Feasibility of evaluating the effectiveness of an interprofessional rehabilitation program for people with chronic low back pain in Ethiopia: a pilot randomized control trial protocol.

backgroundChronic low back pain (CLBP) is a significant public health problem and the leading cause of years lived with disability globally. Evidence suggests that interprofessional rehabilitation programs are effective for people with CLBP in improving health-related quality of life, reducing pain, and improving function and work abilities for people with CLBP. So far, however, little attention has been given to interprofessional rehabilitation programs for people with CLBP in low- and middle-income countries. Hence, this pilot randomized control trial (RCT) aims to evaluate the feasibility of conducting a future fully powered RCT to assess the effectiveness of an interprofessional rehabilitation program compared to the usual care for people with CLBP in Ethiopia.

methodsA two-arm parallel pilot RCT, with embedded mixed methods process evaluation, will be employed. A total of 40 patients with CLBP will be randomly assigned to the intervention and control groups at a 1:1 ratio. Participants of the intervention group will receive interprofessional rehabilitation that contains progressive physical activity and exercise, pain education, psychological interventions, and task-oriented and ergonomic interventions components. The comparison group participants will receive usual care for the same 4-week period. The primary outcome will be the feasibility of trial procedures (recruitment rate, retention rate, adherence rate, and acceptability of intervention). Secondary outcomes include the outcomes planned for the full trial, including physical functioning, pain intensity, pain self-efficacy, and health-related quality of life. Results will be analyzed and reported using descriptive statistics. The process evaluation will include a fidelity checklist, adherence measures, and qualitative interviews with 10 patients and all care providers involved to understand their experiences, barriers, and facilitators to implementing the intervention and trial methods with the goal of refining the intervention and trial methods in preparation for the fully powered trial. DISCUSSION: This pilot RCT will be critical to informing the methods, minimizing uncertainties, and increasing the likelihood of successfully conducting a definitive RCT in the future. In addition, it provides a source of evidence for other initiatives aimed at developing and implementing interprofessional rehabilitation programs in a similar context particularly in low- and middle-income countries.

trial registrationThis trial is registered at clinicaltrials.gov (registration number, NCT05866146, date of registration, 19th July 2023).