Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms

Study Overview
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Brief Summary
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The goal of this observational study is to determine the feasibility of conducting a large-scale study on the effect of using osteopathic manipulative treatment (OMT) to treat patients with post-COVID-19 symptoms. The main questions it aims to answer are: Is it feasible to conduct a large-scale study of the effect of OMT on patients with post-COVID-19 symptoms (based on how many patients agree to participate and how many complete the study)? How much change in patients' post-COVID-19 symptom severity, quality of life, and ability to return to work can we expect to see following OMT? Participants will receive OMT as directed by their physician and complete questionnaires after every other OMT session. Participants will complete questionnaires about their post-COVID-19 symptoms, quality of life, ability to return to work, and adverse events they experienced 3 days after every other OMT session. Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first. Additionally, participants will complete a follow-up questionnaire 2 months after they stop receiving OMT for their post-COVID-19 symptoms or 6 months after enrollment in the study, whichever comes first.

Official Title
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Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms - A Pilot Prospective Cohort Study

Conditions
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Post-Acute COVID-19 Syndrome

Intervention / Treatment
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* Procedure: osteopathic manipulative treatment (OMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one symptom of post-COVID-19 (eg, fatigue, dyspnea, anosmia, arthralgia, headache, sleep disturbances, anxiety/depression, or other problems related to mental health) which was new after diagnosis with COVID-19 and has persisted for at least 4 weeks after diagnosis Exclusion Criteria: unable to speak, read, and write in English not mentally competent to give informed consent inability to complete surveys/questionnaires online

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: osteopathic manipulative treatment (OMT)|Osteopathic manipulative treatment provided at the discretion of the treating physician and based on the patient's response to previous treatments.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient recruitment rate (feasibility) | Proportion of patients who enroll in the study out of the number of patients who were eligible for and invited to enroll in the study. | Through study completion, an average of 1 year | 
| Data completion rate (feasibility) | Proportions of participants and physicians who complete all their questionnaires. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive and psychological symptoms | Measured using the Rivermead Post Concussion Symptoms Questionnaire | 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session | 
| Physical symptoms | Measured using the Long COVID-Household Pulse Survey | 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session | 
| Global health | Measured using the PROMIS SF v1.2 Global Health scale | 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session | 
| Return to work | For participants who were employed prior to COVID-19, their current working status will be assessed on a 4-point scale (1. returned to full-time work without restrictions, 2. returned to full-time work but with modified job duties, 3) returned to work but with reduced working hours, 4. have not been able to return to work. | 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteopathic manipulative treatment, long COVID, post-COVID conditions, post-acute sequelae of SARS-CoV-2 infection