Is telerehabilitation inferior to face-to-face rehabilitation at improving adherence and pain in patients with chronic low back pain? Protocol for a non-inferiority randomized clinical trial with economic evaluation

Trials. 2026 May 21. doi: 10.1186/s13063-026-09795-0. Online ahead of print.

ABSTRACT

BACKGROUND: Exercise is a key component in reducing pain and disability in patients with chronic low back pain (CLBP). Barriers such as geographic distance, treatment costs, lack of support, and low self-efficacy can limit access to physiotherapy and compromise adherence. Synchronous telerehabilitation (ST) has the potential to overcome these barriers, support self-management, and improve adherence to exercise. However, its clinical effectiveness and cost-effectiveness compared with face-to-face rehabilitation remain unclear. This study aims to investigate whether ST is non-inferior to face-to-face rehabilitation in improving adherence and reducing pain and its cost-effectiveness in patients with CLBP.

METHODS: This non-inferiority randomized controlled trial (RCT), parallel, two-arm with economic evaluation, will be conducted in a middle-income country (Brazil). A total of 160 individuals with CLBP, aged between 18 and 65 years, will be recruited. Participants will be randomly allocated into two groups: ST or face-to-face rehabilitation. Both groups will receive seven individual 60-min physiotherapy sessions over 12 weeks, including pain education, exercise therapy, and self-management strategies. Primary outcomes will be adherence and pain intensity. Secondary outcomes will include function, global perception of change, satisfaction, self-efficacy, therapeutic alliance, healthcare attendance and health-related quality of life. Outcomes assessments will be conducted at baseline, post-intervention (3 month), and at 6- and 9-month follow-up after allocation. The economic evaluation will be conducted from a societal perspective with a 9-month time horizon. Cost-effectiveness and cost-utility analyses will be conducted for pain intensity and quality-adjusted life years, respectively.

DISCUSSION: If ST is non-inferior to face-to-face rehabilitation, it could serve as a clinically viable, cost-effective alternative for managing CLBP, expanding access to care while maintaining treatment quality. The findings may guide physiotherapists, healthcare systems, and policymakers in integrating telehealth strategies into routine rehabilitation practice.

TRIAL REGISTRATION: Brazilian Clinical Trials Registry ID: RBR-57pgmjr. Registered on November 13, 2025.

PMID:42169146 | DOI:10.1186/s13063-026-09795-0