Effect of Standard Physical Exercises for Non-specific Low Back Pain Combined with Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity: A Study Protocol for a Randomized Controlled Trial
Caroline Razera Ferreira
Physical Therapy Departament, Universidade Nove de Julho, Postgraduate Program in Rehabilitation Sciences, São Paulo, Brazil.
Julia Picinini Hort
Colégio Brasileiro de Osteopatia, Sorocaba, Brazil.
Lívia Amaral Bezerra
Colégio Brasileiro de Osteopatia, Sorocaba, Brazil.
Hugo Pasin Neto
Colégio Brasileiro de Osteopatia, Sorocaba, Brazil.
Daniela Aparecida Biasotto-Gonzalez
Physical Therapy Departament, Universidade Nove de Julho, Postgraduate Program in Rehabilitation Sciences, São Paulo, Brazil.
Fabiano Politti *
Physical Therapy Departament, Universidade Nove de Julho, Postgraduate Program in Rehabilitation Sciences, São Paulo, Brazil.
*Author to whom correspondence should be addressed.
Abstract
Aims: The aim of the proposed study is to determine the effect of a standard treatment for non-specific low back (CNSLBP) combined with multimodal osteopathy treatment on pain intensity and functional capacity.
Materials and Methods: This will be a blind randomized clinical trial, with 44 patients with CNSLBP, randomly assigned into two groups: Experimental group (EG) treated with therapeutic exercises and multimodal osteopathy treatment (n=22) and Control group (CG) treated with therapeutic exercises (n=22). Participants will receive treatment twice a week (total of 16 sessions). The primary outcome is pain, measured by numeric rating scale (NRS: score 0-11 points). Secondary outcomes are: Patient-specific functional scale (scored from 0 to 30), Oswestry Disability Questionnaire (ODQ), finger-to-floor distance test (FFD). Participants will be evaluated pre- and post-treatment and after 1 and 3 months (follow-up).
Results: Analysis will be by intention to treat using linear mixed models. Comparisons between groups before and after treatment will demonstrate whether osteopathy treatment exerts a supplementary effect on pain and functional capacity in patients with CNSLBP. The data will be published after the study is completed. The study will support the practice of evidence-based physical therapy for individuals with CNSLBP. This protocol was registered (NCT06566144) and received ethical approval (CAEE: 6.275.345).
Keywords: Chronic non-specific neck pain, physical therapy, exercise therapy, osteopathy