Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05829096 |
Other study ID # |
51451 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2023 |
Est. completion date |
November 20, 2023 |
Study information
Verified date |
April 2023 |
Source |
Manchester Metropolitan University |
Contact |
Julie Bury |
Phone |
+441302 644069 |
Email |
julie.bury[@]stu.mmu.ac.uk |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
COMBINED is a pragmatic single-arm feasibility study. The goal of this study is to evaluate
the implementation of a physiotherapy-led intervention, The COMBINED approach, to facilitate
ongoing refinements, including the strategies for implementation, in readiness for a
definitive trial in people with a rotator cuff disorder. The main questions it aims to answer
are: 1) What are the key domains of behaviour change influencing the implementation of The
COMBINED approach among physiotherapists? 2) Can The COMBINED approach be delivered as
intended? 3) Are there any refinements required to the intervention components? 4) What is
the patient experience of receiving The COMBINED approach in an NHS setting?
Description:
The COMBINED study is looking at how current treatments can be improved 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.
The investigators have designed and tested a new complex intervention, The COMBINED approach,
that aims to help patients improve their shoulder pain by identifying and assessing the
lifestyle factors associated with the onset and persistence of a RC disorder and, where
appropriate, the delivery of a brief behaviour change intervention to address these as part
of a management plan, supported by a physiotherapist. The investigators have also developed
an implementation toolkit to enable and support physiotherapists to effectively deliver this
approach in clinical practice. This has been tested and refined in a small usability study,
which has led to an optimised version of The COMBINED approach. The investigators would like
to find out if this treatment approach can now be delivered within the NHS and to improve
this further before testing it in a definitive randomised controlled trial. 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.
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. The participants will have an
examination of their shoulder. Different treatment options will then be discussed. This will
be very similar to what participants 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.