Osteopathic Manipulative Treatment for Loss of Smell

Overseen By Adrienne Kania, D.O.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Burrell College of Osteopathic Medicine

Must not be taking: Intranasal zinc, intranasal antihistamines

Disqualifiers: Age under 18, pregnancy, allergic rhinitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether osteopathic manipulative treatment (OMT) can help individuals regain their sense of smell after losing it due to COVID-19. Participants will receive either OMT, which involves gentle adjustments to specific areas, or a sham treatment, a pretend version used for comparison. The trial targets those who tested positive for COVID-19 and have experienced a loss of smell. The goal is to determine if OMT can serve as a helpful treatment for this condition. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research on innovative treatments for COVID-19-related smell loss.

Will I have to stop taking my current medications?

If you are taking any medications that interfere with the sense of smell, such as intranasal zinc, intranasal antihistamines, intranasal corticosteroids, or oral corticosteroids or antihistamines, you will need to stop taking them to participate in the trial.

What prior data suggests that osteopathic manipulative treatment is safe for loss of smell?

Research has shown that Osteopathic Manipulative Treatment (OMT) is usually well-tolerated. In one study involving 22 people, all participants reported improvement in symptoms such as stuffy nose and sense of smell. Another study described four cases where individuals with long COVID experienced enhanced smell and taste after OMT. These findings suggest that OMT might be safe, with no major side effects reported. However, as with any treatment, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about osteopathic manipulative treatment (OMT) for loss of smell because it offers a hands-on approach that differs from typical medical or pharmacological interventions. Unlike standard treatments that might involve medications or olfactory training, OMT focuses on physical manipulation techniques such as occipitoatlantal decompression and treating the nasal Chapman point. These techniques aim to improve cranial and nasal function, potentially restoring the sense of smell more naturally and quickly. This unique method could provide a non-invasive alternative with immediate effects, appealing to those seeking solutions without relying on drugs.

What evidence suggests that osteopathic manipulative treatment is effective for loss of smell?

Studies have shown that osteopathic manipulative treatment (OMT) can alleviate conditions like sinusitis by reducing stuffiness and pain. Research suggests that OMT can enhance regular medical care by lessening symptoms. In this trial, participants will receive either the OMT or a sham intervention to evaluate its effectiveness for those who have lost their sense of smell due to upper respiratory infections, such as COVID-19. Early findings indicate that OMT might help restore their ability to smell. While specific data on smell recovery is still being gathered, some studies suggest OMT could be a promising option for those experiencing smell loss from COVID-19. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have lost their sense of smell due to COVID-19. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I have tested positive for COVID-19.

I have trouble smelling things.

Exclusion Criteria

I am currently taking oral corticosteroids or antihistamines.

My bone health evaluation shows risks for a specific arthritis treatment.

I am not using any nasal treatments that affect my sense of smell.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either the OMT intervention or sham treatment, followed by olfactory testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in olfactory acuity with daily testing for up to 10 days

10 days

Daily visits (in-person)

Final Assessment

Final evaluation of olfactory acuity 1-2 weeks post-treatment

1-2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment

Trial Overview

The trial is testing if Osteopathic Manipulative Treatment (OMT) can help people regain their sense of smell after COVID-19. Participants will be randomly assigned to receive either OMT or a sham treatment as a comparison.

How Is the Trial Designed?

Group I: OMT Experimental Treatment 1 Intervention

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.

Group II: Sham Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Burrell College of Osteopathic Medicine

Lead Sponsor

Trials

6

Recruited

330+

Published Research Related to This Trial

The Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR) is a newly developed and validated quality-of-life measure specifically for patients experiencing parosmia, demonstrating strong reliability and validity in a study involving 134 patients and 20 healthy controls.

DisODOR effectively distinguishes between patients with parosmia and healthy individuals, with a significant mean score difference of 45.0, and is sensitive to changes in patients' conditions, making it a useful tool for evaluating treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of the Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR). Ioerger, P., Kallogjeri, D., Roland, L., et al.[2023]

Olfactory dysfunction is linked to serious health issues, including neurodegeneration, and requires comprehensive assessment methods, such as rigid nasal endoscopy and validated psychophysical tests, to ensure accurate diagnosis and treatment.

Smell training has been identified as a beneficial intervention for patients experiencing olfactory loss, suggesting that structured rehabilitation can improve outcomes across various causes of smell impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position paper on olfactory dysfunction. Hummel, T., Whitcroft, KL., Andrews, P., et al.[2022]

Osteopathic manipulative treatment, specifically the Galbreath technique, can help alleviate otitis media by using mandibular manipulation to promote drainage of fluid from the ear.

This technique is simple enough for physicians to teach to parents, allowing them to perform it at home to assist in managing their child's ear condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Galbreath technique: a manipulative treatment for otitis media revisited. Pratt-Harrington, D.[2005]

Surgical and pharmaceutical treatments, particularly corticosteroids, have been shown to effectively manage olfactory disorders caused by sinonasal disease, highlighting their efficacy in improving patients' sense of smell.

