Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
- Conditions
- Asthma in Children
- Interventions
- Other: Osteopathic Manipulative Medicine
- Registration Number
- NCT04764877
- Lead Sponsor
- Nationwide Children's Hospital
- Brief Summary
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.
- Detailed Description
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,)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description OMT arm Osteopathic Manipulative Medicine 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)
- Primary Outcome Measures
Name Time Method Change in FEV1 on pre-therapy and post-therapy PFTs 2 hours FEV1 improvement
Change in FEF25-75 on pre-therapy and post-therapy PFTs 2 hours FEV25-75 improvement
Change in FVC on pre-therapy and post-therapy PFTs 2 hours FVC improvement
Change in FVC/FEV1 on pre-therapy and post-therapy PFTs 2 hours Improvement in ratio
- Secondary Outcome Measures
Name Time Method Standardized survey to look for adverse effects from the OMT 2 hours Standard form asking about common AEs seen with OMT