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A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain (MRI-OMT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00562562
First Posted: November 22, 2007
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Osteopathic Heritage Foundations
Information provided by (Responsible Party):
Ohio University
  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: None (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:


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 ]

Enrollment: 9
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MOT
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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562562


Locations
United States, Ohio
Ohio University
Athens, Ohio, United States, 45701
Sponsors and Collaborators
Ohio University
Osteopathic Heritage Foundations
Investigators
Principal Investigator: John N Howell, PhD Ohio University
  More Information

Responsible Party: Ohio University
ClinicalTrials.gov Identifier: NCT00562562     History of Changes
Other Study ID Numbers: 15148
First Submitted: November 21, 2007
First Posted: November 22, 2007
Last Update Posted: April 21, 2017
Last Verified: April 2017

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