NMM/OMTORIGINAL ARTICLE
Abstract
Context: The postacute sequelae of SARS-CoV-2 (PASC) are unexpected consequences of COVID-19 infections. Many patients continue to have PASC-related symptoms weeks to months after an infection, experiencing morbidity that affects daily living. Historically, many symptoms associated with PASC have been responsive to osteopathic manipulative medicine (OMM).
Objectives: To develop and disseminate a standardized clinical protocol for evaluating the efficacy of osteopathic manipulative treatment (OMT) in managing PASC. This study will assess OMT’s impact on symptoms and functional outcomes while systematically monitoring for adverse events (AEs) within this patient population.
Methods: The protocol is a prospective, single-arm, pre-post treatment cohort study involving patients seeking OMT with PASC-related symptoms. Standardized outcome measures have been selected to assess PASC-related symptoms and lifestyle impact over a 6-month longitudinal period. Data collection will occur at enrollment (baseline), at every second OMT session, and at a final follow-up. This final assessment will be conducted either 6 months postenrollment or 2 months after the cessation of treatment, whichever occurs first. Pragmatic, personalized OMT based on the physicians’ clinical findings and judgment is recommended to provide a realistic assessment of real-world OMT practice vs. a protocol-based intervention. The design developers recommend utilizing a web-based, HIPAA-compliant platform such as Research Electronic Data Capture (REDCap) to facilitate informed consent procedures, disperse and collect surveys, provide reminders for completing surveys, and store and manage data.
Results: At baseline, participants will provide demographic and clinical data, including age, sex, race, smoking and employment status, pre-COVID-19 health status, and comorbidities. We will also document symptoms and treatments associated with their acute COVID-19 illness. Descriptive statistics will summarize baseline characteristics. Longitudinal outcomes – encompassing neurocognitive function, physical symptoms, quality of life, and work status – will be analyzed utilizing generalized linear mixed models (GLMMs). This approach accounts for clinician-level clustering and adjusts for potential confounding variables while monitoring for adverse effects.
Conclusions: This protocol provides a standardized, pragmatic framework to evaluate the impact of OMT on the multifaceted symptoms of PASC. By utilizing a longitudinal, real-world design and robust statistical modeling (GLMM), the study aims to establish evidence-based insights into how osteopathic intervention can improve functional outcomes and quality of life for PASC patients. Furthermore, this standardized approach facilitates multi-site collaboration, ensuring that findings are reproducible and scalable within the broader medical community.