Conditions Treated With OMTNCT02395965
OMM Utilization in the Clinical Setting
An observational study of Conditions Treated With OMT, run by A.T. Still University of Health Sciences at 17 sites in United States.
Trial 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. . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conditions Treated With OMT
- How many people
- 1,960 participants
- Where
- 17 sitesUnited States
- Study dates
- Jul 2011to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants are recruited from participating physicians' office during patient hours for patients expected to receive OMT.
Who may be able to join
- Adult patients aged 18 years and older
- Patients receiving OMT at a participating clinic
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Feely Center of Optimal Health
Chicago, Illinois, 60611
Jefferson Park Medical Group
Chicago, Illinois, 60646
Crossroads Premiere Health Care
Corvallis, Oregon, 97333
Midwestern University
Downers Grove, Illinois, 60515
Osteopathic Center for the Four Corners
Durango, Colorado, 81301
BMS Integrated Health, PLC
Farmington Hills, Michigan, 48336
Midwestern University Multispecialty Clinic, PC
Glendale, Arizona, 85308
Capital Region Medical Center
Jefferson City, Missouri, 65101
William James Brooks, DO, PC
Kansas City, Missouri, 64152
ATSU-KCOM OMM Clinic
Kirksville, Missouri, 63501
Kirksville Family Medicine
Kirksville, Missouri, 63501
Bee Caves Family Practice
Lakeway, Texas, 78734
Kohn Medical Group
McHenry, Illinois, 60050
Rocky Mountain Integrative Medicine
Ridgway, Colorado, 81432
Elizabeth M. Sasaki, DO
Visalia, California, 93277
New Medical Health Care
Wichita, Kansas, 67203
Walker Family Medicine
Winchester, Tennessee, 37398
About this study
Official title: 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.
Read the 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.
- Conditions
- Conditions Treated With OMT
- Keywords
- Osteopathic manipulative medicine, Osteopathic manipulative treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: Immediately following office visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startJul 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conditions Treated With OMTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,960 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Association
- Responsible party
- Sponsor
- Investigators
- Brian F Degenhardt, DO, Principal investigator, A.T. Still Research Institute, A.T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395965
- Sponsor's protocol ID
- OMM Utilization AOA 11-04-634
- Status last verified
- Jan 2014
- First submitted
- 19 Feb 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31790126
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Effectiveness of Osteopathic Manipulative Medicine (OMM) in the Clinical Setting
- ClinicalTrials.gov ID
- NCT02395965
- Acronym / sponsor ID
- OMM Utilization AOA 11-04-634
- Conditions
- Conditions Treated With OMT
- Keywords
- Osteopathic manipulative medicine, Osteopathic manipulative treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,960 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Collaborators
- American Osteopathic Association
- Study start
- Jul 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants are recruited from participating physicians' office during patient hours for patients expected to receive OMT.
Key inclusion criteria (2 listed)
- Adult patients aged 18 years and older
- Patients receiving OMT at a participating clinic
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 31790126Johnson 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.
- Practice based research network website.Link provided by the sponsor.
Related trials for Conditions Treated With OMT
Not yet recruiting
Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence
Osteopathic Manipulative Treatment (OMT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian F Degenhardt, DO principal investigator
A.T. Still Research Institute, A.T. Still University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conditions Treated With OMT, run by A.T. Still University of Health Sciences at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of Change in Severity of Chief Complaint (time frame: Baseline and 7 days following office visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.