OMM Utilization in the Clinical Setting

March 18, 2015 updated by: A.T. Still University of Health Sciences

Use and Effectiveness of Osteopathic Manipulative Medicine (OMM) in the Clinical Setting

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1960

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Midwestern University Multispecialty Clinic, PC
    • California
      • Visalia, California, United States, 93277
        • Elizabeth M. Sasaki, DO
    • Colorado
      • Durango, Colorado, United States, 81301
        • Osteopathic Center for the Four Corners
      • Ridgway, Colorado, United States, 81432
        • Rocky Mountain Integrative Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Feely Center of Optimal Health
      • Chicago, Illinois, United States, 60646
        • Jefferson Park Medical Group
      • Downers Grove, Illinois, United States, 60515
        • Midwestern University
      • McHenry, Illinois, United States, 60050
        • Kohn Medical Group
    • Kansas
      • Wichita, Kansas, United States, 67203
        • New Medical Health Care
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • BMS Integrated Health, PLC
    • Missouri
      • Jefferson City, Missouri, United States, 65101
        • Capital Region Medical Center
      • Kansas City, Missouri, United States, 64152
        • William James Brooks, DO, PC
      • Kirksville, Missouri, United States, 63501
        • ATSU-KCOM OMM Clinic
      • Kirksville, Missouri, United States, 63501
        • Kirksville Family Medicine
    • Oregon
      • Corvallis, Oregon, United States, 97333
        • Crossroads Premiere Health Care
    • Tennessee
      • Winchester, Tennessee, United States, 37398
        • Walker Family Medicine
    • Texas
      • Lakeway, Texas, United States, 78734
        • Bee Caves Family Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study participants are recruited from participating physicians' office during patient hours for patients expected to receive OMT.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern of Change in Severity of Chief Complaint
Time Frame: Baseline and 7 days following office visit
Patient-reported severity level of chief complaint measured at baseline and daily for 7 days following office visit on an 11-point numeric rating scale (0=no problem, 10=worst imaginable).
Baseline and 7 days following office visit
Change in PROMIS Quality of Life Scales
Time Frame: Baseline to 1 week following office visit
Select quality of life scales (fatigue, pain-interference, physical function, sleep disturbance) from the Patient Reported Outcomes Measurement Information System (PROMIS).
Baseline to 1 week following office visit
Patient-reported Assessment of Change in Overall Health Status
Time Frame: Immediately following office visit
Assessment of how patient feels immediate following office visit overall compared to before office visit on 5-point ordinal scale (much better, better, about the same, worse, much worse)
Immediately following office visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.T. Still University of Health Sciences

Collaborators

American Osteopathic Association

Investigators

  • Principal Investigator: Brian F Degenhardt, DO, A.T. Still Research Institute, A.T. Still University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (ESTIMATE)

March 24, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMM Utilization AOA 11-04-634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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