Clinical and Cost-Effectiveness of an Online-Delivered Group-Based Pain Management Programme in Improving Pain-Related Disability for People with Persistent Pain - A Non-Inferiority Randomised Controlled Trial (iSelf-Help Trial)
Authors List
Devan, H., Rehabilitation Teaching and Research Unit (RTRU), Department of Medicine, University of Otago, Wellington, NZ
Perry, M.A., Centre for Health, Activity, and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago, Wellington, NZ
Davies, C., Tū Kotahi Māori Asthma and Research Trust, Wellington, NZ
Dean, S., University of Exeter, Exeter, United Kingdom
Dowell, A., Department of Primary Care, University of Otago, Wellington, NZ
Grainger, R., Department of Medicine, University of Otago, Wellington, NZ
Gray, A., Department of Preventive Medicine, University of Otago, Dunedin, NZ
Hempel, D., Pain Management Service, Capital and Coast District Health Board, Wellington, NZ
Ingham, T., Department of Medicine, University of Otago, Wellington, NZ
Jones, B., Department of Medicine, University of Otago, Wellington, NZ
Saipe, B., Pain Management Service, Capital and Coast District Health Board, Wellington, NZ
Shipton, E.A., Christchurch Pain Management Services, Christchurch, NZ
Hale, L.A., Centre for Health, Activity, and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago, Dunedin, NZ
Introduction
Current best practice recommends group-based pain management programmes (PMPs) for long-term improvements in chronic non-cancer pain-related disability.
Aims
This non-inferiority trial aims to evaluate the clinical and cost-effectiveness of a group-based, online-delivered PMP (iSelf-help) compared to in-person PMP in reducing pain-related disability.
Methods
The iSelf-help non-inferiority randomised controlled trial is a pragmatic, assessor-blinded, two-arm RCT. Adults (age ≥18 years) with chronic non-cancer pain referred to a tertiary pain service deemed eligible for a PMP were recruited and block randomised to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help group participated in two 60-minute video-conferencing sessions weekly for 12 weeks (first session led by a peer-support facilitator with lived experience of pain; second session led by clinician) with access to resources via smartphone application and a password-protected website. The control participants received 12-week group-based, in-person PMP.
Results
We recruited 113 participants (56 iSelf-help and 57 in person) with a mean age of 38.2 (13.7) years. The participants were 75% (n=85) female, 8% (n=9 gender diverse), 16% (n=18) Māori. Based on an Intention to treat analysis on the primary outcome (Modified Roland Morris Disability Questionnaire) at six months (N=73), iSelf-help was non-inferior to the in-person group with a point estimate of -0.4 (∞, 1.5). It was also non-inferior for the secondary outcomes of Anxiety, Depression, Stress, Activity interference, Quality of life and Self-efficacy.
Conclusions
This is the first on-line delivered group PMP, culturally tailored to Māori with comparable clinical effectiveness in improving pain-related disability in people with chronic non-cancer pain.
Devan, H., Rehabilitation Teaching and Research Unit (RTRU), Department of Medicine, University of Otago, Wellington, NZ
Perry, M.A., Centre for Health, Activity, and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago, Wellington, NZ
Davies, C., Tū Kotahi Māori Asthma and Research Trust, Wellington, NZ
Dean, S., University of Exeter, Exeter, United Kingdom
Dowell, A., Department of Primary Care, University of Otago, Wellington, NZ
Grainger, R., Department of Medicine, University of Otago, Wellington, NZ
Gray, A., Department of Preventive Medicine, University of Otago, Dunedin, NZ
Hempel, D., Pain Management Service, Capital and Coast District Health Board, Wellington, NZ
Ingham, T., Department of Medicine, University of Otago, Wellington, NZ
Jones, B., Department of Medicine, University of Otago, Wellington, NZ
Saipe, B., Pain Management Service, Capital and Coast District Health Board, Wellington, NZ
Shipton, E.A., Christchurch Pain Management Services, Christchurch, NZ
Hale, L.A., Centre for Health, Activity, and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago, Dunedin, NZ
Introduction
Current best practice recommends group-based pain management programmes (PMPs) for long-term improvements in chronic non-cancer pain-related disability.
Aims
This non-inferiority trial aims to evaluate the clinical and cost-effectiveness of a group-based, online-delivered PMP (iSelf-help) compared to in-person PMP in reducing pain-related disability.
Methods
The iSelf-help non-inferiority randomised controlled trial is a pragmatic, assessor-blinded, two-arm RCT. Adults (age ≥18 years) with chronic non-cancer pain referred to a tertiary pain service deemed eligible for a PMP were recruited and block randomised to intervention (iSelf-help) and control groups (in-person PMP). The iSelf-help group participated in two 60-minute video-conferencing sessions weekly for 12 weeks (first session led by a peer-support facilitator with lived experience of pain; second session led by clinician) with access to resources via smartphone application and a password-protected website. The control participants received 12-week group-based, in-person PMP.
Results
We recruited 113 participants (56 iSelf-help and 57 in person) with a mean age of 38.2 (13.7) years. The participants were 75% (n=85) female, 8% (n=9 gender diverse), 16% (n=18) Māori. Based on an Intention to treat analysis on the primary outcome (Modified Roland Morris Disability Questionnaire) at six months (N=73), iSelf-help was non-inferior to the in-person group with a point estimate of -0.4 (∞, 1.5). It was also non-inferior for the secondary outcomes of Anxiety, Depression, Stress, Activity interference, Quality of life and Self-efficacy.
Conclusions
This is the first on-line delivered group PMP, culturally tailored to Māori with comparable clinical effectiveness in improving pain-related disability in people with chronic non-cancer pain.