The Effect of Osteopathic Manipulative Treatment on Respiratory Function in Patients With Asthma
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
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
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
Nancy Wasserbauer-Kingston
Physician
University Hospitals Cleveland Medical Center
