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

Phase 4

Withdrawn

• Conditions: Discogenic Pain; Low Back Pain
• Interventions: Procedure: Provocative Discography; Procedure: Functional anesthetic discography

• Registration Number: NCT01077947
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Provocative Discography	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.
Functional anesthetic discography	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.

Primary Outcome Measures

Name	Time	Method
Pain	One Year	Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity); Standard Morphine Equivalent intake

Secondary Outcome Measures

Name	Time	Method
Physical functioning	One Year	Oswestry Disability Index
Quality of Life	One Year	SF-36 health survey
Patient Satisfaction	One Year	Patient Global Impression of Change