Osteopathic Manipulative Treatment for Asthma

Overseen By Remie Saab, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Oral steroids, Biologics

Disqualifiers: Pregnancy, Osteoporosis, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a hands-on technique called Osteopathic Manipulative Treatment (OMT) can help people with asthma breathe better by reducing lung inflammation. Researchers will test participants' lung function to assess exhalation and measure inflammation levels through a simple breath test. The study seeks adults with asthma who frequently experience breathing issues and show signs of lung inflammation. As an unphased trial, it offers participants the opportunity to contribute to innovative research that may improve asthma management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used oral steroids in the last 4 weeks or are using biologic medications.

What prior data suggests that Osteopathic Manipulative Treatment is safe for asthma patients?

Research has shown that Osteopathic Manipulative Treatment (OMT) is generally safe and well-tolerated. Studies have found no serious side effects linked to OMT. Mild side effects were rare and occurred at similar rates in both those who received OMT and those who did not. For example, studies involving OMT reported about one mild side effect per person, mostly minor. This suggests that OMT is a safe option for individuals considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manipulative Treatment (OMT) for asthma because it takes a hands-on, holistic approach that differs from traditional asthma treatments like inhalers and corticosteroids. Unlike these standard options that focus on controlling inflammation and opening airways with medication, OMT uses techniques like sub-occipital release and rib raising to potentially improve respiratory function and reduce symptoms through physical manipulation. This non-drug approach could offer a complementary or alternative method for managing asthma without the side effects associated with long-term medication use.

What evidence suggests that Osteopathic Manipulative Treatment is effective for asthma?

Research has shown that Osteopathic Manipulative Treatment (OMT), which participants in this trial may receive, can help people with asthma breathe better. It achieves this by enhancing rib movement and improving peak flow, which measures how fast air can be expelled. Some studies have found that while OMT might not improve all aspects of lung health, it can positively affect peak expiratory flow (PEF). Additionally, OMT can help manage asthma by reducing anxiety related to breathing problems. This hands-on technique might offer a safe and non-invasive way to improve overall breathing. These findings suggest OMT could be a helpful addition to asthma care. ^{1 2 5 6 7}

Who Is on the Research Team?

Nancy Wasserbauer-Kingston, DO

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

This trial is for adult asthma patients who may benefit from a hands-on technique called Osteopathic Manipulative Treatment (OMT). Participants should be able to perform lung function tests. Specific inclusion and exclusion criteria details are not provided, but typically these would outline health conditions or factors that qualify or disqualify someone from participating.

Inclusion Criteria

I am 18-60 years old, have asthma, and an elevated FENO level.

Exclusion Criteria

I am taking biologic medications.

I have not taken oral steroids in the last 4 weeks.

I have been diagnosed with pregnancy, osteoporosis, heart failure, kidney failure, cirrhosis, or cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Osteopathic Manipulative Treatment (OMT) or light touch control over a period of 10 days

2 weeks

Multiple visits for OMT sessions

Follow-up

Participants are monitored for changes in lung function and inflammation after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Technique

Trial Overview

The study is testing if OMT can reduce lung inflammation and improve breathing in asthma patients. It compares the effects of OMT against light touch (a control intervention) on lung function measured by Spirometry and FeNO, which assesses air flow and inflammation.

How Is the Trial Designed?

Group I: Treatment group using OMT Experimental Treatment 1 Intervention

Patients in the treatment group will undergo OMT using sub-occipital release, rib raising, doming the diaphragm, thoracic inlet release and myofascial techniques.

Group II: Control group Active Control 1 Intervention

Patients in the control group will undergo light touch in similar locations to above performed OMT.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03864354

Asthma and Osteopathic Manipulative Treatment

The effect of Osteopathic Manipulative Treatment (OMT) has been studied in adult patients with chronic obstructive pulmonary disease (COPD) and children ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7326176/

Short-term effect of osteopathic manual techniques (OMT) ...

Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1360859225000993

An overview of systematic reviews on the efficacy and ...

The summarized results of the reviews show that OMT and CST are effective in reducing pain, reducing functional impairment and improving quality of life in ...

4.

degruyterbrill.com

degruyterbrill.com/document/doi/10.7556/jaoa.2020.121/html?lang=en&srsltid=AfmBOorkHDLuZX-6toaW2tCNG7xwdc7vL_DiC-dZygyYLOK0896CCxWW

An Osteopathic Modular Approach to Asthma: A Narrative ...

Regardless, OMT intervention has been beneficial for asthma management by decreasing anxiety resulting from respiratory distress and improving ...

5.

acofp.org

acofp.org/news-and-publications/journal/article-detail/vol-12-no-6-(2020)-november-december-2020/osteopathic-manipulative-treatments-pediatric-conditions

Osteopathic Manipulative Treatments for Pediatric Conditions

The use of OMT, as a safe and non-invasive treatment, could help to provide a comprehensive treatment protocol for pediatric asthma patients by addressing this ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9021775/

Efficacy and safety of osteopathic manipulative treatment

To summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions.

7.

bmccomplementmedtherapies.biomedcentral.com

bmccomplementmedtherapies.biomedcentral.com/articles/10.1186/s12906-023-04230-2

Defining the landscape of patient harm after osteopathic ...

During the first nine days after OMT, AEs were observed to be mild in the majority of cases. The incidence rate was benchmarked at 1.0 AEs per ...