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The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intradiscal Gelified Ethanol Arm | Experimental | Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradiscal Gelified Ethanol (Discogel) | Device | Intradiscal percutaneous injection of an intradiscal Gelified Ethanol |
|
| Measure | Description | Time Frame |
|---|---|---|
| the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months) | In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain cervical intensity using the verbal local rating scale [ | Scores range from 0-10. In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable"). | 12 months |
| Change of consumption of painkillers |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santissima Trinità Hospital Ascagliari | Cagliari | 9121 | Italy |
Confidential data (Pre-market Study trial)
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Number, frequency and dosage of pain relief treatments will be combine todescribe the difference in painkiller consumption before and after the operation |
| 12 months |
| Incidence of complication and adverse event rates | Incidence of adverse event during 12 months after the treatment | 12 months |
| Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment]. | The Neck Disability Index (NDI) is used to measure pain-related disability associated with activities of daily living in people with neck pain (index between 0 and 50). The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, above 34 = complete. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration. | 12 months |
| Subjective evaluation MacNab | The MacNab's scale is layered into 4 levels (excellent, good, fair and poor) according to the patient's well-being after surgery or procedure.The scores were divided into the following four grades: 75-100% (excellent), 50-74% (good), 25-49% (fair) and 0-24% (poor). "Excellent" is defined as "No pain; no restriction of activity". "Good" is defined as "Occasional pain of sufficient severity to interfere with the patient's ability to do his normal work or his capacity to enjoy himself in leisure hours". | 12 months after treatment |
| Azienda Ospedaliera Universitaria | Siena | 53000 | Italy |
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