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

Discogenic Pain Clinical Trial

— DISCERV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05969392
• Other study ID #: CLI01068
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: October 2023
• Est. completion date: May 2025

Study information

• Verified date: July 2023
• Source: Gelscom SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

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);

Related Conditions & MeSH terms

• Discogenic Pain
• Neck Pain

Intervention

Device:
• Intradiscal Gelified Ethanol
Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Locations

Country	Name	City	State
Italy	Santissima Trinità Hospital Ascagliari	Cagliari
Italy	Azienda Ospedaliera Universitaria	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Gelscom SAS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Incidence of complication and adverse event rates	Incidence of adverse event during 12 months after the treatment	12 months
Secondary	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
Secondary	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