Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction

NCT05112887 | Completed

• 1 other identifier: 21-F-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to determine the efficacy of a treatment method that increase a participants sense of smell after suffering from COVID-19 related decline in smell. Participants have to be greater than 14 days from positive COVID-19 test and still have a decreased sense of smell. https://jaoa.org/article.aspx?articleid=2765119 this article is a review of literature regarding why OMT can have a positive effect on individuals suffering from COVID-19 Anosmia: Complete loss of smell Hyposmia: Decrease in smell

Conditions

COVID-19 Lower Respiratory Infection; SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (2)

• Smell Intensity

  Participants will smell the 4 substances blindfolded and will rank each one from 0-10, 0 being no smell and 10 be pre-COVID smell. Participant will then be treated either with OMT or placebo and then asked to resmell the same 4 smell substances and rank them on the same scale.

  10 minutes will elapse between treatment and post-treatment smell testing.

• Smell Identification

  Participants will smell the 4 substances blindfolded and attempt to identify the smells. Participants will then receive treatment either OMT or Placebo and will smell the same 4 substances while attempting to identify them again. Correct answers were given a score of "1" and incorrect answers were given a smell of "0"

  10 minutes will elapse between treatment and post-treatment smell testing.

Other Outcomes (1)

• Quantitative smell experience

  10 minutes will elapse between treatment and post-treatment smell testing.

Study Arms (2)

OMT Group

EXPERIMENTAL

The OMT protocol treatment sequence was performed in the following order: 1\. Rib raising from a seated position 2. Suboccipital Release from a supine position 3. Thoracic Inlet Release 4. Miller Lymphatic Pump 5. Pedal Pump 6. Suboccipital Release 7. Cranial Sinus Effleurage 1. Engaging the sagittal midline of occiput with pressure until release of the tissue is palpated 2. Direct pressure along the external region of the transverse sinus until release of the tissue is palpated. 3. Pressure on sagittal suture with transverse traction until release of the tissue is palpated 4. Pressure on metopic suture with transverse traction in a pulsatile manner 5. Vault hold 1\. Appreciate cranial respiratory motion 2. Diagnose cranial strain pattern 3. Place cranial strain pattern into position of ease

Other: Osteopathic Manipulative Therapy

Placebo/Light Touch/Sham Group

PLACEBO COMPARATOR

Participants in the sham/placebo group were lightly touched in equivalent positions to the OMT treatments. First, sham participants were lightly touched on the thoracic cage while seated, followed by light touch of the neck, chest, feet, and cranium while supine. The length of light touch was modeled after the approximate time needed for the OMT matching each treatment region. Each treatment sequence lasted about 20 minutes in total.

Other: Osteopathic Manipulative Therapy

Interventions

Osteopathic Manipulative Therapy OTHER

Osteopathic Manipulative Therapy is a type of hands-on manipulative medicine where the physician uses their hands and knowledge of anatomy to encourage the human body to reattain homeostasis.

Also known as: Osteopathic Manipulative Medicine

OMT Group; Placebo/Light Touch/Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Positive COVID test greater than 14 days prior
• Self-identify a decrease in smell after the resolution of their infection

You may not qualify if:

• Complete smell recovery after resolution of infection

Sponsors & Collaborators

• Ohio University: lead
• American Osteopathic Foundation: collaborator

Study Sites (1)

Ohio University Heritage College of Medicine - Dublin

Dublin, Ohio, 43016, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Steven Walkowski, DO

  Ohio University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Individual testing smell function was masked to whether participant was in treatment group or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will have to email a positive COVID-19 test result \>14 days prior to MS861918@ohio.edu. There will be a correspondence with the participant to ask them if they feel their sense is still decreased or absent and then candidacy for study will be determined. 20 participants will be divided randomly into sham OMT treatment groups and real OMT treatments. 10 in each group. Participants will rate on a scale of 0-10 (0 being no smell, and 10 being pre-COVID19 exposure smell) the ability to smell 4 items blindfolded pre-treatment as well as attempt to identify the substance

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 9, 2021
• Study Start: March 31, 2021
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-03

Locations

US (1)