NCT02395965

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
Last Updated

March 24, 2015

Status Verified

January 1, 2014

Enrollment Period

3.1 years

First QC Date

February 19, 2015

Last Update Submit

March 18, 2015

Conditions

Conditions Treated With OMT

Keywords

Osteopathic manipulative medicineOsteopathic manipulative treatment

Outcome Measures

Primary Outcomes (3)

  • Pattern of Change in Severity of Chief Complaint

    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

    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

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Midwestern University Multispecialty Clinic, PC

Glendale, Arizona, 85308, United States

Location

Elizabeth M. Sasaki, DO

Visalia, California, 93277, United States

Location

Osteopathic Center for the Four Corners

Durango, Colorado, 81301, United States

Location

Rocky Mountain Integrative Medicine

Ridgway, Colorado, 81432, United States

Location

Feely Center of Optimal Health

Chicago, Illinois, 60611, United States

Location

Jefferson Park Medical Group

Chicago, Illinois, 60646, United States

Location

Midwestern University

Downers Grove, Illinois, 60515, United States

Location

Kohn Medical Group

McHenry, Illinois, 60050, United States

Location

New Medical Health Care

Wichita, Kansas, 67203, United States

Location

BMS Integrated Health, PLC

Farmington Hills, Michigan, 48336, United States

Location

Capital Region Medical Center

Jefferson City, Missouri, 65101, United States

Location

William James Brooks, DO, PC

Kansas City, Missouri, 64152, United States

Location

ATSU-KCOM OMM Clinic

Kirksville, Missouri, 63501, United States

Location

Kirksville Family Medicine

Kirksville, Missouri, 63501, United States

Location

Crossroads Premiere Health Care

Corvallis, Oregon, 97333, United States

Location

Walker Family Medicine

Winchester, Tennessee, 37398, United States

Location

Bee Caves Family Practice

Lakeway, Texas, 78734, United States

Location

Related Publications (1)

  • 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.

    PMID: 31790126DERIVED

Related Links

Study Officials

  • Brian F Degenhardt, DO

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2015

First Posted

March 24, 2015

Study Start

July 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 24, 2015

Record last verified: 2014-01

Locations

US(17)