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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01077947
• Other study ID #: STU00006921
• Status: Withdrawn
• Phase: Phase 4
• First received: February 26, 2010
• Last updated: September 9, 2016
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: September 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Back Pain
• Discogenic Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Medtronic Spine LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity); Standard Morphine Equivalent intake	One Year	No
Secondary	Physical functioning	Oswestry Disability Index	One Year	No
Secondary	Quality of Life	SF-36 health survey	One Year	No
Secondary	Patient Satisfaction	Patient Global Impression of Change	One Year	No