise, may be of more benefit. The aim of our study is to test whether a progressive exercise programme supervised over a 16 week period compared with a single best practice advice session with a physiotherapist can improve outcomes for people with a rotator cuff problem. We will also test whether the addition of an injection of a corticosteroid into the shoulder joint helps to relieve pain, so enable comfortable exercise and improve function. To answer this question, we are recruiting men and women with a new episode of shoulder pain due to a rotator cuff problem and not currently receiving physiotherapy or being considered for surgery. We will recruit 704 people referred by their GP to 1 of 8 centres in the UK. People who consent will be randomised to 1 of 4 treatment groups: 1) progressive exercise (up to 6 sessions); 2) best practice advice (1 session); 3) progressive exercise and shoulder corticosteroid injection; or 4) best practice advice and shoulder corticosteroid injection. The exercise programme will include techniques to help people stick to the exercises given, as there is strong evidence that how a person thinks affects their compliance. We will ask people about their level of shoulder pain and ability to perform basic daily tasks over a one year period. We want to assess which of these routine interventions, or combination of interventions, are most clinically and cost effective for patients and the NHS. We have chosen to test exercise because it shows the greatest promise of all physiotherapy techniques; it is practical and relatively simple to deliver and has the strongest scientific basis. We will compare with best practice advice because several of our previous trials, in other areas, show that a typical course of NHS physiotherapy is no more effective than a single well-structured advice session that tackles people s anxieties about moving, reassures them and examines the shoulder to exclude serious underlying problems. Providing a single session is far more cost effective for the NHS. Injections will be given by physiotherapists, reflecting increasingly common practice across the NHS. The views of patients with rotator cuff disorders have been central to the development of our study. We have built on existing networks for patient involvement such as the Oxford Nuffield Orthopaedic Centre user groups for upper limb and physiotherapy, input obtained from the James Lind initiative (which brings together patients, carers and clinicians to address treatment uncertainties) for common shoulder problems, which members of our team are involved in, and through a formal Patient and Public Involvement development meeting.
Details
Project Status: Ongoing
Anticipated Publish Date: 2021
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England
MeSH Terms
  • Shoulder Injuries
  • Cost-Benefit Analysis
  • Exercise
  • Injections
  • Rotator Cuff
  • Shoulder Pain
  • Rotator Cuff Injuries
  • Shoulder Impingement Syndrome
  • Injections, Intra-Articular
  • Glucocorticoids
Contact
Organisation Name: NIHR Health Services and Delivery Research programme
Contact Address: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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