Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

September 9, 2016 updated by: Northwestern University

Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. Patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using FAD compared to similar disc level identification by PD.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 21 to 65 years.
  2. Symptoms of at least 6 months duration.
  3. Primarily axial low back pain.
  4. At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc.
  5. Patients with overall pain scores of greater than 6/10 (NRS).
  6. Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level.

Exclusion Criteria:

  1. History of previous spine surgery.
  2. MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI.

  3. Clinical or radiological evidence of significant:

    1. Disc herniation
    2. Spinal Stenosis
    3. Spinal Deformity
    4. Spondylolisthesis
    5. Spinal instability or pars-defect
    6. Facet Syndrome
    7. Sacroiliac Joint Dysfunction
    8. Myofascial Pain Syndrome
    9. Fibromyalgia

  4. Current issues of:

    1. Litigation
    2. Disability
    3. Drug addiction or substance abuse
    4. Chronic pain medication abuse
  5. Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Functional anesthetic discography

The patients disc levels for surgical treatment will be based exclusively on their Functional anesthetic discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography:

  1. Loss of disc signal intensity on T-2 weighted sagittal MR images.
  2. Loss of disc height on sagittal MR images.

Patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery by research personnel. Patients will be asked to complete questionnaires before their discography and at every follow-up visit.
Procedure: Functional anesthetic discography
Functional anesthetic discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.
ACTIVE_COMPARATOR: Provocative Discography

The patients disc levels for surgical treatment will be based exclusively on their Provocative Discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography:

  1. Loss of disc signal intensity on T-2 weighted sagittal MR images.
  2. Loss of disc height on sagittal MR images.

The control disc, in the case provocative discography group must appear normal on the MRI - must have preserved disc height and central disc signal intensity on T-2 weighted images. The provocative discography will be performed using the standard IASP criteria. The patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery.
Procedure: Provocative Discography
Provocative Discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: One Year

Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity)

Standard Morphine Equivalent intake
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical functioning
Time Frame: One Year
Oswestry Disability Index
One Year
Quality of Life
Time Frame: One Year
SF-36 health survey
One Year
Patient Satisfaction
Time Frame: One Year
Patient Global Impression of Change
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Medtronic Spine LLC

Investigators

  • Principal Investigator: Khalid Malik, M.D., Department of Anesthesiology, Northwestern University, Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ANTICIPATED)

February 1, 2014

Study Completion (ANTICIPATED)

February 1, 2014

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (ESTIMATE)

March 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00006921

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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