Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
Primary Purpose
Asthma in Children
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteopathic Manipulative Medicine
Sponsored by
About this trial
This is an interventional treatment trial for Asthma in Children focused on measuring OMM
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
OMT arm
Arm Description
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
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)
Outcomes
Primary Outcome Measures
Change in FEV1 on pre-therapy and post-therapy PFTs
FEV1 improvement
Change in FEF25-75 on pre-therapy and post-therapy PFTs
FEV25-75 improvement
Change in FVC on pre-therapy and post-therapy PFTs
FVC improvement
Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
Improvement in ratio
Secondary Outcome Measures
Standardized survey to look for adverse effects from the OMT
Standard form asking about common AEs seen with OMT
Full Information
NCT ID
NCT04764877
First Posted
January 21, 2021
Last Updated
February 18, 2021
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04764877
Brief Title
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
Official Title
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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,)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
OMM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Patients were randomized to either standard of care/teaching at our Hilltop Primary Care Center Asthma clinic OR to standard of care/teaching PLUS one time osteopathic manipulation focusing on improving lung expansion.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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
Arm Title
OMT arm
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Medicine
Intervention Description
Provided 15-20 minute long OMT session for patients in the OMT arm
Primary Outcome Measure Information:
Title
Change in FEV1 on pre-therapy and post-therapy PFTs
Description
FEV1 improvement
Time Frame
2 hours
Title
Change in FEF25-75 on pre-therapy and post-therapy PFTs
Description
FEV25-75 improvement
Time Frame
2 hours
Title
Change in FVC on pre-therapy and post-therapy PFTs
Description
FVC improvement
Time Frame
2 hours
Title
Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
Description
Improvement in ratio
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Standardized survey to look for adverse effects from the OMT
Description
Standard form asking about common AEs seen with OMT
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study is completed and pending publication in the Journal of Osteopathic Medicine (formerly JAOA) Once published we do plan to share data with those interested
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
From interested OMT researchers
Learn more about this trial
Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
We'll reach out to this number within 24 hrs