Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogen… (NCT05969392) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain
Italy60 participantsStarted 2025-04
Plain-language summary
The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
What they're measuring
1
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)