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

NCT ID: NCT01077947

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-02-28

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.

Conditions

Discogenic Pain; Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Functional anesthetic discography

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Provocative Discography

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Spine LLC

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Northwestern University

Principal Investigators

Khalid Malik, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Northwestern University, Feinberg School of Medicine

Other Identifiers

STU00006921

Identifier Type: -

Identifier Source: org_study_id