Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.

Conditions
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Pain, Cervical, Discogenic Pain

Intervention / Treatment
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* Device: Intradiscal Gelified Ethanol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years or older; Pain refractory to conservative treatments for more than 2 months, non-surgical patients Cervicobrachialgia due to disc herniation Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI; Patient agreeing to participate in the study and having given written consent; Patient enrolled in a health insurance plan. Exclusion Criteria: Prior surgical treatment of the disc(s) studied; Sick leave of more than 12 months secondary to painful symptoms; Patient with Modic 1 score or more History of cognitive-behavioral disorders that could affect the completion of self-questionnaires; Local or systemic infection, or suspicion of infection; Severe coagulation disorders; Other inflammatory rheumatic disease; Severe underlying pathology with life expectancy <1 year; Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0); Known allergy to contrast material and/or local anesthetic substances; Patients who cannot read or write Italian; Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradiscal Gelified Ethanol Arm<br>Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria. | Device: Intradiscal Gelified Ethanol<br>* Intradiscal percutaneous injection of an intradiscal Gelified Ethanol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |