ClinicalTrials.gov
ClinicalTrials.gov Menu

Large Array EMG Discriminability in Discogenic Low Back Pain

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.
ClinicalTrials.gov Identifier: NCT00220948
Recruitment Status : Unknown
Verified July 2005 by Texas Back Institute.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Sponsor:
Collaborators:
CERSR
Innovative Spinal Technologies, Inc.
Information provided by:
Texas Back Institute

Brief Summary:

Hypothesis:

Myoelectric patterns observed from the CERSR array during standardized testing are sensitive in identifying healthy subjects from patients with internal disc derangement and a positive discogram. A positive CT discogram is defined as one following the Dallas discogram protocol with abnormal disc morphology and reproduction of symptoms


Condition or disease Intervention/treatment Phase
Discogenic Pain Procedure: CERSR Myoelectric monitoring during standardized tasks Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Large Array EMG Discriminability in Discogenic Low Back Pain
Study Start Date : August 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain




Primary Outcome Measures :
  1. Agreement between discogram interpretation and myoelectric interpretation


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients: Failed conservative care > 5 months, Age 21 – 55.VAS > 3.0· The patient has been referred for provocative discogram diagnostic study with a suspected single level internal disc derangement.· Normal psychometric screening.

Healthy Subjects: · Age 21 – 55

Exclusion Criteria:

  • Prior spine surgery.Neurological deficit.·Spinal deformity· Prior spine surgery.·History of disabling back or leg pain.·

Healthy subjects: History of back pain for the past 6 months year.


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): NCT00220948


Contacts
Contact: John J Triano, DC,PhD 972-644-4356 jaytriano@msn.com

Locations
United States, Texas
Texas Back Institute Recruiting
Plano, Texas, United States, 75093
Contact: John J Triano, DC,PhD    972-644-4356    jaytriano@msn.com   
Sub-Investigator: McGregor Marion, DC, MSc         
Sub-Investigator: Richard D Guyer, MD         
Sponsors and Collaborators
Texas Back Institute
CERSR
Innovative Spinal Technologies, Inc.
Investigators
Principal Investigator: John J Triano, DC,PhD Texas Back Institute and University of Texas, Arlington

ClinicalTrials.gov Identifier: NCT00220948     History of Changes
Other Study ID Numbers: P699
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: July 2005

Keywords provided by Texas Back Institute:
discogenic pain
myoelectric activity

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