Abstract
Background: Current best practice recommends group-based pain management programmes (PMPs) for long-term improvements in persistent pain-related disability.
Purpose: 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 persistent 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-min video-conferencing sessions weekly for 12 weeks (first session led by a peer-support facilitator with lived experience of pain; second session led by clinicians) with access to resources via smartphone application and a password-protected website. Control participants received 12-week group-based, in-person PMP.
Results: We recruited 113 participants (56 iSelf-help and 57 in person) with a M (SD) 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. Programme delivery cost per patient was lower for iSelf-help participants. No serious adverse events were reported.
Conclusion: This is the first online delivered group-based PMP with comparable clinical effectiveness in improving pain-related disability in people with persistent pain.
Implications: iSelf-help provides an economic and safe alternative group-based pain management option with increased geographical reach. Theoretically, it could enable choice between their preference for in-person or online health service delivery, providing a more person-centred approach to pain management.