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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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date November 20, 2023
Est. primary completion date November 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: The inclusion criteria for the clinician participants are: - A qualified (HCPC registered) physiotherapist involved in the management of patients with a RC disorder at one of the trial sites; - Willing to consent to the study procedures, including attending a training workshop, audio-recording of the consultations and audit/feedback on intervention delivery. The inclusion criteria for patient participants are: - Adult (aged 18 or over); - Diagnosed with a RC disorder as per the diagnostic criteria in the British Elbow and Shoulder Society guidelines (Kulkarni et al., 2015), which includes pain mid-range on abduction movement, pain on resisted tests and no loss of external rotation, along with screening of the neck and ruling out other conditions (e.g., instability/frozen shoulder). This will be confirmed by the site Principal Investigators (PI), specialist HCPC registered physiotherapists; - Able to attend at least one face-to-face physiotherapy consultation. Eligibility will be confirmed via physical examination at this session as per the criteria above; - Able to give full informed consent; - Willing to consent to the study procedures, including audio-recording of the consultations. Exclusion Criteria: The exclusion criteria for the patient participants are: - Significant trauma; - Neurological or inflammatory causes of their shoulder pain; - Any clinical indications of serious pathology. We will not exclude anyone based upon protected characteristics for example, age and ethnicity. Anyone referred into the physiotherapy department with a RC disorder will be eligible to take part in the study. Measures in place may include support for the consent process, consultation or patient interviews where required, for example, if verbal translation is needed via a hospital interpreter, personal interpreter or telephone translation service.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The COMBINED approach
Patient-level intervention: Assessment of existing lifestyle factors (smoking status, physical activity levels, and weight) that may be relevant to shoulder pain; Brief intervention to support health behaviour change: smoking cessation, increasing physical activity levels and consuming a healthy diet Supporting tools for behaviour change, including an activity workbook for goal-setting and a diary for self-monitoring. Clinician-level implementation toolkit: Training package including a face-to-face workshop, training manual, recorded role play simulations and an online follow-up training session Additional supporting resources; a step-by-step guide to The COMBINED approach, scripts, patient signposting information to support services and a lay summary infographic to explain the links between the health behaviours and RC disorders to patients Audit and feedback via observations of consultations to address any 'drift' from the intervention delivery as intended

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Julie Bury Manchester Metropolitan University

Outcome

Type Measure Description Time frame Safety issue
Primary To assess a change in the Determinants of Behavior Questionnaire (DIBQ) Physiotherapy self-report survey At baseline (0 months) and study completion (expected at 6 months)
Primary Fidelity of intervention delivery (self-report checklist by the physiotherapists) will be reported descriptively What intervention components were delivered by the physiotherapists as intended 6 months
Primary Fidelity of intervention delivery (observed through audio-recordings by the research team) will be reported descriptively What intervention components were delivered by the physiotherapists as intended 6 months
Secondary Number of patients recruited that have one or more of the identified lifestyle factor will be reported descriptively Identified lifestyle factors include: Smoker; BMI >25kg/m2; physical activity levels <150/minutes of moderate intensity/week 6 months
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