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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-04-30

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.

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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

Conditions

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Pain, Cervical Discogenic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intradiscal Gelified Ethanol Arm

Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria.

Group Type EXPERIMENTAL

Intradiscal Gelified Ethanol (Discogel)

Intervention Type DEVICE

Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Interventions

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Intradiscal Gelified Ethanol (Discogel)

Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Intervention Type DEVICE

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);

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No