Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma
NCT ID: NCT04764877
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2015-02-01
2019-12-31
Brief Summary
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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.
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Detailed Description
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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,)
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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
No interventions assigned to this group
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)
Osteopathic Manipulative Medicine
Provided 15-20 minute long OMT session for patients in the OMT arm
Interventions
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Osteopathic Manipulative Medicine
Provided 15-20 minute long OMT session for patients in the OMT arm
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of asthma
* Scheduled for routine asthma care at our clinic
* at least one prior PFT done prior to this visit
Exclusion Criteria
* 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
7 Years
18 Years
ALL
No
Sponsors
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Nationwide Children's Hospital
OTHER
Responsible Party
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Alex Rakowsky
Assistant Professor Primary Care Pediatrics/Associate Residency Program Director
Other Identifiers
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IRB #14-000667
Identifier Type: -
Identifier Source: org_study_id
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