Immediate Effects of Spinal Manipulation on Painful Sensitivity and Postural Stability in Patients with Chronic Nonspecific Low Back Pain: Study Protocol for A Controlled Randomised Clinical Trial.

Abstract Background: Low back pain is one of the main public health concerns. Chronic low back pain (cLBP)reduces functional capacity and affects postural stability.Although health professionals widely use spinal manipulation, its immediate effect on painful sensitivity and postural stability is lacking. This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP. Methods: A two-arm, placebo-controlled clinical trial with parallel groups and examiner-blinded will be conducted with 80 participants with cLBPfrom an outpatient physical therapy department,randomly allocated at a 1:1 distribution. The experimental group will receive a lumbar spinal manipulation technique, and the placebo group will receive a simulated lumbar spinal manipulation. Both groups will receive one session of treatment and will be evaluated before and immediately after the intervention.The primary outcomes will be the pressure pain threshold and postural stability. Pain intensity and patient´s expectation will be assessed as a secondary outcome. The pressure pain threshold will be assessed using a pressure algometer in 6 different anatomical regions. The evaluation of postural stability will be performed in a baropodometry exam by displacing the centre of pressure. The pain intensity will be measuredusing the Numeric Pain Rating Scale. A Likert scale will be used for the patient´s expectationabout the treatment. A two-way analysis of variance will compare the effect of the interventions between groups. Discussion:This study will provide insights regarding the immediate effects of spinal manipulation in patients with cLBPagainst a simulated spinal manipulation using objective outcomes and considering patients’ expectations regarding the treatment.Trial registration: Brazilian Registry of Clinical Trials:RBR-3ksq2c; registered on 13 July 2020.