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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT06883513
Status
Recruiting

Conditions

  • Long COVID Syndrome
  • Long-COVID
  • PASC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osteopathic Manipulative Therapy Long-COVID protocol — OTHER
    1. Rib Raising 2. Suboccipital Release 3. Thoracic Inlet Release 4. Miller Pump 5. Pedal Pump 6. Suboccipital Release 7. Cranial Sequence of Sinus Effleurage followed by indirect force within vault hold
  • Osteopathic Manipulative Therapy NOT Long-COVID treatment protocol — OTHER
    1. Bilateral Trapezius Direct Myofascial Release 2. Still's technique of the First rib Bilaterally: 3. Hamstring Muscle Energy

Study Details

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

Key Dates

Start date
May 1, 2025
Status verified
Mar 2025
Primary completion
Jul 3, 2025
Completion
Jul 3, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: OMT treatment
    Participants will undergo OMT protocol that has been shown to improve Long-COVID smell intensity
  • Sham Comparator: OMT sham
    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".

Primary Outcome Measure

The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) [ Time Frame: On arrival for baseline before any treatment (week 1). On arrival for 2nd treatment (week 2). 7 days after 2nd treatment (week 3). Final Survey on week 8 of post-enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Louisville Outpatient Care CenterLouisvilleKentucky40202
Jessie Mora, MA
1-502-965-8797
Michael Stenta, DO, Doctor of Osteopathic Medicine
5137289344
Michael Stenta, Doctor of Osteopathic Medicine (SUB_INVESTIGATOR)

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