Osteopathic Manipulative Treatment for Loss of Smell

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Osteopathic Manipulative Treatment for loss of smell?

While there is no direct evidence for Osteopathic Manipulative Treatment in improving smell loss, similar non-drug therapies like olfactory training have shown potential benefits for smell recovery in various conditions. ^{1 2 3 4 5}

How does osteopathic manipulative treatment differ from other treatments for loss of smell?

Osteopathic manipulative treatment (OMT) is unique because it involves hands-on techniques to improve body function by manipulating the body's structure, such as the primary respiratory mechanism, which is different from standard medical treatments that might focus on medications or surgery. This approach is novel for loss of smell as it aims to enhance structural and functional balance, potentially addressing underlying issues that affect the sense of smell. ^{6 7 8 9 10}

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Osteopathic Manipulative Treatment (Other)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Germany 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Development and Validation of the Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR). [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Position paper on olfactory dysfunction. [2022]

4. Germany 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. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of olfactory disorders]. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulation of the Sphenopalatine Ganglia Versus Sham Manipulation, in Obstructive Sleep Apnoea Syndrom: A Randomised Controlled Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Galbreath technique: a manipulative treatment for otitis media revisited. [2005]

8. England 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. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. [2022]

10. Germany 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. [2023]