Osteopathic Manipulative Therapy for Long COVID

Overseen By Rebecca Lynn, DO, Doctor of Osteopathic Medicine

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

20 Participants Needed

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

Research Team

Darryl Kaelin, MD, Medical Doctorate (US)

Principal Investigator

University of Louisville School of Medicine Chair of PM&R Division of the Department of Neurological Surgery

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.

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

Treatment Details

Interventions

• Osteopathic Manipulative Therapy

Trial Overview 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.

Participant Groups

Group I: OMT treatment Experimental Treatment 2 Interventions

Participants will undergo OMT protocol that has been shown to improve Long-COVID smell intensity

Group II: OMT sham Placebo Group 1 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".

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+