NCT06883513 · University of Louisville
Osteopathic Manipulative Therapy Effects on Post-Acute Sequelae of COVID-19 (PASC) or Long COVID
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
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
OTHER
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 measures
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
The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) is a validated tool generated to assess for Long-COVID symptom burden generated by the University of Birmingham in the UK. The SBQ™-LC assesses 123 different symptoms of Long COVID. All items use the recall period "In the last 7 days..." and are scored according to one of the following: 1. symptom presence (Yes/No); 2. symptom frequency (0 = Never to 3 = Always); 3. symptom severity (0 = None to 3 = Severe); 4. or Interference in daily life (0 = Not at all to 3 = Severely). The SBQ™-LC has a Flesch-Kincaid Reading Grade level score of 5.33 suggesting it would be understood by a person with a 6th grade reading level according to the American education system. The SBQ™-LC's SMOG Index score of 8.27 means it should be understood by 93% of UK adults.(8-10) Higher scores suggest worsening symptom severity. Maximum raw score depends on which independent scale within the tool is measured. Ranges from 5-38 depending
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Altered Smell
- Changes in Skin
- Changes in bowels
- 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.
Where
- Louisville, Kentucky
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2025 · Source of record for eligibility and locations