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Completed

NCT Number: NCT00562562

A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Osteopathic manipulative treatment

Other

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.

Primary outcomes

  1. MRI T2 signal changes

    Time frame: within 72 hours

Secondary outcomes

  1. MRI anatomic changes and EMG changes

    Time frame: within 72 hours

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • Osteopathic Heritage Foundations

Registry information

Acronym: MRI-OMT

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 22, 2007
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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