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OpenTrials
Completed

NCT Number: NCT04764877

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

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.

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Key information

Conditions

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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,)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manipulative Medicine

Other

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

Primary outcomes

  1. Change in FEV1 on pre-therapy and post-therapy PFTs

    Time frame: 2 hours

    FEV1 improvement

  2. Change in FEF25-75 on pre-therapy and post-therapy PFTs

    Time frame: 2 hours

    FEV25-75 improvement

  3. Change in FVC on pre-therapy and post-therapy PFTs

    Time frame: 2 hours

    FVC improvement

  4. Change in FVC/FEV1 on pre-therapy and post-therapy PFTs

    Time frame: 2 hours

    Improvement in ratio

Secondary outcomes

  1. Standardized survey to look for adverse effects from the OMT

    Time frame: 2 hours

    Standard form asking about common AEs seen with OMT

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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