Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06883513

Osteopathic Manipulative Therapy Effects on Post-Acute Sequelae of COVID-19 (PASC) or Long COVID

Led by University of Louisville · Updated on 2025-03-19

20

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effects of an Osteopathic Manipulative Therapy (OMT) protocol on individuals with Long-COVID, specifically those experiencing prolonged symptoms after COVID-19 infection. This study aims to determine if the OMT protocol, which previously showed improvement in smell dysfunction related to Long-COVID, can also improve other Long-COVID symptoms. It compares the effects of receiving one versus two OMT treatments on symptom burden over an 8-week period. Participants will be randomly assigned to either an experimental group receiving the targeted Long-COVID OMT protocol or a control group receiving a sham OMT treatment designed to mimic therapy without targeting Long-COVID areas. The experimental OMT consists of a sequence of seven specific manual techniques intended to stimulate nervous system regulation and improve lymphatic and vascular flow. The control treatment involves different OMT techniques not aimed at Long-COVID symptoms. Treatments are delivered in two consecutive weekly sessions. During the study, participants will complete a digital symptom survey called the Symptom Burden Questionnaire for Long COVID (SBQ2-LC) four times: at baseline before treatment, before the second treatment, one week after the second treatment, and at 8 weeks post-enrollment. Blood pressure and heart rate will be measured at each in-person treatment visit to monitor nervous system activity. Researchers will assess changes in Long-COVID symptom burden and physiological responses to understand the therapy's impact over time.

CONDITIONS

Brief Title

Osteopathic Manipulative Therapy Effects on Post-Acute Sequelae of COVID-19 (PASC) or Long COVID

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Prior positive SARS-CoV-2 test at least 6 weeks before enrolling
  • At least one ongoing Long-COVID symptom affecting daily life such as shortness of breath, muscle pain, fatigue, mood changes, altered smell or taste, cognitive difficulty, or others listed in the SBQ-LC
  • Willingness to complete symptom surveys and attend treatment visits
Not Eligible

You will not qualify if you...

  • Denial of any ongoing Long-COVID symptoms at enrollment
  • Fractured bones within the last 3 months
  • Current participation in other Long-COVID clinical trials with active interventions during this study period

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and baseline survey completion

Treatment

Duration - 2 weeks

Participants receive Osteopathic Manipulative Therapy (OMT) or sham OMT to evaluate effects on Long-COVID symptoms. The treatment aims to reduce symptom burden by improving lymphatic and vascular drainage and decreasing sympathetic tone.

2 in-person visits, one each week for treatment and assessments

Follow-up

Duration - 6 weeks post-treatment

Participants complete symptom surveys and have vital signs measured to assess Long-COVID symptom changes up to 8 weeks after initial treatment.

1 electronic survey 7 days after second treatment and 1 electronic survey at 8 weeks post initial treatment

Trial Site Locations

Total: 1 location

1

University of Louisville Outpatient Care Center

Louisville, Kentucky, United States, 40202

Actively Recruiting

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Research Team

M

Michael E Stenta, DO, Doctor of Osteopathic Medicine

R

Rebecca Lynn, DO, Doctor of Osteopathic Medicine

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Massive transient damage of the olfactory epithelium associated with infection of sustentacular cells by SARS-CoV-2 in golden Syrian hamsters.

Bertrand Bryche, Audrey St Albin, Severine Murri...

https://pubmed.ncbi.nlm.nih.gov/32629042

Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study.

Jerome R Lechien, Carlos M Chiesa-Estomba, Daniele R De Siati...

https://pubmed.ncbi.nlm.nih.gov/32253535