Effect of Osteopathic Manipulation Therapy on Pulmonary F... | NCT04764877

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

NCT04764877

Sponsor

Nationwide Children's Hospital

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

58Actual

Phase

Not Applicable

Conditions

Asthma in Children

Interventions

Osteopathic Manipulative Medicine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2015Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Jan 21, 2021

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alex Rakowsky, Assistant Professor Primary Care Pediatrics/Associate Residency Program Director, Nationwide Children's HospitalPrincipal Investigator

Lead Sponsor

Nationwide Children's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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,)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Osteopathic Manipulative Medicine	Other	Provided 15-20 minute long OMT session for patients in the OMT arm	OMT arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Standardized survey to look for adverse effects from the OMT	Standard form asking about common AEs seen with OMT	2 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

After publication

Access Criteria

From interested OMT researchers

URL

Not provided

Intervention 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.