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

Low Back Pain Clinical Trial

— MRI-OMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562562
• Other study ID #: 15148
• Secondary ID: 15148
• Status: Completed
• Phase: N/A
• First received: November 21, 2007
• Last updated: April 19, 2017
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2017
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	Osteopathic Heritage Foundations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI T2 signal changes		within 72 hours
Secondary	MRI anatomic changes and EMG changes		within 72 hours