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The French medicines agency did not allow the continuation of the study (no patient enrolled in this study)
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| Name | Class |
|---|---|
| Gelscom SAS | INDUSTRY |
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Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.
In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DISCOGEL | Experimental | Percutaneous intradiscal injection of Discogel |
|
| conventional treatment | Active Comparator | conventional treatment based on current guidelines regarding the management of discogenic low back pain, including but not limited to: medications (analgesics, NSAIDs, muscle relaxants), physical therapy, manual techniques, transcutaneous electrical nerve stimulation (TENS), blocks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discogel | Device | DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure. | Six months after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS), | Mean pain intensity score on Visual Analog Scale (VAS), one month, three months, six months and 1 year after the procedure ; | one month, three months, six months and 1 year after the procedure |
| Oswestry Disability Index (ODI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CAIRE François, MD | University Hospital, Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Limoges | Limoges | 87042 | France |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| conventional treatment | Other | Conventional treatment based on current guidelines regarding the management of discogenic low back pain, including but not limited to:
|
|
Oswestry Disability Index (ODI) one month, three months, six months and 1 year after the procedure ; |
| one month, three months, six months and 1 year after the procedure |
| Euroqol score | Assessment of the quality of life with Euroqol score (EQ-5D) one month, three months, six months and 1 year after the procedure | month, three months, six months and 1 year after the procedure |