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临床试验/NCT07071194
NCT07071194撤回不适用

The Effect of Osteopathic Manipulative Treatment on Respiratory Function in Patients With Asthma

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
100
试验地点
1
主要终点
Change in Fractionated Exhaled Nitric Oxide (FeNO) values as measured by NIOX FeNO device

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: OMT (Procedure)

Control group

Active Comparator

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

干预措施: Light touch (Other)

结局指标

主要结局

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

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

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

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

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Nancy Wasserbauer-Kingston

Physician

University Hospitals Cleveland Medical Center

研究点 (1)

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