Psychophysiological biomarkers to assess the effectiveness of surface electromyography biofeedback as an alternative therapy to reduce chronic low back pain: protocol for a randomised controlled trial.

Abstract

The prevalence of chronic low back pain (CLBP) among the Pakistani population is reported to be as high as 78%, leading towards different physiological and psychosocial alterations, with the worst cases suffering from disabilities. This study protocol will be a randomised controlled trial designed to compare the effectiveness of biofeedback surface electromyography (sEMG) for CLBP in the Pakistani population. This will be a single-centre study to be conducted on patients with CLBP randomised into two groups, namely, Group A (intervention group) and Group B (control group) to receive biofeedback sEMG therapy as an intervention or no intervention, respectively. All participants will receive treatment for 8 weeks virtually. The primary and secondary outcomes will be assessed during the study, including the pain intensity and interference (Brief Pain Inventory), anxiety and depression (State-Trait Anxiety Inventory (STAI)), disability (The Oswestry Disability Index (ODI)) and quality of life. Further, physiological parameters, including altered cortisol levels, beta-endorphins and substance P, will also be measured. All outcomes will be assessed at baseline, immediately post-intervention and 3 months follow-up.