Clinical trial NCT02395965: OMM Utilization in the Clinical Setting
Official title: Use and Effectiveness of Osteopathic Manipulative Medicine (OMM) in the Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conditions Treated With OMT
Keywords: Osteopathic manipulative medicine
Osteopathic manipulative treatment
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2015-03-24
Enrollment: 1960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are recruited from participating physicians' office during patient hours for patients expected to receive OMT.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pattern of Change in Severity of Chief Complaint
timeFrame: Baseline and 7 days following office visit
measure: Change in PROMIS Quality of Life Scales
timeFrame: Baseline to 1 week following office visit
measure: Patient-reported Assessment of Change in Overall Health Status
timeFrame: Immediately following office visit
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Midwestern University Multispecialty Clinic, PC
state: Arizona
city: Visalia
country: United States
facility: Elizabeth M. Sasaki, DO
state: California
city: Durango
country: United States
facility: Osteopathic Center for the Four Corners
state: Colorado
city: Ridgway
country: United States
facility: Rocky Mountain Integrative Medicine
state: Colorado
city: Chicago
country: United States
facility: Feely Center of Optimal Health
state: Illinois
city: Chicago
country: United States
facility: Jefferson Park Medical Group
state: Illinois
city: Downers Grove
country: United States
facility: Midwestern University
state: Illinois
city: McHenry
country: United States
facility: Kohn Medical Group
state: Illinois
city: Wichita
country: United States
facility: New Medical Health Care
state: Kansas
city: Farmington Hills
country: United States
facility: BMS Integrated Health, PLC
state: Michigan
city: Jefferson City
country: United States
facility: Capital Region Medical Center
state: Missouri
city: Kansas City
country: United States
facility: William James Brooks, DO, PC
state: Missouri
city: Kirksville
country: United States
facility: ATSU-KCOM OMM Clinic
state: Missouri
city: Kirksville
country: United States
facility: Kirksville Family Medicine
state: Missouri
city: Corvallis
country: United States
facility: Crossroads Premiere Health Care
state: Oregon
city: Winchester
country: United States
facility: Walker Family Medicine
state: Tennessee
city: Lakeway
country: United States
facility: Bee Caves Family Practice
state: Texas
Study officials:
affiliation: A.T. Still Research Institute, A.T. Still University
name: Brian F Degenhardt, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.