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
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.Summary of results
Summary of Results This feasibility study has evaluated the implementation of The COMBINED approach prototype (V2.0) to facilitate ongoing intervention refinements. The study ran for four months between the 3rd July-25th October 2023. Overall, 17 patients and 8 physiotherapists were recruited from four NHS sites. Two physiotherapists were lost to follow-up (survey data) as they did not deliver the intervention in their role as Principal Investigator. Eight patients completed an interview.
Patient Characteristics: 53% of participants were female with a mean age of 59 years (39-74 years). In terms of ethnicity, 82% of participants were White British, 12 % Asian British Indian and 1% White Irish. 71% of participants had an identified lifestyle factor, with 58% of these reporting more than one relevant lifestyle factor.
Clinician characteristics: 50% of participants were female with a mean number of years qualified of 17 years (6-34 years). In terms of ethnicity, 50% of participants were White British, 13% Asian British Pakistani, 13% White other, 13% White and Asian, and 13% Multiple ethnicity.
Fidelity Assessment:
All consultations were recorded. Three recordings were lost due to user error, but these consultations were observed enabling the fidelity checklist to be completed directly from the observation. For the initial consultation, the fidelity assessment showed that overall, 82% of the aspects of the intervention were delivered as intended in line with the training. For the follow-up consultations, overall, 80% of the aspects of the intervention were delivered as intended in line with the training.
Survey data:
An assessment of the key domains of behaviour change influencing the implementation of The COMBINED approach among physiotherapists identified several domains as key barriers. Five of the 10 Theoretical Domains Framework (TDF) domains were identified as potential barriers (median domain score <6) influencing implementation behaviours at baseline (post training), including: beliefs about capabilities (median score 4); goals (median score 4.5); behavioural regulation (median score 4.5); environmental context and resources (median score 5); and emotion (median score 4.6). Five of the 10 TDF domains were identified as potential facilitators (median domain score ≥6) at baseline, including: knowledge (median score 7), skills (median score 6), professional role and identity (median score 6), optimism (median score 6), and beliefs about consequences (median score 6). Four of the ten TDF domains increased in median score post intervention delivery (beliefs about capabilities; behavioural regulation; environmental context and resources; and emotion). The domains environmental context and resources, and emotions increased to a score of 6, therefore no longer considered a potential barrier. Changes in scores for the TDF domains post intervention delivery were not reflected in the higher scoring domains (≥6).
Evaluation of the feasibility of recruitment (the number of patients who consented to the study and had an identified lifestyle factor) showed that 71% of participants recruited had a lifestyle factor. Overall, recruitment was positive with patients willing to be recruited, and 17 participants were recruited in a 4-month period. Study recruitment was stopped after four months based on the pre-determined criteria that recruiting 12-15 participants over a 4-6 recruitment period would provide sufficient data to achieve the study objectives.
Exploring the patient experience of receiving The COMBINED approach found that lifestyle discussions and an assessment of lifestyle factors were expected and acceptable to patients, and in some cases improved their experience and expectations of the physiotherapy consultation. Furthermore, patients had initiated lifestyle behaviour change after the consultation. Despite patients reporting they understood the role of lifestyle factors in the management of their shoulder condition, there was poor information recall about the underpinning systemic inflammatory mechanisms. Further work is needed to understand how to aid patient recall, which might be an important strategy to patients initiating and maintaining health behaviour change. Most patients also reported not using the resource pack post consultation, which included resources for supporting long term behaviour change such as action planning and self-monitoring. Future considerations need to include how we encourage increased engagement with the resources, such as electronic versions, and encouraging patients to complete these for review with the physiotherapist.
Overall, this study has demonstrated the feasibility of a future definitive trial including successful patient recruitment and intervention fidelity of The COMBINED approach prototype (V2.0), along with patient acceptability. Patients found The COMBINED approach acceptable and reported initiating health behaviour changes in their RC management. Factors influencing implementation, such as beliefs about capabilities (i.e., confidence), goals (i.e., relative importance), and behavioural regulation (i.e., automaticity), were identified and will guide refinements to the implementation toolkit in readiness for a future, large, randomised controlled trial.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