Efficacy and Safety of Osteopathic Manipulative Treatment on Asthmatics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Asthma Control Test (ACT) Score
研究概览
简要总结
This is a pilot study in which the objective is to determine the feasibility of a randomized clinical trial investigating the safety and efficacy of OMT as an adjunctive treatment for patients with mild to moderate asthma compared to the same patient population without the use of OMT. OMT may be able to correct anatomical dysfunctions that contribute to increased symptoms in asthmatic patients. OMT's effect on asthma will be demonstrated by symptomatology reporting, frequency of medication use, and pulmonary function tests.
详细描述
Asthma is a leading cause of activity limitation and healthcare burden in the United States of America. The asthmatic population is in need of treatments that target reducing asthma symptoms, reduce the need for medication, and improve lung functionality. As of today, there are not many studies investigating the efficacy and safety of osteopathic manipulative treatment (OMT) on asthmatic patients. This is a pilot study in which the objective is to determine the feasibility of a randomized clinical trial investigating the safety and efficacy of OMT as an adjunctive treatment for patients with mild to moderate asthma compared to the same patient population without the use of OMT. Subjects will be randomized into either a control group or an intervention group where OMT will be used in conjunction with standard asthmatic treatment. Subjective and objective measurements will be taken including the Asthma Control Test (ACT) questionnaire, peak flow, spirometry, pulse oximetry, and chest/diaphragmatic excursion measurements. Measurements will be compared from baseline, before the first treatment and at the follow-up visit after the final treatment.
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
- Double (Care Provider, Investigator)
盲法说明
Care providers were not involved in any data analysis and the investigator was also blind to the assignment and outcomes assessment.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with mild to moderate asthma (Episodic symptoms included were airflow obstruction or airway hyper-responsiveness, and airflow obstruction that was at least partially reversible (based upon an increase in FEV1 or greater than or equal to 12% from baseline or by an increase of at least 10% of predicted FEV1 after inhalation of a short-acting bronchodilator)
排除标准
- •pneumonia
- •COPD as a primary diagnosis
- •pulmonary fibrosis
- •smoking history
- •inability to perform pulmonary function tests
- •history of recent myocardial infarction or heart disease
- •unable to respond to the questionnaire
- •unable to provide informed consent
- •using muscle relaxants
- •Any contraindications to OMT such as: known bone metastases, severe osteoporosis, osteomyelitis, or fracture
结局指标
主要结局
Asthma Control Test (ACT) Score
时间窗: Between baseline and 5 weeks
Determine the efficacy of adjunctive OMT treatment when compared to standard care in the reduction of symptomatology of dyspnea, wheezing and bronchoconstriction and decrease medication use as measured by the Expert Panel Report 3 and Global Initiative for Asthma Monitoring Asthma Control Test (ACT) questionnaire which is scored on a range from 5 to 25 with higher scores indicating better control of asthma symptoms.
次要结局
- Pulse Oximetry (Blood O2 Saturation Levels)(Between baseline and 5 weeks)
- Morphological Measurements of Chest and Diaphragm Excursion(Between baseline and 5 weeks)
- Pulse Oximetry (Pulse Rate)(Between baseline and 5 weeks)
- Spirometry Readings: Forced Expiratory Volume in One Second (FEV1)(Between baseline and 5 weeks)
研究者
Jesus Sanchez
Assistant Dean of Academic Affairs, Professor of NMM/OMM & Family Medicine
Western University of Health Sciences