NCT06766279 · Burrell College of Health Sciences
Investigating the Efficacy of OMT to Recover Olfactory Perception After COVID-19
What this study is about
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.
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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.
Interventions
PROCEDURE
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.
PROCEDURE
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 measures
Ability to Recover Sense of Smell after OMT
Time frame: from enrollment until 2 weeks post treatment
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Positive COVID-19 test or diagnoses
- Self-reported deficiency in sense of smell
Exclusion criteria
- Age under 18 years
- 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.
Where
- Las Cruces, New Mexico
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2025 · Source of record for eligibility and locations