A group-based, online-delivered pain management programme (iSelf-help) is not inferior to a group-based, in-person programme in reducing pain-related disability for people with persistent pain: A non-inferiority randomised, two-arm, parallel, open-label trial

A group-based, online-delivered version (iSelf-help) of an existing group-based in-person pain management programme was developed. Development included Māori (New Zealand's Indigenous population) cultural considerations of content. This study determined whether offering iSelf-help was non-inferior to the in-person pain management programme in reducing pain-related disability at six months. The study used a non-inferiority randomised, two-arm, parallel, open-label trial with blinding of assessors, including health economic and process evaluations. Participants were adults (age≥18 years) with persistent non-cancer pain referred to a hospital-based regional pain service who were deemed eligible for a pain management programme. iSelf-help groups participated in two 60-minute video-conferencing sessions (first, peer support facilitated; second, clinician facilitated) weekly for 12 weeks with access to resources via smartphone app and website. In-person groups received 12-week in-person pain management programme. The primary outcome was the Modified Roland Morris Disability Questionnaire. Secondary outcomes included anxiety, depression, stress, pain severity and interference, health related quality of life, self-efficacy, acceptance, and satisfaction. Recruited were 113 participants (56 iSelf-help, 57 in-person), mean(SD) age 38.2(13.7) years, 75% female, 16% Māori. Using modified intention-to-treat analysis on the primary outcome at six months (n=73), iSelf-help was non-inferior to in-person pain management programme with a point estimate (95% one-sided CI) of -0.4 (∞, 1.5). It was also non-inferior for secondary outcomes of anxiety, depression, stress, activity interference, health related quality of life, and self-efficacy. iSelf-help was cheaper, had similar overall satisfaction, but higher accessibility, scores. iSelf-help showed non-inferior clinical outcomes for improving pain-related disability in people with persistent non-cancer pain. PERSPECTIVE: This article evaluates a novel online-delivered pain management programme (iSelf-help) co-created with people with persistent pain, with committed and ongoing collaboration with Māori whānau (Indigenous population of New Zealand). iSelf-help may improve access to the regional pain service used in this study for more people living with persistent pain.