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

利用心理生理生物标志物评估表面肌电生物反馈作为缓解慢性腰痛替代疗法的有效性:一项随机对照试验方案

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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.

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