Post-Acute COVID-19 SyndromeROMPSNCT06016543
Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms
An observational study of Post-Acute COVID-19 Syndrome, run by A.T. Still University of Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- What is being tested?
- osteopathic manipulative treatment (OMT)
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to 10 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of clinics in the United States where members of the practice-based research network, DO-Touch.NET, practice osteopathic manipulative treatment.
Who may be able to join
- 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
Who cannot join
- unable to speak, read, and write in English
- not mentally competent to give informed consent
- inability to complete surveys/questionnaires online
Trial locations and contacts
1 site in 1 country.
United States1 site
Osteopathic Manipulative Medicine Gutensohn Clinic
Kirksville, Missouri, 63501
About this study
Official title: Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms - A Pilot Prospective Cohort Study
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:
- 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)?
- 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?
Read more
Participants will receive OMT as directed by their physician and complete questionnaires after every other OMT session.
- 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.
- Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first.
- 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
- Being tested
- osteopathic manipulative treatment (OMT)
- Keywords
- osteopathic manipulative treatment, long COVID, post-COVID conditions, post-acute sequelae of SARS-CoV-2 infection
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic manipulative treatment (OMT)Procedure or surgery
Osteopathic manipulative treatment provided at the discretion of the treating physician and based on the patient's response to previous treatments.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Data completion rate (feasibility)
Proportions of participants and physicians who complete all their questionnaires.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Neurocognitive and psychological symptoms
Measured using the Rivermead Post Concussion Symptoms Questionnaire
Measured: 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
Measured using the Long COVID-Household Pulse Survey
Measured: 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
Measured using the PROMIS SF v1.2 Global Health scale
Measured: 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
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.
Measured: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start18 Sep 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Sponsor
- Investigators
- Brian F Degenhardt, DO, Principal investigator, A.T. Still University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016543
- Sponsor's protocol ID
- ROMPS-Pilot
- Acronym
- ROMPS
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms - A Pilot Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06016543
- Acronym / sponsor ID
- ROMPS / ROMPS-Pilot
- Conditions
- Post-Acute COVID-19 Syndrome
- Keywords
- osteopathic manipulative treatment, long COVID, post-COVID conditions, post-acute sequelae of SARS-CoV-2 infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- 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.
- 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.
- Participants will be sent links to the questionnaires for 4 months or when their symptoms resolve, whichever comes first.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of clinics in the United States where members of the practice-based research network, DO-Touch.NET, practice osteopathic manipulative treatment.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- unable to speak, read, and write in English
- not mentally competent to give informed consent
- inability to complete surveys/questionnaires online
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | – |
Primary outcome
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.
Data completion rate (feasibility)
Time frame: Through study completion, an average of 1 year
Proportions of participants and physicians who complete all their questionnaires.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian F Degenhardt, DO principal investigator
A.T. Still University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Acute COVID-19 Syndrome, run by A.T. Still University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recruitment rate (feasibility) (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.