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

NCT ID: NCT06016543

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-07-10

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:

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.

Detailed Description

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Conditions

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Post-Acute COVID-19 Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Osteopathic Association

OTHER

Sponsor Role collaborator

A.T. Still University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian F Degenhardt, DO

Role: PRINCIPAL_INVESTIGATOR

A.T. Still University of Health Sciences

Locations

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Osteopathic Manipulative Medicine Gutensohn Clinic

Kirksville, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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ROMPS-Pilot

Identifier Type: -

Identifier Source: org_study_id

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