The COMBINED study
Research type
Research Study
Full title
COmbining brief interventions for Modifiable health Behaviours withIN a physiotherapy consultation for pEople with a rotator cuff Disorder: development and testing in a single-arm feasibility study (COMBINED)
IRAS ID
322325
Contact name
Julie Bury
Contact email
Sponsor organisation
Manchester Metropolitan University
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 29 days
Research summary
The COMBINED study is looking at how we can improve current treatments for people with shoulder pain, who have been diagnosed with a rotator cuff (RC) disorder. The RC is a group of muscles and tendons which move and stabilise the shoulder joint, and problems with these muscles and tendons can result in pain and difficulty doing everyday tasks.
Current treatments for RC disorders offer only small to moderate benefits and long-term outcomes can be poor. Lifestyle factors, including smoking, being overweight and physical inactivity are associated with the onset and persistence of RC disorders. These factors are linked to modifiable health behaviours that if patients are supported to change, might help improve their shoulder pain. Despite this evidence, physiotherapists do not routinely integrate health behaviour change approaches as part of the management for RC disorders.We have designed and tested a new physiotherapy-supported treatment approach, The COMBINED approach, that combines the assessment and management of the lifestyle factors together with current treatments, such as exercises for strengthening the muscles and tendons of the shoulder. We would like to find out if this treatment approach can be delivered within the NHS and to improve this further before testing it in a larger study. The overall aim is to provide better care for people with a RC disorder.
This will be a non-randomised feasibility study with qualitative interviews. The study will be conducted in physiotherapy musculoskeletal services across four NHS sites and expected to last 4-6 months. Chartered physiotherapists working at one of the musculoskeletal physiotherapy services, and patients diagnosed with a RC disorder will be eligible to take part.
This research is funded by the National Institute for Health & Care Research (NIHR) Clinical Doctoral Research Fellowship Programme (Ref: NIHR300541).
Physiotherapist participants would be expected to attend a training workshop, deliver the new treatment approach to patients and complete a survey. Patient participants would be asked to attend up to two treatment sessions for their shoulder pain (~60 mins each) with a qualified physiotherapist. During this treatment session they will be asked some questions about their shoulder pain and other things that could be influencing their shoulder pain, such as if they smoke, their weight and how active they are. Where applicable, the physiotherapist may also measure their height and weight during the consultation. They will have an examination of their shoulder. Different treatment options will then be discussed. This will be very similar to what you would expect in a normal physiotherapy appointment. The treatment sessions will be audio-recorded (with consent), for the purpose of checking what information and treatment was delivered by the physiotherapist in the session. The lead researcher may also request (with consent), to observe one of the treatment sessions. The purpose of this is to identify ways to improve how physiotherapists deliver the new treatment approach.
A selection of patients will be asked to take part in an optional short (up to 20 minutes) telephone interview about their views and experience of the treatment session.REC name
West of Scotland REC 4
REC reference
23/WS/0073
Date of REC Opinion
7 Jun 2023
REC opinion
Further Information Favourable Opinion