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

NCT05969392 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CLI01068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Cervical; Discogenic Pain

Outcome Measures

Primary Outcomes (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)

  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 Outcomes (5)

• Change in pain cervical intensity using the verbal local rating scale [

  12 months

• Change of consumption of painkillers

  12 months

• Incidence of complication and adverse event rates

  12 months

• Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].

  12 months

• Subjective evaluation MacNab

  12 months after treatment

Study Arms (1)

Intradiscal Gelified Ethanol Arm

EXPERIMENTAL

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

Device: Intradiscal Gelified Ethanol (Discogel)

Interventions

Intradiscal Gelified Ethanol (Discogel) DEVICE

Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

Intradiscal Gelified Ethanol Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Gelscom SAS: lead

Study Sites (2)

Santissima Trinità Hospital Ascagliari

Cagliari, 9121, Italy

Location

Azienda Ospedaliera Universitaria

Siena, 53000, Italy

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 1, 2023
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)