Clinical trial NCT04764877: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Keywords: OMM
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 58
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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,)

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

Primary outcomes:
measure: Change in FEV1 on pre-therapy and post-therapy PFTs
timeFrame: 2 hours
measure: Change in FEF25-75 on pre-therapy and post-therapy PFTs
timeFrame: 2 hours
measure: Change in FVC on pre-therapy and post-therapy PFTs
timeFrame: 2 hours
measure: Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
timeFrame: 2 hours
Secondary outcomes:
measure: Standardized survey to look for adverse effects from the OMT
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References: