Recruiting

Osteopathic Manipulative Therapy

Sponsor:

University of Louisville

Code:

NCT06883513

Conditions

Long-COVID

PASC

Long COVID Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Osteopathic Manipulative Therapy Long-COVID protocol

Osteopathic Manipulative Therapy NOT Long-COVID treatment protocol

Study Details

Brief summary:

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

Conditions

Long-COVID

PASC

Long COVID Syndrome

Study ID

NCT06883513

Start date

May 1, 2025

Status verified date

Mar, 2025

Completion date

Jul 3, 2025

Anticipated

Primary completion date

Jul 3, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Individuals must claim they have at least one of the following symptoms greater than 6-weeks post infection that is affecting their daily life(these symptoms correlate with the SBQ™-LC):

Symptoms of Long Covid Inclusion Criteria:

  • Shortness of breath or Difficulty Breathing
  • Difficulty with Movement (balance or tremor)
  • Muscle Pain or stiffness
  • Changes in sexual desire
  • Worsening Generalized Pain
  • Difficulty with Sleep
  • Changes in Mood (anxiety or depression)
  • Changes in Erectile function (Biological males only)
  • Palpations (irregular heart beats)
  • Altered Taste
  • Changes in your Hair
  • Changes in urination
  • Dizziness
  • Altered Smell
  • Changes in Skin
  • Changes in bowels
  • Fatigue
  • Indigestion
  • Dry or irritated eyes
  • Changes in sweating
  • Difficulty with Cognition (memory or thinking)
  • Stomach Pain
  • Changes in menstruation (Biological females only)
  • Chills or shivering

Exclusion Criteria:

  • If anyone denies they have any of the above symptoms before consent, they will be excluded from the trial

  • They will also be excluded from the trial if they have suffered any fractured bones in the last 3 months (this will further decrease risk to the patient as the patient will be moved by the physician during the treatment protocol)
  • Participants who are enrolled in other Long-COVID trials that have an intervention during their participation in this trial will be excluded. However, if they have a history of enrollment in a long-covid trial that has no interventions during this trial, they will not be excluded based on their history of acquiring experimental treatment.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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".

Interventions

Osteopathic Manipulative Therapy Long-COVID protocol

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

1. Bilateral Trapezius Direct Myofascial Release
2. Still's technique of the First rib Bilaterally:
3. Hamstring Muscle Energy

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 and Locations

Central contacts

Michael E Stenta, DO, Doctor of Osteopathic Medicine

15137289344michael.stenta@uoflhealth.org

Rebecca Lynn, DO, Doctor of Osteopathic Medicine

1-931-409-6699rebecca.lynn@uoflhealth.org

Locations

University of Louisville Outpatient Care Center

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Jessie Mora, MA

1-502-965-8797jessie.mora@uoflhealth.org

Michael Stenta, DO, Doctor of Osteopathic Medicine

5137289344michael.stenta@uoflhealth.org

More Information

Sponsor

University of Louisville

Last update posted

Mar 19, 2025

Last verified

Mar, 2025

Keywords

  • Long-COVID
  • PASC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2025-03-19.