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

• ClinicalTrials.gov Identifier: NCT01077947
• Recruitment Status: Withdrawn
• First Posted: March 1, 2010
• Last Update Posted: September 13, 2016
• Sponsor: Northwestern University
• Collaborator: Medtronic Spine LLC
• Information provided by: Northwestern University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Discogenic Pain; Low Back Pain	Procedure: Functional anesthetic discography; Procedure: Provocative Discography	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
• Study Start Date: February 2010
• Estimated Primary Completion Date: February 2014
• Estimated Study Completion Date: February 2014

Arms and Interventions

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: Loss of disc signal intensity on T-2 weighted sagittal MR images.; 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: Loss of disc signal intensity on T-2 weighted sagittal MR images.; 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.

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: One Year ]

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

   Standard Morphine Equivalent intake

Secondary Outcome Measures :

1. Physical functioning [ Time Frame: One Year ]
   Oswestry Disability Index
2. Quality of Life [ Time Frame: One Year ]
   SF-36 health survey
3. Patient Satisfaction [ Time Frame: One Year ]
   Patient Global Impression of Change

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Khalid Malik, M.D., Northwestern University
• ClinicalTrials.gov Identifier: NCT01077947
• Other Study ID Numbers: STU00006921
• First Posted: March 1, 2010
• Last Update Posted: September 13, 2016
• Last Verified: September 2016

Keywords provided by Northwestern University:

low back pain; spinal fusion; Primarily axial low back pain

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs