OMM Utilization in the Clinical Setting

NCT ID: NCT02395965

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-08-31

Brief Summary

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The SPECIFIC AIM of this research study is to evaluate the utilization, effectiveness, and safety of osteopathic manipulative treatment (OMT) using data collected from patients receiving OMT in the clinical setting within the established practice-based research network DO-Touch.NET.

. The HYPOTHESES of this research study are the following:

* OMT is primarily used in the treatment of musculoskeletal pain disorders.
* Patients receiving OMT will have decreased symptoms and improved quality-of-life.
* The most common side effect reported by patients receiving OMT will be muscle soreness.

Detailed Description

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While many physicians and patients are convinced of the efficacy of osteopathic manipulative treatment (OMT), strong evidence supporting such a claim is sparse.

The objectives of this study are to determine the scope of conditions currently being treated with OMT, identify conditions that are responsive and unresponsive to OMT, determine which osteopathic manipulative techniques are most beneficial in responsive conditions, determine if certain patient characteristics are present in those who are responsive to OMT, and determine which physicians have consistently positive outcomes with OMT for certain conditions.

As an observational study, this study will not impact any aspect of the care received by the patient participants. Data will be collected from patients and physicians through a series of questionnaires incorporated into an online data collection system. DO-Touch.NET will be utilized for physician recruitment, site personnel training, members portal for accessing study materials, coordination, and physician data collection. Assessment Center will be used for participant registration, data collection and study tracking/reporting. Patients aged 18 years and older who receive OMT from a participating physician at a DO-Touch.NET site will be recruited to participate in the study. Background data will be collected from the patients including demographics, presenting symptoms and severity, and impact on quality of life. Data on medical history, examination, diagnosis, treatment, and home instructions/plan will be gathered from the physician. On a daily basis for a week after OMT, data will be collected from the patient regarding symptom severity and health changes. Impact of symptoms on quality of life will be reassessed after one week. These data will be collected from a patient over a series of office visits when applicable.

Ongoing observation of both positive and negative outcomes associated with OMT directly from patients will be increasingly more valuable, producing and sustaining a current evidence base for OMT and identifying priorities for further osteopathic research.

Conditions

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Conditions Treated With OMT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients aged 18 years and older
* Patients receiving OMT at a participating clinic

Exclusion Criteria

* Patients with difficulty communicating in English, have dementia, or have psychological conditions that may impact their ability to provide accurate information
* Research team members and participating clinic employees
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Osteopathic Association

OTHER

Sponsor Role collaborator

A.T. Still University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian F Degenhardt, DO

Role: PRINCIPAL_INVESTIGATOR

A.T. Still Research Institute, A.T. Still University

Locations

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Midwestern University Multispecialty Clinic, PC

Glendale, Arizona, United States

Site Status

Elizabeth M. Sasaki, DO

Visalia, California, United States

Site Status

Osteopathic Center for the Four Corners

Durango, Colorado, United States

Site Status

Rocky Mountain Integrative Medicine

Ridgway, Colorado, United States

Site Status

Feely Center of Optimal Health

Chicago, Illinois, United States

Site Status

Jefferson Park Medical Group

Chicago, Illinois, United States

Site Status

Midwestern University

Downers Grove, Illinois, United States

Site Status

Kohn Medical Group

McHenry, Illinois, United States

Site Status

New Medical Health Care

Wichita, Kansas, United States

Site Status

BMS Integrated Health, PLC

Farmington Hills, Michigan, United States

Site Status

Capital Region Medical Center

Jefferson City, Missouri, United States

Site Status

William James Brooks, DO, PC

Kansas City, Missouri, United States

Site Status

ATSU-KCOM OMM Clinic

Kirksville, Missouri, United States

Site Status

Kirksville Family Medicine

Kirksville, Missouri, United States

Site Status

Crossroads Premiere Health Care

Corvallis, Oregon, United States

Site Status

Walker Family Medicine

Winchester, Tennessee, United States

Site Status

Bee Caves Family Practice

Lakeway, Texas, United States

Site Status

Countries

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United States

References

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Johnson JC, Degenhardt BF. Who Uses Osteopathic Manipulative Treatment? A Prospective, Observational Study Conducted by DO-Touch.NET. J Am Osteopath Assoc. 2019 Dec 1;119(12):802-812. doi: 10.7556/jaoa.2019.133.

Reference Type DERIVED
PMID: 31790126 (View on PubMed)

Related Links

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http://www.DO-Touch.NET

Practice based research network website.

Other Identifiers

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OMM Utilization AOA 11-04-634

Identifier Type: -

Identifier Source: org_study_id

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