NCT00220948

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

September 22, 2005

Status Verified

July 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Discogenic Pain

Keywords

discogenic painmyoelectric activity

Outcome Measures

Primary Outcomes (1)

  • Agreement between discogram interpretation and myoelectric interpretation

Interventions

CERSR Myoelectric monitoring during standardized tasksPROCEDURE

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Back Institute

Plano, Texas, 75093, United States

RECRUITING

Study Officials

  • John J Triano, DC,PhD

    Texas Back Institute and University of Texas, Arlington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John J Triano, DC,PhD

CONTACT

972-644-4356jaytriano@msn.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

August 1, 2004

Study Completion

March 1, 2006

Last Updated

September 22, 2005

Record last verified: 2005-07

Locations

US(1)