Osteopathic Manipulative Therapy for Long COVID
Recruiting in Palo Alto (17 mi)
Overseen byDarryl Kaelin, MD, Medical Doctorate (US)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Louisville
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is investigating the effects of using an Osteopathic Manipulative Therapy (OMT) treatment protocol that was shown to statistically improve smell in individuals suffering from Long-COVID olfactory (smell) dysfunction in a small single-blinded pilot trial conducted during 2021.
The questions this study is trying to answer are:
1. Does this OMT protocol improve other non-smell related Long-COVID symptoms
2. Do 2 OMT treatments improve Long-COVID symptoms more than 1 OMT treatment
Participants will:
1. Week 1: Take an digital survey regarding their Long-COVID symptoms undergo Long-COVID OMT treatment or a placebo treatment
2. Week 2: Take an digital survey regarding their Long-COVID symptoms then all will undergo Long-COVID OMT treatment
3. Week 3: Take an digital survey regarding their Long-COVID symptoms
4. Week 8: Take an digital survey regarding their Long-COVID symptoms
Eligibility Criteria
This trial is for individuals experiencing Long COVID symptoms. Participants will be asked to complete digital surveys about their symptoms and receive Osteopathic Manipulative Therapy (OMT). Specific eligibility criteria are not provided, but typically include having Long COVID and being able to undergo OMT.Inclusion Criteria
Individuals must claim they have had a prior positive SARS-CoV-2 test at least 6-weeks before the consenting process to proceed with the study
I have long-lasting symptoms after an infection that disrupt my daily life.
Exclusion Criteria
If anyone denies they have any of the above symptoms before consent, they will be excluded from the trial
Participants enrolled in other Long-COVID trials that have an intervention during their participation in this trial will be excluded. However, participants with a history of enrollment in a long-covid trial that has no interventions during this trial will not be excluded based on their history of acquiring experimental treatment
I have not had any broken bones in the last 3 months.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Treatment
Participants undergo Long-COVID OMT treatment or a placebo treatment, followed by a second OMT treatment for all participants
2 weeks
2 visits (in-person)
Follow-up
Participants take digital surveys regarding their Long-COVID symptoms and are monitored for changes in symptom burden
6 weeks
2 virtual surveys
Participant Groups
The study tests whether a specific OMT protocol can improve non-smell related Long-COVID symptoms and if two treatments are more effective than one. All participants initially receive either the targeted OMT or a placebo treatment, followed by the actual OMT in subsequent weeks.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OMT treatmentExperimental Treatment2 Interventions
Participants will undergo OMT protocol that has been shown to improve Long-COVID smell intensity
Group II: OMT shamPlacebo Group1 Intervention
Participants will undergo an OMT treatment sequence that is not targeting areas that was targeted by the OMT treatment group. This will still be OMT, just not Long-COVID targeted OMT. Individuals who have had OMT before study will still be receiving treatment so they will be "blinded".
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Louisville Outpatient Care CenterLouisville, KY
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Who Is Running the Clinical Trial?
University of LouisvilleLead Sponsor