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Completed

NCT Number: NCT06016543

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Osteopathic Manipulative Medicine Gutensohn Clinic

Kirksville, Missouri, 63501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Patient recruitment rate (feasibility)

    Time frame: 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)

    Time frame: Through study completion, an average of 1 year

    Proportions of participants and physicians who complete all their questionnaires.

Secondary outcomes

  1. Neurocognitive and psychological symptoms

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Severity of potential adverse events from OMT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

A.T. Still University of Health Sciences

Other

Collaborators

  • American Osteopathic Association

Registry information

Official study title

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

Acronym: ROMPS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 29, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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