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

NCT06016543 | Completed

• 1 other identifier: ROMPS-Pilot
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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. 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. 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?
3. 3.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.
4. 4.Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first.
5. 5.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.

Conditions

Post-Acute COVID-19 Syndrome

Keywords

osteopathic manipulative treatment; long COVID; post-COVID conditions; post-acute sequelae of SARS-CoV-2 infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Severity of potential adverse events from OMT

  3 days after every other OMT session for up to 4 months after enrollment

Interventions

osteopathic manipulative treatment (OMT) PROCEDURE

Osteopathic manipulative treatment provided at the discretion of the treating physician and based on the patient's response to previous treatments.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• unable to speak, read, and write in English
• not mentally competent to give informed consent
• inability to complete surveys/questionnaires online

Sponsors & Collaborators

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

Study Sites (1)

Osteopathic Manipulative Medicine Gutensohn Clinic

Kirksville, Missouri, 63501, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Brian F Degenhardt, DO

  A.T. Still University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: September 18, 2023
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)