Clinical trial NCT06016543: Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms
Official title: Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms - A Pilot Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Acute COVID-19 Syndrome
Keywords: osteopathic manipulative treatment
long COVID
post-COVID conditions
post-acute sequelae of SARS-CoV-2 infection
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2023-08-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient recruitment rate (feasibility)
timeFrame: Through study completion, an average of 1 year
measure: Data completion rate (feasibility)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Neurocognitive and psychological symptoms
timeFrame: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
measure: Physical symptoms
timeFrame: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
measure: Global health
timeFrame: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
measure: Return to work
timeFrame: 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:
measure: Severity of potential adverse events from OMT
timeFrame: 3 days after every other OMT session for up to 4 months after enrollment
Locations:
city: Kirksville
country: United States
facility: Osteopathic Manipulative Medicine Gutensohn Clinic
state: Missouri
Study officials:
affiliation: A.T. Still University of Health Sciences
name: Brian F Degenhardt, DO
role: PRINCIPAL_INVESTIGATOR
References: