An internet-based intervention for chronic low back pain in primary health care for low- and middle-income individuals: a mixed methods feasibility study protocol (TECLI study)

Background: Nonspecific chronic low back pain (LBP) is a major contributor to disability and economic burden worldwide, particularly in low- and middle-income regions. Telehealth has emerged as a promising approach to improving healthcare accessibility and treatment effectiveness. This study aims to assess the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effectiveness and equity of a telehealth-delivered exercise and pain education program compared to an in-person intervention and a waitlist control group. Methods: This protocol describes a feasibility study with a sequential explanatory mixed-methods design, developed to inform a future three-arm RCT with economic evaluation. A total of 39 participants with chronic non-specific LBP will be recruited from Fortaleza, Brazil. Key feasibility indicators (e.g., recruitment rate, adherence, acceptability) and clinical outcomes (pain intensity, disability, quality of life, etc.) will be assessed at baseline and post-treatment (8 weeks). Discussion: The integrated findings will determine the feasibility of proceeding with a definitive trial designed to evaluate the effectiveness, cost-effectiveness, and equity of this telehealth model. This study is crucial for developing and scaling up evidence-based telehealth strategies that are not only effective, but also affordable and accessible for vulnerable populations with chronic low back pain in low-resource settings. Trial Registration: www.ensaiosclinicos.gov.br (RBR-4d7kgrw) on April 2, 2024.