Osteopathic Manipulative Therapy Effects on Post-Acute Sequelae of COVID-19 (PASC) or Long COVID
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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
Shortness of breath or Difficulty Breathing
Difficulty with Movement (balance or tremor)
Muscle Pain or stiffness
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Osteopathic Manipulative Therapy Long-COVID protocol
Other intervention1. 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 intervention1. Bilateral Trapezius Direct Myofascial Release 2. Still's technique of the First rib Bilaterally: 3. Hamstring Muscle Energy
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: OMT treatmentExperimental treatment 2 interventions
Group B: OMT shamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC)
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
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-enrollmentSecondary outcomes
1
Blood Pressure(BP)
BP's will be taken before treatment regardless of arm participants are assigned at baseline. It will be repeated 10 minutes after the each treatment
Time frame
Each in-person treatment event, total of 1 BP at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 BP readings2
Heart Rate (HR)
HR's will be taken before treatment regardless of arm participants are assigned at baseline. It will be repeated 10 minutes after the each treatment
Time frame
Each in-person treatment event, total of 1 HR at arrival after being enrolled for baseline and then a repeat 10 minutes after treatment (regardless of which treatment arm); repeat sequence at the 2nd in-person visit for a total of 4 HR readingsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov