Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764877
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-01-21
Brief Title:
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 FVCFEV1 and FEF 25-75 were then compared
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 FVCFEV1 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 FVCFEV1 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
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 FVCFEV1 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None