For olfactory disorders resulting from trauma or viral infections, current treatment options are limited to non-pharmacological methods like olfactory training, indicating a gap in effective pharmacological interventions for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of olfactory disorders]. Hummel, T., Stuck, BA.[2021]

In a study of 60 patients with smell loss due to upper respiratory infections, verum acupuncture significantly improved olfactory function compared to sham acupuncture, as measured by the TDI score.

The improvement in smell function was primarily due to better odor discrimination, and was especially notable in patients who had experienced smell loss for a shorter duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture is associated with a positive effect on odour discrimination in patients with postinfectious smell loss-a controlled prospective study. Drews, T., Hummel, T., Rochlitzer, B., et al.[2022]

Cranial osteopathic manipulative medicine (OMM) shows potential benefits in reducing pain, improving sleep patterns, and enhancing autonomic nervous system function based on a review of 8 studies, including 7 randomized controlled trials.

However, the evidence is heterogeneous and of moderate quality, indicating that more rigorous research is necessary to establish definitive conclusions about the efficacy of cranial OMM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. Jäkel, A., von Hauenschild, P.[2022]

The Nasal Airflow-Inducing Manoeuvre (NAIM) showed effectiveness in improving olfactory function in patients who underwent laryngectomy, with all participants achieving normosmic status by the end of the study.

Early rehabilitation through structured NAIM training sessions, followed by reinforcement, has the potential to restore olfactory abilities to pre-operative levels, as indicated by both objective olfactory tests and patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of olfactory rehabilitation according to a structured protocol with potential of regaining pre-operative levels in laryngectomy patients using nasal airflow-inducing manoeuvre. Risberg-Berlin, B., Karlsson, TR., Tuomi, L., et al.[2021]

Osteopathic manipulative treatment (OMT) of the sphenopalatine ganglion (SPG) showed a significant improvement in pharyngeal stability for patients with obstructive sleep apnea, with 5 out of 7 patients responding positively after active manipulation compared to none after sham manipulation.

The study demonstrated the feasibility of a randomized, controlled, double-blind design for evaluating OMT, although it highlighted the need for larger studies to further assess its efficacy on the apnoea-hypopnoea index.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study. Jacq, O., Arnulf, I., Similowski, T., et al.[2018]

A systematic review of 12 studies involving 367 participants found moderate-quality evidence that osteopathic manipulative treatment (OMT) significantly reduces disability, severity, and frequency of dizziness associated with neuro-otologic disorders.

Despite the positive findings, the evidence should be interpreted cautiously due to high risk of bias and small sample sizes in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of osteopathic manipulative techniques on the management of dizziness caused by neuro-otologic disorders: systematic review and meta-analysis. Rehman, Y., Kirsch, J., Wang, MY., et al.[2023]

In a study involving 31 patients with obstructive sleep apnoea syndrome, manipulation of the sphenopalatine ganglia did not significantly reduce the apnoea-hypopnoea index, indicating it may not be an effective treatment for this condition.

However, the manipulation did lead to a significant increase in peak nasal inspiratory flow, suggesting it may help reduce nasal obstruction, although further research with a larger sample size is needed to confirm this effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulation of the Sphenopalatine Ganglia Versus Sham Manipulation, in Obstructive Sleep Apnoea Syndrom: A Randomised Controlled Trial. Attali, V., Jacq, O., Martin, K., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06766279

Investigating the Efficacy of OMT to Recover Olfactory ...

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. Detailed ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7516474/

Evidence-based assessment of potential therapeutic effects of ...

OMT can improve the condition of infected patients by decreasing symptoms and boosting the efficiency of conventional care.

3.

withpower.com

withpower.com/trial/phase-anosmia-7-2024-93833

Osteopathic Manipulative Treatment for Loss of Smell

In a study of 60 patients with smell loss due to upper respiratory infections, verum acupuncture significantly improved olfactory function compared to sham ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06883513/osteopathic-manipulative-therapy-effects-on-post-acute-sequelae-of-covid-19-pasc-or-long-covid

Osteopathic Manipulative Therapy Effects on Post-Acute ...

This study is investigating the effects of using an Osteopathic Manipulative Therapy (OMT) treatment protocol that was shown to statistically improve smell.

5.

acofp.org

acofp.org/docs/default-source/ofp/vol-14-no-2-(2022)-march-april-2022/osteopathic-manipulative-treatment-for-sinusitis-relief-a-pilot-study.pdf?sfvrsn=4eee9d0c_0

osteopathic-manipulative-treatment-for-sinusitis-relief-a- ...

Our study has shown that OMT results in symptomatic improvement of sinusitis by alleviating nasal congestion, postnasal drip, sinus pain, headache, loss of ...

6.

researchgate.net

researchgate.net/publication/376211915_Osteopathic_Manipulative_Treatment_to_Treat_Patients_with_Long-Haul_COVID_Loss_of_Smell_and_Taste_A_Report_of_Four_Cases

Osteopathic Manipulative Treatment to Treat Patients with ...

Four cases of patients with Long COVID symptoms of loss of the sense of smell and sense of taste are presented. They differ from the findings in the ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12302173/

COVID-19 mRNA vaccine immune response to the addition ...

Osteopathic manipulative treatment (OMT) has demonstrated immune ... loss of taste and smell. When analyzing breakthrough infections ...