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

Nationwide Children's Hospital

Status: Completed

Conditions: Asthma in Children

Treatments: Other: Osteopathic Manipulative Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04764877

IRB #14-000667

Details and patient eligibility

About

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.

Full 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,)

Enrollment: 58 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Standard Care

No Intervention group

Description:

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

OMT arm

Experimental group

Description:

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)

Treatment:

Other: Osteopathic Manipulative Medicine