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| Name | Class |
|---|---|
| Medtronic Spine LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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. |
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| 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:
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity) Standard Morphine Equivalent intake | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functioning | Oswestry Disability Index | One Year |
| Quality of Life | SF-36 health survey | One Year |
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Inclusion Criteria:
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:
Current issues of:
Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.
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| Name | Affiliation | Role |
|---|---|---|
| Khalid Malik, M.D. | Department of Anesthesiology, Northwestern University, Feinberg School of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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. |
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| Patient Satisfaction | Patient Global Impression of Change | One Year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |