The COMBINED Study to Integrate Health Behaviour Change for People With a Rotator Cuff Disorder

Physiotherapy Clinical Trial

— COMBINED  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05829096
• Other study ID #: 51451
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Physiotherapy
• Rotator Cuff Impingement Syndrome
• Rotator Cuff Syndrome
• Shoulder Impingement Syndrome
• Syndrome

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