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

Study Overview
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Brief Summary
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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.

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

Conditions
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Discogenic Pain, Low Back Pain

Intervention / Treatment
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* Procedure: Functional anesthetic discography
* Procedure: Provocative Discography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 Drug addiction or substance abuse Chronic pain medication abuse Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Functional anesthetic discography<br>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<br>* 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.<br>|
| Active Comparator: Provocative Discography<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity) Standard Morphine Equivalent intake | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning | Oswestry Disability Index | One Year | 
| Quality of Life | SF-36 health survey | One Year | 
| Patient Satisfaction | Patient Global Impression of Change | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, spinal fusion, Primarily axial low back pain