Osteopathy and physiotherapy compared to physiotherapy alone on fatigue in long COVID: Study protocol for a pragmatic randomized controlled superiority trial

OBJECTIVE: Fatigue is among the most common symptoms of the long-term effects of coronavirus (long COVID). 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 two-arm, 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, viceral 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). REGISTRATION: This protocol was registered (NCT05012826) and received ethical approval (38342520.7.0000.5235). Participant recruitment began in August 2021 and is expected to conclude in July 2023. Publication of the results is anticipated in 2023.