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

NCT06883513 | Recruiting

• 1 other identifier: IRB Number: 23.0718
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Does this OMT protocol improve other non-smell related Long-COVID symptoms
2. 2.Do 2 OMT treatments improve Long-COVID symptoms more than 1 OMT treatment
3. 3.Week 1: Take an digital survey regarding their Long-COVID symptoms undergo Long-COVID OMT treatment or a placebo treatment
4. 4.Week 2: Take an digital survey regarding their Long-COVID symptoms then all will undergo Long-COVID OMT treatment
5. 5.Week 3: Take an digital survey regarding their Long-COVID symptoms
6. 6.Week 8: Take an digital survey regarding their Long-COVID symptoms

Conditions

Long-COVID; PASC; Long COVID Syndrome

Keywords

Long-COVID; PASC

Outcome Measures

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

  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

Secondary Outcomes (2)

• Blood Pressure(BP)

  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 readings

• Heart Rate (HR)

  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 readings

Study Arms (2)

OMT treatment

EXPERIMENTAL

Participants will undergo OMT protocol that has been shown to improve Long-COVID smell intensity

Other: Osteopathic Manipulative Therapy Long-COVID protocol; Other: Osteopathic Manipulative Therapy NOT Long-COVID treatment protocol

OMT sham

SHAM COMPARATOR

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".

Other: Osteopathic Manipulative Therapy NOT Long-COVID treatment protocol

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

Also known as: Osteopathic Manipulative Medicine

OMT treatment

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

OMT sham; OMT treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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):
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Outpatient Care Center

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (7)

• Hughes SE, Haroon S, Subramanian A, McMullan C, Aiyegbusi OL, Turner GM, Jackson L, Davies EH, Frost C, McNamara G, Price G, Matthews K, Camaradou J, Ormerod J, Walker A, Calvert MJ. Development and validation of the symptom burden questionnaire for long covid (SBQ-LC): Rasch analysis. BMJ. 2022 Apr 27;377:e070230. doi: 10.1136/bmj-2022-070230.

  PMID: 35477524 BACKGROUND

• Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005 Oct;105(10):447-56.

  PMID: 16314677 BACKGROUND

• Bryche B, St Albin A, Murri S, Lacote S, Pulido C, Ar Gouilh M, Lesellier S, Servat A, Wasniewski M, Picard-Meyer E, Monchatre-Leroy E, Volmer R, Rampin O, Le Goffic R, Marianneau P, Meunier N. Massive transient damage of the olfactory epithelium associated with infection of sustentacular cells by SARS-CoV-2 in golden Syrian hamsters. Brain Behav Immun. 2020 Oct;89:579-586. doi: 10.1016/j.bbi.2020.06.032. Epub 2020 Jul 3.

  PMID: 32629042 BACKGROUND

• Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, Dequanter D, Blecic S, El Afia F, Distinguin L, Chekkoury-Idrissi Y, Hans S, Delgado IL, Calvo-Henriquez C, Lavigne P, Falanga C, Barillari MR, Cammaroto G, Khalife M, Leich P, Souchay C, Rossi C, Journe F, Hsieh J, Edjlali M, Carlier R, Ris L, Lovato A, De Filippis C, Coppee F, Fakhry N, Ayad T, Saussez S. Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of the coronavirus disease (COVID-19): a multicenter European study. Eur Arch Otorhinolaryngol. 2020 Aug;277(8):2251-2261. doi: 10.1007/s00405-020-05965-1. Epub 2020 Apr 6.

  PMID: 32253535 BACKGROUND

• Butowt R, von Bartheld CS. Anosmia in COVID-19: Underlying Mechanisms and Assessment of an Olfactory Route to Brain Infection. Neuroscientist. 2021 Dec;27(6):582-603. doi: 10.1177/1073858420956905. Epub 2020 Sep 11.

  PMID: 32914699 BACKGROUND

• Gengler I, Wang JC, Speth MM, Sedaghat AR. Sinonasal pathophysiology of SARS-CoV-2 and COVID-19: A systematic review of the current evidence. Laryngoscope Investig Otolaryngol. 2020 Apr 16;5(3):354-359. doi: 10.1002/lio2.384. eCollection 2020 Jun.

  PMID: 32587887 BACKGROUND

• Mollica V, Rizzo A, Massari F. The pivotal role of TMPRSS2 in coronavirus disease 2019 and prostate cancer. Future Oncol. 2020 Sep;16(27):2029-2033. doi: 10.2217/fon-2020-0571. Epub 2020 Jul 13. No abstract available.

  PMID: 32658591 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Darryl Kaelin, MD, Medical Doctorate (US)

  University of Louisville School of Medicine Chair of PM&R Division of the Department of Neurological Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael E Stenta, DO, Doctor of Osteopathic Medicine

CONTACT

15137289344; michael.stenta@uoflhealth.org

Rebecca Lynn, DO, Doctor of Osteopathic Medicine

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: May 1, 2025
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)