Technology supported High Intensity Training in chronic non-specific low back pain (the Techno-HIT trial): study protocol of a randomised controlled trial

Abstract

Chronic low back pain (CLBP) is one of the most common chronic musculoskeletal disorders worldwide. Guidelines recommend exercise therapy (ET) in CLBP management, but more research is needed to investigate specific ET modalities and their underlying mechanisms. The primary goal of this study is to evaluate the short-term and long-term effectiveness of a time-contingent individualised high-intensity training (HIT) protocol on disability compared with a time-contingent moderate-intensity training (MIT) as used in usual care, in persons with severely disabling CLBP. Additionally, the effectiveness on central effects, the added value of prolonged training at home and technology support, and the cost-effectiveness are evaluated. In this randomised controlled trial, CLBP patients will be randomly divided into three groups of 56 participants. Group 1, 'TechnoHIT', receives HIT with technology-support in the home-phase. Group 2, 'HIT', receives HIT without technology support. Group 3, 'MIT', receives MIT, reflecting training intensity as used in usual care. The primary outcome is patient-reported disability, measured by the Modified Oswestry Disability Index. Secondary outcomes include quantitative sensory testing, psychosocial factors, broad physical fitness, quality of life, cost-effectiveness, adherence and usability of technology. Trial registration number NCT06491121.