Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Change in FEV1 on pre-therapy and post-therapy PFTs
研究概览
简要总结
Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.
Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.
详细描述
Objective To evaluate change in same-day pulmonary function testing in pediatric patients receiving OMT compared to those receiving usual care.
Methods For this study, we selected patients utilizing the following inclusion criteria: 1) ages 7-18 years, 2) a diagnosis of asthma, 3) patients receiving care at a primary care-based asthma clinic, and 4) those patients who had baseline spirometry. Selected patients were then randomized to either an OMT or a control group. We excluded patients who were experiencing an acute asthma exacerbation. Patients in the OMT group were treated with rib raising and suboccipital release, in addition to standard asthma care, while control group patients received standard care only. A second PFT was performed on both groups at the end of the visit. OMT was performed by multiple osteopathic pediatric residents who were specifically trained for the purposes of this study. Change in spirometry results (FVC, FEV1, FVC/FEV1, and FEF 25-75%) were then compared.
NOTE: The OMTs were done either by our OMM attending at that time (Dr. Wolf) or by residents trained by her for this study (Drs. Jones, Pe, Bryant and Regan,)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age as noted above
- •Diagnosis of asthma
- •Scheduled for routine asthma care at our clinic
- •at least one prior PFT done prior to this visit
排除标准
- •Clinical indication for pre- and post-bronchodilator spirometry on day of visit
- •albuterol use w/in 8 hours of the visit
- •oral steroid use in previous 2 weeks
- •diagnosis of asthma exacerbation w/in prior 4 weeks
研究组 & 干预措施
Standard Care
Standard teaching and physical exam for any patient that would be seen at our Hilltop Primary Care center asthma clinic. This included baseline PFTs. FOR THIS STUDY a second set of PFTs were obtained at the end of the visit
OMT arm
As above BUT with the addition of standardized OMT focusing on lung functionality. OMT provided by either our OMM attending at that time (Dr Wolf) or residents trained by her for this study (Drs. Regan, Jones, Pe and Bryant)
干预措施: Osteopathic Manipulative Medicine (Other)
结局指标
主要结局
Change in FEV1 on pre-therapy and post-therapy PFTs
时间窗: 2 hours
FEV1 improvement
Change in FEF25-75 on pre-therapy and post-therapy PFTs
时间窗: 2 hours
FEV25-75 improvement
Change in FVC on pre-therapy and post-therapy PFTs
时间窗: 2 hours
FVC improvement
Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
时间窗: 2 hours
Improvement in ratio
次要结局
- Standardized survey to look for adverse effects from the OMT(2 hours)
研究者
Alex Rakowsky
Assistant Professor Primary Care Pediatrics/Associate Residency Program Director
Nationwide Children's Hospital