BMJ open · 2025
Pain management training for people with persistent pain and their informal carers (JOINT SUPPORT): multicentre randomised controlled feasibility trial with embedded qualitative study in English musculoskeletal services.
СтатьяМногоцентровое исследованиеPragmatic Clinical TrialРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Smith Toby, Khoury Reema, Welsh Allie, Crowther Coralie, Hanson Sarah, Grant Kelly, Clark Allan B, Ashford Polly-Anna, Hammond Matthew, Pond Martin, Dures Emma, Adams Jo
Аннотация
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, 1-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 (≤65 years). There was no blinding.
MAIN OUTCOME MEASURES: Data collected at baseline and 3 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: A total of 76 participants (38 patients; 38 carers) were enrolled. Sixty per cent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four per cent (13/24) of the experimental group reached minimal compliance with the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to 3 months favoured the control group when assessed by EQ-5D and Generalised Self-Efficacy total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scaletotal score. Qualitative data demonstrated the 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.
TRIAL REGISTRATION NUMBER: ISRCTN78169443.
DATA AVAILABILITY STATEMENT: The data that support the findings of this study are available from the corresponding author (TS) on reasonable request. This includes access to the full protocol, anonymised participant-level dataset and statistical code.
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, 1-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 (≤65 years). There was no blinding.
MAIN OUTCOME MEASURES: Data collected at baseline and 3 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: A total of 76 participants (38 patients; 38 carers) were enrolled. Sixty per cent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four per cent (13/24) of the experimental group reached minimal compliance with the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to 3 months favoured the control group when assessed by EQ-5D and Generalised Self-Efficacy total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scaletotal score. Qualitative data demonstrated the 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.
TRIAL REGISTRATION NUMBER: ISRCTN78169443.
DATA AVAILABILITY STATEMENT: The data that support the findings of this study are available from the corresponding author (TS) on reasonable request. This includes access to the full protocol, anonymised participant-level dataset and statistical code.