Asthma and Osteopathic Manipulative Technique

Not Applicable

Not yet recruiting

• Conditions: Asthma

• Registration Number: NCT07071194
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-19
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Study Start: 2025-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Ease of breathing as measured by Post-OMT Questionnaire	Baseline and day 10	The post_OMT Questionnaire scores ease of breathing on a Likert scale of 1-0 with 1 being difficult to breathe and 10 being easy to breath
Change in Rib Cage mobility as measured by Post-OMT Questionnaire	Baseline and day 10	The post_OMT Questionnaire scores Rib Cage mobility on a Likert scale of 1-0 with 1 being stiff and 10 being mobile
Change in chest tightness as measured by Post-OMT Questionnaire	Baseline and day 10	The post_OMT Questionnaire scores chest tightness on a Likert scale of 1-0 with 1 being tight and 10 being loose

Trial Locations

Locations (1)

Allergy Immunology Associates; 🇺🇸 Mayfield Heights, Ohio, United States