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

This study has been withdrawn prior to enrollment.
(Internal)
Sponsor:
Collaborator:
Medtronic Spine LLC
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01077947
First received: February 26, 2010
Last updated: September 15, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Discogenic Pain
Low Back Pain
Procedure: Functional anesthetic discography
Procedure: Provocative Discography
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pain [ Time Frame: One Year ] [ Designated as safety issue: No ]

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

    Standard Morphine Equivalent intake



Secondary Outcome Measures:
  • Physical functioning [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Oswestry Disability Index

  • Quality of Life [ Time Frame: One Year ] [ Designated as safety issue: No ]
    SF-36 health survey

  • Patient Satisfaction [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Patient Global Impression of Change


Estimated Enrollment: 224
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077947

Sponsors and Collaborators
Northwestern University
Medtronic Spine LLC
Investigators
Principal Investigator: Khalid Malik, M.D. Department of Anesthesiology, Northwestern University, Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Khalid Malik, M.D., Northwestern University
ClinicalTrials.gov Identifier: NCT01077947     History of Changes
Other Study ID Numbers: STU00006921
Study First Received: February 26, 2010
Last Updated: September 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
low back pain
spinal fusion
Primarily axial low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014