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

• Sponsor: A.T. Still University of Health Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06016543
• Collaborator: American Osteopathic Association (Other)
• Enrollment: 120
• Anticipated Duration (Months): 17

Study Details

Study Description

Brief Summary

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:

1. 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)?

2. 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.

1. 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.

2. Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first.

3. 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.

Condition or Disease	Intervention/Treatment	Phase
Post-Acute COVID-19 Syndrome	Procedure: osteopathic manipulative treatment (OMT)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms - A Pilot Prospective Cohort Study
• Anticipated Study Start Date: Sep 18, 2023
• Anticipated Primary Completion Date: Sep 17, 2024
• Anticipated Study Completion Date: Feb 17, 2025

Outcome Measures

Primary Outcome Measures

1. Patient recruitment rate (feasibility) [Through study completion, an average of 1 year]

   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.

2. Data completion rate (feasibility) [Through study completion, an average of 1 year]

   Proportions of participants and physicians who complete all their questionnaires.

Secondary Outcome Measures

1. Neurocognitive and psychological symptoms [3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session]

   Measured using the Rivermead Post Concussion Symptoms Questionnaire

2. Physical symptoms [3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session]

   Measured using the Long COVID-Household Pulse Survey

3. Global health [3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session]

   Measured using the PROMIS SF v1.2 Global Health scale

4. 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]

   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.

Other Outcome Measures

1. Severity of potential adverse events from OMT [3 days after every other OMT session for up to 4 months after enrollment]

   Measured by comparing the severity of potential adverse events from OMT during the 3 days following OMT to the severity during the week before OMT.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• A.T. Still University of Health Sciences
• American Osteopathic Association

Investigators

• Principal Investigator: Brian F Degenhardt, DO, A.T. Still University of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: A.T. Still University of Health Sciences
• ClinicalTrials.gov Identifier: NCT06016543
• Other Study ID Numbers: ROMPS-Pilot
• First Posted: Aug 29, 2023
• Last Update Posted: Aug 29, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by A.T. Still University of Health Sciences: osteopathic manipulative treatment; long COVID; post-COVID conditions; post-acute sequelae of SARS-CoV-2 infection
• Additional relevant MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome

Study Results

No Results Posted as of Aug 29, 2023