Feasibility of an interprofessional rehabilitation program (IPRehab-LBP) for people with chronic low back pain in Ethiopia: an open-label pilot randomized controlled trial with an embedded process evaluation

Chronic low back pain (CLBP) is a major public health problem and a leading cause of years lived with disability worldwide. Although interprofessional rehabilitation is recommended for managing CLBP, its feasibility and implementation in low-resource settings, such as Ethiopia, remain largely unexplored. This study evaluated the feasibility of conducting a future definitive hybrid type I effectiveness-implementation trial comparing the Interprofessional Rehabilitation Program for Chronic Low Back Pain (IPRehab-LBP) with usual care. A two-arm, parallel-group, open-label pilot randomized controlled trial (RCT) with an embedded mixed-methods process evaluation was conducted. Forty adults with CLBP were randomized to IPRehab-LBP ( n = 20) or usual care ( n = 20). The 4-week IPRehab-LBP program included physical activity and exercise, pain education, cognitive behavioural therapy and psychosocial support, and task-oriented and ergonomic interventions. Primary feasibility outcomes included recruitment, retention, outcome-measure completion, and intervention fidelity. Exploratory clinical outcomes included disability, pain intensity, self-efficacy, and health-related quality of life. Outcomes were assessed at baseline, post-intervention, and 12-week follow-up. Linear mixed-effects models and ANCOVA were used to estimate between-group differences. Post-intervention interviews were conducted with 10 participants and five healthcare providers. Recruitment was 2.5 participants per week. Retention was 92.5% post-intervention and 87.5% at 12-week follow-up, while outcome-measure completion exceeded 99% at all assessment points. Intervention content fidelity was 89% (range, 77%–96%), with most fidelity criteria achieved except for session duration. Exploratory clinical outcome estimates generally favoured IPRehab-LBP; post-intervention disability was lower in the IPRehab-LBP group than in the usual care group (baseline-adjusted RMDQ mean difference, − 6.29; 95% CI, − 9.69 to − 2.89). The process evaluation indicated that the intervention was delivered largely as intended and was highly acceptable, while identifying contextual and implementation considerations to inform a future definitive trial. This pilot RCT supports the feasibility and acceptability of IPRehab-LBP within a tertiary healthcare setting in Ethiopia. Retention, outcome-measure completion, and most fidelity criteria were achieved; however, the prespecified recruitment rate and session-duration fidelity criteria were not met. The findings support progression to a definitive multi-site hybrid type I effectiveness-implementation trial with modifications, particularly to strengthen recruitment and facilitate intervention delivery within the planned session duration. ClinicalTrials.gov, NCT05866146. First submitted 18/04/2023; This study is retrospectively registered as Date of first enrolment: April 11, 2023.