Effects of osteopathic manipulative treatment combined with physiotherapy treatment in adults with post-COVID-19 sequelae: A pragmatic randomized controlled trial

Abstract

Introduction: Fatigue is among the most common symptoms of the long-term effects of coronavirus (long COVID). Objective: This study aims to compare the effectiveness of osteopathic manipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PT alone on fatigue and functional limitations after two months post randomization in adults with long COVID. Methods: This is a study protocol for a twoarm, assessor-blinded, pragmatic randomized controlled superiority trial. Seventy-six
participants will be randomly allocated to OMT+PT or PT. The PT includes usual care interventions including motor and respiratory exercises targeting cardiorespiratory and skeletal muscle functions. The OMT entails direct and indirect musculoskeletal, visceral, and cranial techniques. Patients will be evaluated before and after a 2-month intervention program, and at 3-month follow-up session. Primary objectives comprise fatigue and functional limitations at 2-month post randomization as assessed by the
fatigue severity scale and the Post-COVID Functional State scale. Secondary objectives comprise fatigue and functional limitations at 3 months, and the perceived change post-treatment as assessed by the Perceived Change Scale (PCS-patient). Results: Preliminary data including 24 (32%) patients at baseline, 13 (17%) and 2 (3%) patients with assessments T2 (60 [60-63] days) and T3 (91 [91-91] days) completed were analyzed. There is statistical evidence of a difference between groups for both fatigue (FSS, P<0.01) and functional capacity (PCFS, P<0.01) outcomes at T2. No statistical evidence of a difference between groups was noticed for the global
perceived effect (PCS, P=0.74). Conclusion: Preliminary findings suggest an improvement in fatigue and functional limitations two-month post randomization in patients with long COVID. The trial continues patient recruitment up to July 2023 for a full analysis according to the published protocol.