Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma

Study Overview
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Brief Summary
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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
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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,)

Official Title
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Effect of Osteopathic Manipulation Therapy on Pulmonary Function Testing in Children With Asthma

Conditions
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Asthma in Children

Intervention / Treatment
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* Other: Osteopathic Manipulative Medicine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>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 | |
| Experimental: OMT arm<br>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) | Other: Osteopathic Manipulative Medicine<br>* Provided 15-20 minute long OMT session for patients in the OMT arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 on pre-therapy and post-therapy PFTs | FEV1 improvement | 2 hours | 
| Change in FEF25-75 on pre-therapy and post-therapy PFTs | FEV25-75 improvement | 2 hours | 
| Change in FVC on pre-therapy and post-therapy PFTs | FVC improvement | 2 hours | 
| Change in FVC/FEV1 on pre-therapy and post-therapy PFTs | Improvement in ratio | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized survey to look for adverse effects from the OMT | Standard form asking about common AEs seen with OMT | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OMM