Asthma in Children
Conditions
Keywords
OMM
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,)
Interventions
Provided 15-20 minute long OMT session for patients in the OMT arm
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Standardized survey to look for adverse effects from the OMT | 2 hours | Standard form asking about common AEs seen with OMT |
Outcome results
None listed