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

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764877
• Other study ID #: IRB #14-000667
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• Osteopathic Manipulative Medicine
Provided 15-20 minute long OMT session for patients in the OMT arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1 on pre-therapy and post-therapy PFTs	FEV1 improvement	2 hours
Primary	Change in FEF25-75 on pre-therapy and post-therapy PFTs	FEV25-75 improvement	2 hours
Primary	Change in FVC on pre-therapy and post-therapy PFTs	FVC improvement	2 hours
Primary	Change in FVC/FEV1 on pre-therapy and post-therapy PFTs	Improvement in ratio	2 hours
Secondary	Standardized survey to look for adverse effects from the OMT	Standard form asking about common AEs seen with OMT	2 hours