BACKGROUND
Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise as a treatment is beneficial for the improvement quality of life (QOL) in these patients and it widely accepted as well.
OBJECTIVE
To develop a protocol for a feasibility study designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors in patients with chronic LBP after 8 weeks of randomization.
METHODS
This is a study protocol for a randomized controlled trial that consists of individuals with chronic LBP aged between 18 and 65 years. Subjects will be allocated through block randomization in one of the following groups: Motor Control Exercises (MCE), Pain Education, MCE + Pain Education, and Usual Care. The primary outcome will be pain intensity, and secondary outcomes will be pressure pain threshold measured through digital algometer, LBP-related disability, fears and beliefs, fear of movement, QOL, mood states, levels of depression and anxiety.
RESULTS
This trial was funded in 2018 and it was approved by Human Research Ethic Committee in September 2018. We are starting the patient’s recruitment, as it involves patients on a public service waiting list and needs the health manager's permission to start the data collection considering the current health scenario. Results are expected to be achieved by April 2022.
CONCLUSIONS
This trial will provide preliminary data regarding the feasibility and safety of MCE and Pain Education in patients with low back pain. It will also provide preliminary outcome data used to identify the intervention more efficient and what level of health care should be implemented in public health services.
CLINICALTRIAL
RBR-2xx2r2