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This study has been withdrawn prior to enrollment.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

February 26, 2010
September 15, 2010
February 2010
February 2014   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01077947 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Discogenic Pain
  • Low Back Pain
  • 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.
  • 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.
  • 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.

    Intervention: Procedure: Functional anesthetic discography
  • 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.

    Intervention: Procedure: Provocative Discography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
224
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01077947
STU00006921
No
Khalid Malik, M.D., Northwestern University
Northwestern University
Medtronic Spine LLC
Principal Investigator: Khalid Malik, M.D. Department of Anesthesiology, Northwestern University, Feinberg School of Medicine
Northwestern University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP