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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
osteopathic manipulative treatment
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ohio University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MOT

Arm Description

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.

Outcomes

Primary Outcome Measures

MRI T2 signal changes

Secondary Outcome Measures

MRI anatomic changes and EMG changes

Full Information

First Posted
November 21, 2007
Last Updated
April 19, 2017
Sponsor
Ohio University
Collaborators
Osteopathic Heritage Foundations
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1. Study Identification

Unique Protocol Identification Number
NCT00562562
Brief Title
A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain
Acronym
MRI-OMT
Official Title
A Pilot MRI Study of Osteopathic Manipulative Treatment of Acute Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio University
Collaborators
Osteopathic Heritage Foundations

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOT
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative treatment
Intervention Description
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 Outcome Measure Information:
Title
MRI T2 signal changes
Time Frame
within 72 hours
Secondary Outcome Measure Information:
Title
MRI anatomic changes and EMG changes
Time Frame
within 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John N Howell, PhD
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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