Abstract
Objectives: To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a pain management training intervention to support people with persistent musculoskeletal pain and their informal carers.
Design: Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.
Setting: National Health Service (NHS) providers in four English hospitals.
Participants: Adults receiving NHS care for persistent musculoskeletal pain and their informal carers.
Intervention: Control: usual NHS care. Experimental: usual NHS care plus a carer–patient pain management training intervention (JOINT SUPPORT), comprising five, one-hour, group-based sessions for patients and carers, delivered by trained physiotherapists or occupational therapists. Content included: understanding pain, pacing, graded activity, fear avoidance, goal-setting, understanding the benefits of physical activity and medication management. This was re-enforced with a workbook. After the group-based sessions, patients and carers were supported through three telephone sessions.
Randomisation: Central randomisation was computer generated (2:1 Experimental: Control), stratified by hospital and patient-participant age (< and equal to 65 years). There was no blinding.
Main outcome measures: Data collected at baseline and three months post-randomisation included: screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Interviews with 14 patient-carer participants and six health professionals who delivered the intervention.
Results: 76 participants (38 patients; 38 carers) were enrolled. Sixty percent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four percent (13/24) of the experimental group reached minimal compliance to the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to three months favoured the control group when assessed by EQ-5D and GSE total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scale (CES-D) total score. Qualitative data demonstrated acceptability of the trial design and JOINT SUPPORT intervention with modifications to improve trial processes.
Conclusions: The JOINT SUPPORT intervention was acceptable to patient–carer dyads and health professionals. Modifications to trial design, particularly enhanced recruitment strategies, are required.
Design: Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.
Setting: National Health Service (NHS) providers in four English hospitals.
Participants: Adults receiving NHS care for persistent musculoskeletal pain and their informal carers.
Intervention: Control: usual NHS care. Experimental: usual NHS care plus a carer–patient pain management training intervention (JOINT SUPPORT), comprising five, one-hour, group-based sessions for patients and carers, delivered by trained physiotherapists or occupational therapists. Content included: understanding pain, pacing, graded activity, fear avoidance, goal-setting, understanding the benefits of physical activity and medication management. This was re-enforced with a workbook. After the group-based sessions, patients and carers were supported through three telephone sessions.
Randomisation: Central randomisation was computer generated (2:1 Experimental: Control), stratified by hospital and patient-participant age (< and equal to 65 years). There was no blinding.
Main outcome measures: Data collected at baseline and three months post-randomisation included: screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Interviews with 14 patient-carer participants and six health professionals who delivered the intervention.
Results: 76 participants (38 patients; 38 carers) were enrolled. Sixty percent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four percent (13/24) of the experimental group reached minimal compliance to the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to three months favoured the control group when assessed by EQ-5D and GSE total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scale (CES-D) total score. Qualitative data demonstrated acceptability of the trial design and JOINT SUPPORT intervention with modifications to improve trial processes.
Conclusions: The JOINT SUPPORT intervention was acceptable to patient–carer dyads and health professionals. Modifications to trial design, particularly enhanced recruitment strategies, are required.
| Original language | English |
|---|---|
| Journal | BMJ Open |
| Publication status | Accepted/In press - 14 Feb 2025 |
Keywords
- pain
- chronic
- self-management
- carer
- caregiver
- feasibility RCT