Clinical Trials in Italy / NCT05969392
Starting soon
Phase 2/3
Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
NCT05969392 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Pain, CervicalDiscogenic Pain
Investigational drug(s) / intervention(s)
Intradiscal Gelified Ethanol (Discogel)
Intradiscal Gelified Ethanol (Discogel): Intradiscal percutaneous injection of an intradiscal Gelified Ethanol
Study summary
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Eligibility
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 outcome measure(s)
- 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) — 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").
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Santissima Trinità Hospital Ascagliari | Cagliari | Italy | |
| Azienda Ospedaliera Universitaria | Siena | Italy |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05969392 on ClinicalTrials.gov ↗ ← All trials in Italy