ClinicalTrials.gg
CompletedNCT06016543ROMPSUpdated Jul 30, 2024

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

An observational study in Post-Acute COVID-19 Syndrome, sponsored by A.T. Still University of Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by A.T. Still University of Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 194 studies in Post-Acute COVID-19 Syndrome with a site in United States — 63 open to participants now, 84 under way, 7 of them phase 3. Post-Acute COVID-19 Syndrome · United States.

Enrollment
35th of 37
7 · median 155
Started
2023
with 52 others
Observational
37 of 194
16 open now
Registered
99th of 194
by date

Among the 194 studies in Post-Acute COVID-19 Syndrome with a site in United States, this one is the 35th largest by enrollment of the 37 observational ones that give a count, is one of 53 that started in 2023, is one of 37 observational ones, and was the 99th registered.

Post-Acute COVID-19 Syndrome

604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.

Browse Post-Acute COVID-19 Syndrome studies →

Open to participants now

63 of the 194 studies in Post-Acute COVID-19 Syndrome with a site in United States are open now. Recruiting first, the newest first:

58 more — sign in →

All 63 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 146 Post-Acute COVID-19 Syndrome studies recruiting now, 70 (48%) set no upper age limit and 53 (36%) stop at 75 or younger; 15 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.
03

Conditions studied

  • Post-Acute COVID-19 Syndrome

Keywords

  • osteopathic manipulative treatment
  • long COVID
  • post-COVID conditions
  • post-acute sequelae of SARS-CoV-2 infection
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • unable to speak, read, and write in English
  • not mentally competent to give
  • inability to complete surveys/questionnaires online
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No

Interventions

  • Procedureosteopathic manipulative treatment (OMT)

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. Data completion rate (feasibility)

    Proportions of participants and physicians who complete all their questionnaires.

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

Secondary outcomes

  1. Neurocognitive and psychological symptoms

    Measured using the Rivermead Post Concussion Symptoms Questionnaire

    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

  2. Physical symptoms

    Measured using the Long COVID-Household Pulse Survey

    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

  3. Global health

    Measured using the PROMIS SF v1.2 Global Health scale

    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

  4. 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.

    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

Other outcomes

  1. 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.

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

07

Study locations

1 site
  • Osteopathic Manipulative Medicine Gutensohn Clinic
    Kirksville, Missouri 63501, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in Jul 2024, 9 months.

Of 98 non-industry observational studies under Post-Acute COVID-19 Syndrome, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 39. This study's 9 months is below that.

Counting every sponsor, half of 105 studies reached it within 27 months; a quarter within 14 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2023
First posted
Aug 29, 2023
StartActual
Sep 18, 2023
Primary completionActual
Jul 10, 2024
CompletionActual
Jul 10, 2024
Last update
Jul 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06016543
Lead sponsor
A.T. Still University of Health Sciences
Collaborators
American Osteopathic Association
Responsible party
Sponsor
First posted
Aug 29, 2023
Start date
Sep 18, 2023
Primary completion
Jul 10, 2024
Completion
Jul 10, 2024
Last update
Jul 30, 2024

Study contacts

Brian F Degenhardt, DO
principal investigator · A.T. Still University of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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