A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain
MRI-OMT
1 other identifier
interventional
9
1 country
1
Brief Summary
This is a pilot project intended to determine the feasibility of detecting soft tissue changes in response to osteopathic manipulative treatment (OMT). MRIs of the lumbar and pelvic regions of low back pain (LBP) patients will be taken once before and at two different time points after OMT. Images obtained will be quantitatively analyzed for changes in the volumes of back muscles and for changes (T2 signals) indicative of activity levels or pathological conditions. Electromyography (EMG) will be used as an independent measure of back muscle activity for comparison with MRI results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Sep 2007
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 21, 2007
CompletedFirst Posted
Study publicly available on registry
November 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedApril 21, 2017
April 1, 2017
1.3 years
November 21, 2007
April 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
MRI T2 signal changes
within 72 hours
Secondary Outcomes (1)
MRI anatomic changes and EMG changes
within 72 hours
Study Arms (1)
MOT
OTHERTreatment will focus on the thoracolumbar junction, L5, the sacrum, and the pubes. Treatment will primarily utilize two techniques, muscle energy and ligamentous-articular release, but will be tailored to the findings of the individual patient.
Interventions
Treatment will focus on the thoracolumbar junction, L5, the sacrum, and the pubes. Treatment will primarily utilize two techniques, muscle energy and ligamentous-articular release, but will be tailored to the findings of the individual patient.
Eligibility Criteria
You may qualify if:
- Adult patients (18-55)
- Patients with LBP with acute symptoms (within last 3 weeks)
- Test positive for lumbar somatic dysfunction
You may not qualify if:
- History of any spinal injuries/surgeries
- Positive findings of frank neurological signs during physical exam
- Any other orthopedic or neurological impairment
- Unsuitable for MRI imaging:
- Cardiac pacemaker or defibrillator
- Severe Claustrophobia
- Injured by a metallic object that was not removed
- Cochlear (ear) implants
- Surgery involving a metallic implant (e.g. knee replacement)
- Weight more than 300 lbs/136 kg (weight limit for scanner bed)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio Universitylead
- Osteopathic Heritage Foundationscollaborator
Study Sites (1)
Ohio University
Athens, Ohio, 45701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John N Howell, PhD
Ohio University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2007
First Posted
November 22, 2007
Study Start
September 1, 2007
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
April 21, 2017
Record last verified: 2017-04