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NCT Number: NCT05969392

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

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

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Santissima Trinità Hospital Ascagliari, Cagliari, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Intradiscal Gelified Ethanol (Discogel)

Device

Intradiscal percutaneous injection of an intradiscal Gelified Ethanol

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)

    Time frame: 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").

Secondary outcomes

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

    Time frame: 12 months

    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").

  2. Change of consumption of painkillers

    Time frame: 12 months

    Number, frequency and dosage of pain relief treatments will be combine todescribe the difference in painkiller consumption before and after the operation

  3. Incidence of complication and adverse event rates

    Time frame: 12 months

    Incidence of adverse event during 12 months after the treatment

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

    Time frame: 12 months

    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.

  5. Subjective evaluation MacNab

    Time frame: 12 months after treatment

    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".

Sponsors and collaborators

Lead sponsor

Gelscom SAS

Industry

Registry information

Official study title

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

Acronym: DISCOCERV

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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