Recruiting

OMT

Sponsor:

Burrell College of Osteopathic Medicine

Code:

NCT06766279

Conditions

Anosmia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Osteopathic Manipulative Treatment

Sham treatment

Study Details

Brief summary:

One of the most widespread symptoms of COVID-19 is loss of the sense of smell. There are very few treatments for helping individuals recover their sense of smell. Osteopathic manipulative treatment (OMT) may be a useful tool in helping people recover their smell perception. In this study the investigators test whether OMT can be used to help individuals recover their sense of smell if they lost it during COVID-19.

Conditions

Anosmia

Study ID

NCT06766279

Start date

Aug 29, 2024

Status verified date

Jan, 2025

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Positive COVID-19 test or diagnoses
  • Self-reported deficiency in sense of smell

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy
  • Any findings on the osteopathic screening/evaluation that would hinder the effectiveness or increase the risk associated with OA decompression
  • Any medication that interferes with the sense of smell (intranasal zinc, intranasal antihistamines, intranasal corticosteroids)
  • Allergic rhinitis
  • Use of oral corticosteroids or antihistamines.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OMT

Subjects will undergo an evaluation of their sense of smell using a thoroughly-vetted and published protocol. If subjects are found to have a reduced sense of smell, they will be assigned to either the OMT or sham intervention. The OMT intervention will consist of two procedures: occipitoatlantal decompression and treating the nasal Chapman point. Subjects will then be evaluated after receiving treatment, as well as a follow-up visit the day after, and a final visit within 1-2 weeks post treatment.

sham comparator: Sham

Subjects will undergo an evaluation of their sense of smell using a thoroughly-vetted and published protocol. If subjects are found to have a reduced sense of smell, they will be assigned to either the OMT or sham intervention. The sham intervention will consist of the experimenter resting their hands on the sides of the subject's neck. Subjects will then be evaluated after receiving treatment, as well as a follow-up visit the day after, and a final visit within 1-2 weeks post treatment.

Interventions

Osteopathic Manipulative Treatment

The OMT intervention in this study will be comprised of an occipitoatlantal (OA) decompression and treatment of the nasal Chapman point. The OA decompression will be applied for 2 minutes with 12N of pressure as this pressure has been determined to produce the greatest effect. Treatment at this level reduces congestion of nasal mucosa. The suboccipital decompression technique is generally considered to bear minimal risks and is perceived by most patients as a pleasant experience. This technique is considered to be a basic skill among osteopathic physicians. It is usually taught within the first semester of the first year at Colleges of Osteopathic Medicine.

The other intervention technique will be addressing the nasal Chapman points that are found at the tip of the transverse process of C1 and the costochondral junction of the first rib on each side. Both techniques are performed while the subject is supine.

Sham treatment

The sham intervention will consist of the subject lying supine with the investigator's hands resting gently on both sides of subject's neck for 5 minutes.

Primary outcome measure

  • Ability to Recover Sense of Smell after OMT [ Time Frame: from enrollment until 2 weeks post treatment ]

Central Contacts and Locations

Central contacts

Locations

Burrell College of Osteopathic Medicine

Recruiting

Las Cruces, New Mexico, United States, 88001

Contacts

Thomas P Eiting, Ph.D

5756742245teiting@burrell.edu

More Information

Sponsor

Burrell College of Osteopathic Medicine

Last update posted

Jan 9, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Burrell College of Osteopathic Medicine on 2025-01-09.