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

NCT04764877 | Completed

• 1 other identifier: IRB #14-000667
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma in Children

Keywords

OMM

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Standardized survey to look for adverse effects from the OMT

  2 hours

Study Arms (2)

Standard Care

NO INTERVENTION

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

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

Interventions

Osteopathic Manipulative Medicine OTHER

Provided 15-20 minute long OMT session for patients in the OMT arm

OMT arm

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Primary Care Pediatrics/Associate Residency Program Director

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 21, 2021
• Study Start: February 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2019
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication
• Access Criteria: From interested OMT researchers