Supervised versus Minimally Supervised Exercises on Pain, Function, and Quality of Life of Individuals with Chronic Non-Specific Neck Pain: A Non- Inferiority Randomized Clinical Trial Protocol

Background. Chronic non-specific neck pain (CNSNP) is a prevalent disorder and may be associated with neuromuscular changes. Physical exercises are one of the main non-pharmacological interventions to reduce pain and improve the function of individ- uals with CNSNP. Although the method of exercise application (i.e., supervised or mini- mally supervised) may facilitate clinical decision-making by health professionals, it needs to be verified and compared. The aim of this study is to investigate the non-inferiority of a minimally supervised versus supervised exercise program (with equal doses of training) on neck disability, pain intensity and quality of life of individuals with CNSNP. Methods. This randomized controlled trial will include 76 individuals with CNSNP aged 18-50 to perform an eight-week supervised or minimally supervised multimod- al exercise program. Outcome measures will be assessed at baseline and after 8 and 16 weeks. The primary outcome will be the neck disability. Secondary outcomes will include pain intensity, neck range of motion, muscle isometric strength, endurance, quality of life, kinesiophobia, catastrophizing, self-efficacy and global perceived effect. Results. This is the first study to investigate the non-inferiority of a minimally super- vised versus supervised exercise program (with equal training doses) on neck disability, pain intensity and quality of life of individuals with CNSNP. If successful, the find- ings of this study will clarify the importance of minimally supervised interventions for CNSNP, providing an additional approach to health professionals. Conclusions. This clinical trial was designed to able to reproduce an approach as a physiotherapist trained in multimodal exercise program would do. Study registration. The study has been prospectively registered in the Brazilian Regis- try of Clinical Trials (RBR-8bbz36g) at https://ensaiosclinicos.gov.br/rg/RBR-8bbz36g.