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

NCT ID: NCT00562562

Last Updated: 2017-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

osteopathic manipulative treatment

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osteopathic Heritage Foundations

OTHER

Sponsor Role collaborator

Ohio University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John N Howell, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio University

Locations

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Ohio University

Athens, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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15148

Identifier Type: -

Identifier Source: secondary_id

15148

Identifier Type: -

Identifier Source: org_study_id

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