OMM Utilization in the Clinical Setting

Study Overview
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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.

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

Conditions
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Conditions Treated With OMT

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic manipulative medicine, Osteopathic manipulative treatment