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

Primary Purpose

Asthma in Children

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Osteopathic Manipulative Medicine
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring OMM

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard Care

    OMT arm

    Arm 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

    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)

    Outcomes

    Primary Outcome Measures

    Change in FEV1 on pre-therapy and post-therapy PFTs
    FEV1 improvement
    Change in FEF25-75 on pre-therapy and post-therapy PFTs
    FEV25-75 improvement
    Change in FVC on pre-therapy and post-therapy PFTs
    FVC improvement
    Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
    Improvement in ratio

    Secondary Outcome Measures

    Standardized survey to look for adverse effects from the OMT
    Standard form asking about common AEs seen with OMT

    Full Information

    First Posted
    January 21, 2021
    Last Updated
    February 18, 2021
    Sponsor
    Nationwide Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04764877
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2015 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nationwide Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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,)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma in Children
    Keywords
    OMM

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm 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
    Arm Title
    OMT arm
    Arm Type
    Experimental
    Arm 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)
    Intervention Type
    Other
    Intervention Name(s)
    Osteopathic Manipulative Medicine
    Intervention Description
    Provided 15-20 minute long OMT session for patients in the OMT arm
    Primary Outcome Measure Information:
    Title
    Change in FEV1 on pre-therapy and post-therapy PFTs
    Description
    FEV1 improvement
    Time Frame
    2 hours
    Title
    Change in FEF25-75 on pre-therapy and post-therapy PFTs
    Description
    FEV25-75 improvement
    Time Frame
    2 hours
    Title
    Change in FVC on pre-therapy and post-therapy PFTs
    Description
    FVC improvement
    Time Frame
    2 hours
    Title
    Change in FVC/FEV1 on pre-therapy and post-therapy PFTs
    Description
    Improvement in ratio
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Standardized survey to look for adverse effects from the OMT
    Description
    Standard form asking about common AEs seen with OMT
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Study is completed and pending publication in the Journal of Osteopathic Medicine (formerly JAOA) Once published we do plan to share data with those interested
    IPD Sharing Time Frame
    After publication
    IPD Sharing Access Criteria
    From interested OMT researchers

    Learn more about this trial

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

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