- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00220948
Large Array EMG Discriminability in Discogenic Low Back Pain
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John J Triano, DC,PhD
- Phone Number: 972-644-4356
- Email: jaytriano@msn.com
Study Locations
-
-
Texas
-
Plano, Texas, United States, 75093
- Recruiting
- Texas Back Institute
-
Contact:
- John J Triano, DC,PhD
- Phone Number: 972-644-4356
- Email: jaytriano@msn.com
-
Sub-Investigator:
- McGregor Marion, DC, MSc
-
Sub-Investigator:
- Richard D Guyer, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Agreement between discogram interpretation and myoelectric interpretation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John J Triano, DC,PhD, Texas Back Institute and University of Texas, Arlington
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P699
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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