Clinical trial NCT05969392: Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
Official title: Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pain, Cervical
Discogenic Pain
Lead sponsor: Gelscom SAS
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: 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);

Primary outcomes:
measure: 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)
timeFrame: 3 months
Secondary outcomes:
measure: Change in pain cervical intensity using the verbal local rating scale [
timeFrame: 12 months
measure: Change of consumption of painkillers
timeFrame: 12 months
measure: Incidence of complication and adverse event rates
timeFrame: 12 months
measure: Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].
timeFrame: 12 months
measure: Subjective evaluation MacNab
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Santissima Trinità Hospital Ascagliari
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria
Study officials:
References: