A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

Abstract

Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted. We aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization. This is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023. The researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023. Our trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services. Brazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/. PRR1-10.2196/31345.