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JOINT SUPPORT: Can we perform a trial to test a caregiver intervention for people with chronic pain?

A feasibility study to assess the design of a multi-centre randomised controlled trial of the clinical and cost-effectiveness of a caregiving intervention for people with chronic musculoskeletal pain.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78169443
Enrollment
160
Registered
2022-04-11
Start date
2022-09-15
Completion date
Unknown
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of pain and associated symptoms for people with chronic musculoskeletal (bone, joint, muscle) Musculoskeletal Diseases

Interventions

Experimental Group: This consists of standard NHS care PLUS The JOINT SUPPORT programme which involves 5, 1- hour group sessions with a patient and their main caregiver. This will be run by a trained

Sponsors

University of East Anglia
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years and over with a history (6 weeks or more) of pain from a musculoskeletal (bone, joint or muscle) origin. 2. Patient currently has a secondary care referral or is attending physiotherapy, rheumatology, orthopaedic, occupational therapy or pain management services. 3. Patients able to nominate an individual who is an informal caregiver. An informal caregiver is defined as someone who has done or is expected to provide unpaid care, assistance, support or supervision in activities of daily living for at least three hours per week over two or more personal contacts. 4. Patients and caregivers willing and able to provide consent. 5. Patients and caregivers who can engage in a group-based intervention currently delivered in English. 6. If the participating hospital appointment is routinely an online or virtual appointment rather than an in-person face-to-face appointment, patient and caregiver participants must have access to a computer or tablet and internet services to receive a video consultation call.

Exclusion criteria

Exclusion criteria: 1. Patients or caregivers with acute (requiring hospitalisation) or terminal illness (life expectancy <6 weeks), which would make participation in the rehabilitation strategies contraindicated and/or impractical.

Design outcomes

Primary

MeasureTime frame
1. Ability to screen and identify potential participants (patients and caregivers) across the 5 sites measured using screening log data at baseline and 3 months follow-up 2. Willingness of eligible participants to consent and be randomised to intervention measured using semi-structured interviews at baseline and 3 months follow-up 3. Fidelity of healthcare professionals to deliver the experimental intervention and caregivers to adopt these post-group sessions measured using semi-structured telephone interviews at baseline and 3 months follow-up 4. Risk of intervention contamination measured using semi-structured interviews at baseline and 3 months follow-up

Secondary

MeasureTime frame
1. Patients will be assessed for the following at baseline and 3 months follow-up: 1.1. Health resource use using a study-specific health resource use questionnaire 1.2. Health-related quality of life using the 5-level EuroQol 5-Dimension (EQ-5D-5L) 1.3. Disease-specific function using the Musculoskeletal-Health Questionnaire (MSK-HQ) 1.4. Perceived self-efficacy using the General Self-Efficacy questionnaire 1.5. Depression symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D) 1.6. Pain using the Numerical rating scale (NRS) for pain 1.7. Fatigue using the Numerical rating scale (NRS) for fatigue 1.8. Complications and adverse events including a study-specific questionnaire 2. Caregivers will be assessed for the following at baseline and 3 months follow-up: 2.1. Health resource use using a study-specific health resource use questionnaire 2.2. Health-related quality of life using the 5-level EuroQol 5-Dimension (EQ-5D-5L) 2.3. Depression symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D) 2.4. Caregiver burden using the Short Sense of Competence Questionnaire (SSCQ) 2.5. Social and personal time quality of life using the Leisure Time Satisfaction questionnaire (LTS) 2.6. Complications and adverse events including a study-specific questionnaire

Countries

England, United Kingdom

Contacts

Public ContactToby Smith
toby.smith@uea.ac.uk+44 1603 593086

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 22, 2026