Investigating the Efficacy of OMT to Recover Olfactory Perception After COVID-19
ConditionAnosmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBurrell College of Osteopathic Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Positive COVID-19 test or diagnoses
Self-reported deficiency in sense of smell
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Osteopathic Manipulative Treatment
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: OMTExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
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).
Time frame
from enrollment until 2 weeks post treatmentSponsors and contacts
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Source ClinicalTrials.gov