A study protocol for a randomised controlled trial on the efficacy of yoga as an adjuvant therapy for patients with Ankylosing spondylitis amidst COVID-19 pandemic

Abstract

BackgroundAmidst the adversities of the COVID-19 pandemic, the health care system has seen a new paradigm shift towards e-health or telehealth services. In the advent of catering to the geometrically increasing health care needs of the patients suffering from various chronic health conditions when in social isolation, the need for such shifts is paramount. Patients with Ankylosing spondylitis using immunosuppressants with variable degrees of disabilities are at higher risk from this isolated status. This study aims to assess the efficacy of e-Yoga as a treatment option for these patients. MethodsThe proposed study is a single-center, parallel-group prospective randomized, open-blinded end-point trial. Patients aged between 30 and 50 years will be recruited from the members of Antardhwani: A society of ankylosing spondylitis based in Ahmedabad, Gujarat. Yoga experts will administer a scientifically developed and validated Yoga module via e-Yoga modalities. A total of 135 patients will be recruited and randomly allocated to Yoga and control groups. Data will be recorded at baseline and three months on disease activity, degree of functional limitations in patients, quality of life, inflammatory biomarkers, depression, and anxiety using Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), AS Quality of Life index (ASQOL), C reactive protein (CRP), Erythrocyte sedimentation rate (ESR), Physical health questionnaire-4 (PHQ-4), respectively. DiscussionThe study will report the efficacy of e-Yoga in catering to the physical and mental insufficiencies of inpatients with Ankylosing spondylitis amidst COVID-19 pandemic. The study is prospectively registered in the Clinical Trial Registry of India (CTRI/2020/08/027215)