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

NCT01077947 | Withdrawn Phase 4

• 1 other identifier: STU00006921
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain

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

  One Year

Secondary Outcomes (3)

• Physical functioning

  One Year

• Quality of Life

  One Year

• Patient Satisfaction

  One Year

Study Arms (2)

Functional anesthetic discography

ACTIVE COMPARATOR

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

Provocative Discography

ACTIVE COMPARATOR

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

Interventions

Functional anesthetic discography 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.

Functional anesthetic discography

Provocative Discography 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.

Provocative Discography

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21 to 65 years.
• Symptoms of at least 6 months duration.
• Primarily axial low back pain.
• At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc.
• Patients with overall pain scores of greater than 6/10 (NRS).
• Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level.

You may not qualify if:

• History of previous spine surgery.
• MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI.
• Clinical or radiological evidence of significant:
• Disc herniation
• Spinal Stenosis
• Spinal Deformity
• Spondylolisthesis
• Spinal instability or pars-defect
• Facet Syndrome
• Sacroiliac Joint Dysfunction
• Myofascial Pain Syndrome
• Fibromyalgia
• Current issues of:
• Litigation
• Disability

Sponsors & Collaborators

• Northwestern University: lead
• Medtronic Spine LLC: collaborator

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Khalid Malik, M.D.

  Department of Anesthesiology, Northwestern University, Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 1, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 13, 2016

Record last verified: 2016-09