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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Acute COVID-19 Syndrome
• Intervention / Treatment: Procedure: osteopathic manipulative treatment (OMT)

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • Osteopathic Manipulative Medicine Gutensohn Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients of clinics in the United States where members of the practice-based research network, DO-Touch.NET, practice osteopathic manipulative treatment.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of potential adverse events from OMT	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.	3 days after every other OMT session for up to 4 months after enrollment

Collaborators and Investigators

• Sponsor: A.T. Still University of Health Sciences
• Collaborators: American Osteopathic Association
• Investigators: Principal Investigator: Brian F Degenhardt, DO, A.T. Still University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: osteopathic manipulative treatment; long COVID; post-COVID conditions; post-acute sequelae of SARS-CoV-2 infection
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: ROMPS-Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No