Investigating the Efficacy of OMT to Recover Olfactory Perception After COVID-19

NCT06766279 | Recruiting

• 1 other identifier: 0118_2023
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Ability to Recover Sense of Smell after OMT

  Data from 32 COVID-19-positive individuals will be collected. This group will be divided into 2 groups of 16: one of these groups will be given the OMT intervention, and one will be given a sham intervention. The sample size of 16 per group comes about as follows. The main dependent variable measured for each person will be the number of odors identified out of a panel of 16 odors. This will be in the form of a multiple-forced-choice questionnaire: participants will be required to identify the odor from a selection of possible options. Upon treatment and re-testing, we will measure the number of odors identified again. Previous work (Whitcroft et al. 2016, Rhinology 54:368-373) that has looked at the effects of sodium citrate treatment on odor identification ability has shown a mean improvement of just over 2 points using this same identification test (for example, subjects able to correctly identify 14 odors posttreatment and just 12 odors pre-treatment).

  from enrollment until 2 weeks post treatment

Study Arms (2)

OMT

EXPERIMENTAL

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.

Procedure: Osteopathic Manipulative Treatment

Sham

SHAM COMPARATOR

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.

Procedure: Sham treatment

Interventions

Osteopathic Manipulative Treatment PROCEDURE

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.

OMT

Sham treatment PROCEDURE

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.

Sham

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burrell College of Osteopathic Medicine: lead

Study Sites (1)

Burrell College of Osteopathic Medicine

Las Cruces, New Mexico, 88001, United States

RECRUITING

Related Publications (11)

• Degenhardt BF, Johnson JC, Brooks WJ, Norman L. Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. J Am Osteopath Assoc. 2018 Mar 1;118(3):141-149. doi: 10.7556/jaoa.2018.033.

  PMID: 29480914 BACKGROUND

• Kania AM, Weiler KN, Kurian AP, Opena ML, Orellana JN, Stauss HM. Activation of the cholinergic antiinflammatory reflex by occipitoatlantal decompression and transcutaneous auricular vagus nerve stimulation. J Osteopath Med. 2021 Feb 24;121(4):401-415. doi: 10.1515/jom-2020-0071.

  PMID: 33694358 BACKGROUND

• Hummel T, Sekinger B, Wolf SR, Pauli E, Kobal G. 'Sniffin' sticks': olfactory performance assessed by the combined testing of odor identification, odor discrimination and olfactory threshold. Chem Senses. 1997 Feb;22(1):39-52. doi: 10.1093/chemse/22.1.39.

  PMID: 9056084 BACKGROUND

• 8. Dostálová N. 2022. Effect of Osteopathic treatment on the post-covid loss of smell and taste. Thesis for Master of Science in Osteopathy, London College of Osteopathy and Health Sciences

  BACKGROUND

• Jacob B, Sawhney M, Sridhar A, Jacob B, Muller J, Abu-Sbaih R, Yao SC. Potential therapeutic effects of adjunct osteopathic manipulative treatments in SARS-CoV-2 patients. J Osteopath Med. 2023 Apr 21;123(7):343-349. doi: 10.1515/jom-2022-0207. eCollection 2023 Jul 1.

  PMID: 37079451 BACKGROUND

• Moon HS, Chon JY, Lee SH, Ju YM, Sung CH. Long-term Results of Stellate Ganglion Block in Patients with Olfactory Dysfunction. Korean J Pain. 2013 Jan;26(1):57-61. doi: 10.3344/kjp.2013.26.1.57. Epub 2013 Jan 4.

  PMID: 23342209 BACKGROUND

• Nguyen TP, Patel ZM. Budesonide irrigation with olfactory training improves outcomes compared with olfactory training alone in patients with olfactory loss. Int Forum Allergy Rhinol. 2018 Sep;8(9):977-981. doi: 10.1002/alr.22140. Epub 2018 Jun 14.

  PMID: 29901865 BACKGROUND

• Sun GH, Raji CA, Maceachern MP, Burke JF. Olfactory identification testing as a predictor of the development of Alzheimer's dementia: a systematic review. Laryngoscope. 2012 Jul;122(7):1455-62. doi: 10.1002/lary.23365. Epub 2012 May 2.

  PMID: 22552846 BACKGROUND

• Domellof ME, Lundin KF, Edstrom M, Forsgren L. Olfactory dysfunction and dementia in newly diagnosed patients with Parkinson's disease. Parkinsonism Relat Disord. 2017 May;38:41-47. doi: 10.1016/j.parkreldis.2017.02.017. Epub 2017 Feb 21.

  PMID: 28242255 BACKGROUND

• Cooper KW, Brann DH, Farruggia MC, Bhutani S, Pellegrino R, Tsukahara T, Weinreb C, Joseph PV, Larson ED, Parma V, Albers MW, Barlow LA, Datta SR, Di Pizio A. COVID-19 and the Chemical Senses: Supporting Players Take Center Stage. Neuron. 2020 Jul 22;107(2):219-233. doi: 10.1016/j.neuron.2020.06.032. Epub 2020 Jul 1.

  PMID: 32640192 BACKGROUND

• Whitcroft KL, Hummel T. Olfactory Dysfunction in COVID-19: Diagnosis and Management. JAMA. 2020 Jun 23;323(24):2512-2514. doi: 10.1001/jama.2020.8391. No abstract available.

  PMID: 32432682 BACKGROUND

Related Links

• COVID isolating

MeSH Terms

Conditions

Anosmia

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Thomas P Eiting, Ph.D

CONTACT

575-674-2245; teiting@burrell.edu

Adrienne Kania, D.O.

CONTACT

575-674-2355; akania@burrell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiology

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: August 29, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)