Effects of transcranial direct current stimulation combined with Pilates-based exercises in the treatment of chronic low back pain in outpatient rehabilitation service in Brazil: double-blind randomised controlled trial protocol

Abstract

Introduction Chronic low back pain may be associated with pathoanatomical, neurophysiological, physical, psychological and social factors; thus, treatments to reduce symptoms are important to improve the quality of life of this population. We aimed to evaluate the effects of transcranial direct current stimulation (tDCS) combined with Pilates-based exercises compared with sham stimulation on pain, quality of life and disability in patients with chronic non-specific low back pain.Methods and analysis This is a protocol for a double-blind randomised controlled trial with participants, outcome assessor and statistician blinded. We will include 36 individuals with a history of non-specific chronic low back pain for more than 12 weeks and minimum pain intensity of 3 points on the Numerical Pain Rating Scale. Individuals will be randomised into two groups: (1) active tDCS combined with Pilates-based exercises and (2) sham tDCS combined with Pilates-based exercises. Three weekly sessions of the protocol will be provided for 4 weeks, and individuals will be submitted to three assessments: the first (T0) will be performed before the intervention protocol, the second (T1) immediately after the intervention protocol and the third (T2) will be a follow-up 1 month after the end of the intervention. We will assess pain, disability, central sensitisation, quality of life, pressure pain threshold, global impression of change, adverse events and medication use. The Numerical Pain Rating Scale and the Roland-Morris Disability Questionnaire will be used at T1 to assess pain and disability, respectively, as primary outcome measures.Ethics and dissemination This trial was prospectively registered in ClinicalTrials.gov website and ethically approved by the Ethics and Research Committee of the Faculty of Health Sciences of Trairi (report number: 5.411.244) before data collection. We will publish the results in a peer-reviewed medical journal and on institution websites.Trial registration number ClinicalTrials.gov (NCT05467566).