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

Disqualifiers: Fractured bones, Other trials, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Osteopathic Manipulative Therapy (OMT) can improve various symptoms of Long COVID. It seeks to determine if two treatments are more effective than one in alleviating symptoms such as difficulty breathing, muscle pain, or fatigue. Participants will receive either a real or sham (placebo) OMT treatment to compare results. This trial is open to individuals who tested positive for COVID-19 over six weeks ago and continue to experience symptoms affecting daily life. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to new treatment options for Long COVID.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this OMT protocol is safe for Long-COVID patients?

Research has shown that Osteopathic Manipulative Therapy (OMT) is generally safe. In past studies, just one session of OMT improved heart rate variability in individuals with Long COVID. This improvement is promising because heart rate variability indicates healthy nervous system function.

OMT has also helped people with Long COVID regain their sense of smell, with no major side effects reported in these studies. Since OMT involves hands-on techniques, it is usually safe, especially when performed by trained professionals.

OMT has been used for other health issues for a long time, which supports its safety for new uses like Long COVID. However, as with any treatment, experiences can differ, so discussing potential risks with a healthcare provider is always wise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manipulative Therapy (OMT) for Long COVID because it offers a hands-on approach that may improve symptoms like diminished smell, which many current pharmacological treatments don't specifically address. Unlike medications that often focus on managing the broader symptoms of Long COVID, OMT involves targeted physical manipulation techniques that may enhance the body's natural healing processes. This therapy could provide a drug-free alternative, reducing the risk of side effects associated with medications. Additionally, the OMT sham arm in the trial helps establish the specific effectiveness of targeted OMT, as participants receive a form of therapy that mimics the treatment without the specific Long COVID focus, ensuring any benefits are due to the targeted approach.

What evidence suggests that this OMT protocol is effective for Long-COVID symptoms?

Studies have shown that Osteopathic Manipulative Therapy (OMT) can alleviate symptoms of Long COVID. One study found that a single OMT session improved heart rate variability, indicating better balance in the body's automatic functions for those with Long COVID-related fatigue. Another study demonstrated that OMT helped individuals regain their sense of smell after COVID-19. This trial will compare an OMT treatment protocol specifically targeting Long COVID symptoms with a sham OMT protocol that does not target these areas. Early results appear promising, but further research is necessary to confirm these benefits. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12429670/

Acute Effects of Osteopathic Treatment in Long COVID-19 ... Conclusions: A single session of osteopathic treatment significantly enhanced short-term heart rate variability in long COVID patients with fatigue. These ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05112887

Osteopathic Manipulative Therapy Effects on Prolonged ... The goal of this project is to determine the efficacy of a treatment method that increase a participants sense of smell after suffering from COVID-19 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06883513/osteopathic-manipulative-therapy-effects-on-post-acute-sequelae-of-covid-19-pasc-or-long-covid

Osteopathic Manipulative Therapy Effects on Post-Acute ... This study is investigating the effects of using an Osteopathic Manipulative Therapy (OMT) treatment protocol that was shown to statistically improve smell.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1746068922000438

A long COVID patient and their experience of osteopathic ... This case report contributes a twelve-month history of a female patient's experience of Long COVID and her motivation for, experience of and response to ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40943825/

Acute Effects of Osteopathic Treatment in Long COVID-19 ... Osteopathic manipulative treatment is a manual therapeutic approach that targets autonomic balance and may offer a novel intervention for long ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1746068922000190

Osteopathy and physiotherapy compared to ... This study aims to compare the effectiveness of osteopathic manipulative treatment (OMT) combined with physiotherapy treatment (PT) compared to PT alone on ...