Smith, Toby O., Khoury, Reema, Welsh, Allie, Crowther, Coralie, Hanson, Sarah, Grant, Kelly, Clark, Allan B., Ashford, Polly-Anna, Hammond, Matthew, Pond, Martin, Dures, Emma and Adams, Jo (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. BMJ Open, 15 (4). ISSN 2044-6055
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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.
Item Type: | Article |
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Additional Information: | Data availability statement: Data are available upon reasonable request. Data are available upon reasonable request. Data include access to the full protocol, anonymised participant level dataset and statistical code. Access to the de-identified dataset for purposes of research other than this study would be at the discretion of the Chief Investigator, TOS and Norwich CTU. Requests for the de-identified dataset generated during the current study should be made to the Chief Investigator, TOS (email: toby.o.smith@warwick. ac.uk) or Norwich CTU (NorwichCTU@uea.ac.uk). TOS and Norwich CTU will consider requests once the main results from the study have been published up until 31 December 2028. Funding Information: This study is funded by the National Institute for Health Research (NIHR) Research for Patient Benefit grant (NIHR202723). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. |
Uncontrolled Keywords: | pain,chronic,self-management,carer,caregiver,feasibility rct,caregivers,qualitative research,pain management,randomised controlled trial,rehabilitation medicine,medicine(all) ,/dk/atira/pure/subjectarea/asjc/2700 |
Faculty \ School: | Faculty of Medicine and Health Sciences > School of Health Sciences Faculty of Medicine and Health Sciences > Norwich Medical School |
UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Centres > Population Health Faculty of Science > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre Faculty of Medicine and Health Sciences > Research Groups > Health Promotion Faculty of Medicine and Health Sciences > Research Groups > Nutrition and Preventive Medicine Faculty of Medicine and Health Sciences > Research Centres > Norwich Institute for Healthy Aging Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care Faculty of Science > Research Groups > Statistics |
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Depositing User: | LivePure Connector |
Date Deposited: | 17 Feb 2025 10:30 |
Last Modified: | 14 Jul 2025 09:33 |
URI: | https://ueaeprints.uea.ac.uk/id/eprint/98510 |
DOI: | 10.1136/bmjopen-2024-095069 |
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