Post-Acute COVID-19 Syndrome
Conditions
Keywords
osteopathic manipulative treatment, long COVID, post-COVID conditions, post-acute sequelae of SARS-CoV-2 infection
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.
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.
Sponsors
American Osteopathic Association
A.T. Still University of Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data completion rate (feasibility) | Through study completion, an average of 1 year | Proportions of participants and physicians who complete all their questionnaires. |
| Patient recruitment rate (feasibility) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Measured using the Long COVID-Household Pulse Survey |
| 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 | 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. |
| 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 | Measured using the PROMIS SF v1.2 Global Health scale |
| 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 | Measured using the Rivermead Post Concussion Symptoms Questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Severity of potential adverse events from OMT | 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. |
Countries
United States
Outcome results
None listed