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Large Array EMG Discriminability in Discogenic Low Back Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Texas Back Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
CERSR
Innovative Spinal Technologies, Inc.
Information provided by:
Texas Back Institute
ClinicalTrials.gov Identifier:
NCT00220948
First received: September 13, 2005
Last updated: NA
Last verified: July 2005
History: No changes posted
  Purpose

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 Intervention
Discogenic Pain
 Procedure: CERSR Myoelectric monitoring during standardized tasks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Large Array EMG Discriminability in Discogenic Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Texas Back Institute:

Primary Outcome Measures:
  • Agreement between discogram interpretation and myoelectric interpretation

Estimated Enrollment: 60
Study Start Date: August 2004
Estimated Study Completion Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220948     History of Changes
Other Study ID Numbers: P699
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013