Asthma and Osteopathic Manipulative Technique

NCT ID: NCT07071194

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group using OMT

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

Group Type: EXPERIMENTAL

OMT

Intervention Type: PROCEDURE

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

Control group

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

Group Type: ACTIVE_COMPARATOR

Light touch

Intervention Type: OTHER

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

Interventions

OMT

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

Intervention Type: PROCEDURE

Light touch

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Nancy Wasserbauer-Kingston

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Wasserbauer-Kingston, DO

Role: PRINCIPAL_INVESTIGATOR

University Hospitals

Locations

Allergy Immunology Associates

Mayfield Heights, Ohio, United States

Countries

United States

Central Contacts

Remie Saab, MD

Role: CONTACT

remie.saab@Uhhospitals.org

(216) 381-3333

Facility Contacts

Remie Saab, MD

Role: primary

remie.saab@Uhhospitals.org

(216) 381-3333

Other Identifiers

STUDY20250241

Identifier Type: -

Identifier Source: org_study_id