Asthma and Osteopathic Manipulative Technique

NCT07071194 | Withdrawn

• 1 other identifier: STUDY20250241
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a common respiratory condition that can be difficult to control despite the use of medications such as inhalers, oral steroids or even injectable medications. Osteopathic Manipulative Treatment (OMT) is a hands-on technique used to improve the chest structure and function and may help in improving breathing. Previous research showed that OMT in asthma patients, can improve the movement of the ribs and improve the "peak flow" which is the maximum rate at which a person can exhale air after taking a deep breath. However, no studies have evaluated the impact of OMT on lung inflammation. This single-site research study at University Hospitals aims to evaluate whether Osteopathic Manipulative Treatment (OMT) can reduce lung inflammation and improve breathing and lung function in adult patients with asthma. The lung function will be evaluated by Spirometry which is a test that measures how much air you can breathe in and out of your lungs, as well as how quickly and easily you can exhale air. The lung inflammation will be measured using a device that can detect how much you are breathing out Nitric Oxide which is a gas produced by inflamed cells in the lungs, this test is called: Fractional exhaled Nitric Oxide or FeNO. Approximately 100 participants will be enrolled.

Conditions

Asthma

Keywords

Osteopathic Manipulative Treatment; Lung inflammation; Improved breathing

Outcome Measures

Primary Outcomes (2)

• Change in Fractionated Exhaled Nitric Oxide (FeNO) values as measured by NIOX FeNO device

  Baseline, after OMT treatment (up to 30 minutes), day 10

• Change in Peak Expiratory Flow values as measured by EasyOne Air Spirometer device

  Baseline, after OMT treatment (up to 30 minutes), day 10

Secondary Outcomes (3)

• Change in Ease of breathing as measured by Post-OMT Questionnaire

  Baseline and day 10

• Change in Rib Cage mobility as measured by Post-OMT Questionnaire

  Baseline and day 10

• Change in chest tightness as measured by Post-OMT Questionnaire

  Baseline and day 10

Study Arms (2)

Treatment group using OMT

EXPERIMENTAL

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

Procedure: OMT

Control group

ACTIVE COMPARATOR

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

Other: Light touch

Interventions

OMT PROCEDURE

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

Treatment group using OMT

Light touch OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients in Allergy and Immunology Associates clinic diagnosed with asthma ages 18-60 years old with an elevated FENO

You may not qualify if:

• Use of oral steroids within the last 4 weeks
• Use of biologic medications
• Diagnosis of pregnancy, osteoporosis, congestive heart failure, renal failure, cirrhosis, or cancer
• Inability to lay recumbent

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Allergy Immunology Associates

Mayfield Heights, Ohio, 44124, United States

Location

MeSH Terms

Conditions

Asthma; Pneumonia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Study Officials

• Nancy Wasserbauer-Kingston, DO

  University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)