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A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain (MRI-OMT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Ohio University.   Recruitment status was  Recruiting

First Received on November 21, 2007.   No Changes Posted
Sponsor: Ohio University
Collaborators: Collaborating institution: O'Bleness Memorial Hospital, Athens, OH 45701
Funding source: Osteopathic Heritage Foundations, Columbus, OH
Information provided by: Ohio University
ClinicalTrials.gov Identifier: NCT00562562
  Purpose

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.


Condition Intervention
Low Back Pain
 Other: osteopathic manipulative treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Ohio University:

Primary Outcome Measures:
  • MRI T2 signal changes [ Time Frame: within 72 hours ]

Secondary Outcome Measures:
  • MRI anatomic changes and EMG changes [ Time Frame: within 72 hours ]

Estimated Enrollment: 6
Study Start Date: September 2007
Estimated Study Completion Date: August 2008
Intervention Details:
    Other: osteopathic manipulative treatment
    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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult patients (18-55)
  • Patients with LBP with acute symptoms (within last 3 weeks)
  • Test positive for lumbar somatic dysfunction

Exclusion criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562562

Contacts
Contact: John N Howell, PhD 7405935789 howell@ohio.edu
Contact: Kapil Bajaj, B.S. 7405932233 bajaj@ohio.edu

Locations
United States, Ohio
Ohio University Recruiting
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Collaborating institution: O'Bleness Memorial Hospital, Athens, OH 45701
Funding source: Osteopathic Heritage Foundations, Columbus, OH
Investigators
Principal Investigator: John N Howell, PhD Ohio University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562562     History of Changes
Other Study ID Numbers: 15148, 15148
Study First Received: November 21, 2007
Last Updated: November 21, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012



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