Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03415828

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017). The device re-obtained its CE mark in 2017.

A clinical evaluation was performed by bibliographic route in 2016. Clinical data on more than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period.

As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this "Post-Market Clinical Follow-up" (PMCF) study in accordance with Directive 93/42/EEC and MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®.

The study is comparative. The results will evaluate the performance and safety of the CE-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. It will include economic data. Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are authorized products used according to their intended use.

This is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. The primary objective is to compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Pellegrin, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient 18 years of age or older;
  • 2-month refractory pain to conservative treatment, non-surgical patients;
  • Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;
  • Symptomatic for at least 8 weeks despite appropriate medical treatment;
  • Patient who agrees to participate in the study and who signed the informed consent form;
  • Patient with social protection.

Exclusion criteria

  • Previous surgical treatment of the studied disc(s);
  • Patient with pure radicular pain;
  • Sick leave of more than 12 months secondary to the symptoms;
  • Patients who cannot read or write French;
  • History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;
  • Local or general infection, or suspicion of infection;
  • Severe coagulation disorders;
  • Other rheumatic inflammatory disease;
  • Undercurrent serious pathology with life expectancy < 2 years;
  • Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
  • Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection
  • Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.

Treatment and study plan

Ethanol gel

Device

Intradiscal injection of ethanol gel

Other names: DISCOGEL®

Prednisolone Acetate

Drug

Intradiscal infiltration of steroids

Other names: HYDROCORTANCYL 2,5 POUR CENT

Primary outcomes

  1. Short-term efficacy profile

    Time frame: Month 3

    Compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid: percentage of patients with a pain relief defined by a Low Back Pain (LBP) intensity<4 cm on a Local Verbal Rating Scale (0 = no pain to 10 = maximum imaginable pain)

Secondary outcomes

  1. Long-term efficacy profile

    Time frame: Month 12

    Compare the long-term efficacy profile of DISCOGEL® versus intradiscal steroid: Local Verbal Rating Scale: on back, bottom, thigh, leg, foot

  2. Long-term efficacy profile

    Time frame: Month 24

    Compare the long-term efficacy profile of DISCOGEL® versus intradiscal steroid: Local Verbal Rating Scale: on back, bottom, thigh, leg, foot

  3. Short-term safety profile

    Time frame: Month 3

    Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions

  4. Long-term safety profile

    Time frame: Month 12

    Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions

  5. Long-term safety profile

    Time frame: Month 24

    Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions

  6. Questionnaire OSWESTRY

    Time frame: Month 24

    Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale

  7. Questionnaire MacNab

    Time frame: Month 24

    Subjective improvement 24 months after treatment: MacNab scale

  8. Radiography

    Time frame: Month 3

    Describe radiologic evolution of the lesions: radiography of the herniated disc

  9. Radiography

    Time frame: Month 12

    Describe radiologic evolution of the lesions: radiography of the herniated disc

  10. Radiography

    Time frame: Month 24

    Describe radiologic evolution of the lesions: radiography of the herniated disc

  11. Magnetic Resonance Imaging

    Time frame: Month 3

    Describe radiologic evolution of the lesions: MRI of the herniated disc

  12. Procedures costs

    Time frame: Day 0

    Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery

  13. Procedures durations

    Time frame: Day 0

    Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Camélia Bentaleb

CONTACT

[email protected]

Mathieu De Sèze, Dr

CONTACT

[email protected]

+335 56 79 55 16

Sponsors and collaborators

Lead sponsor

Gelscom SAS

Industry

Collaborators

  • CEISO

Registry information

Official study title

Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study

Acronym: IDIS

Important dates

Study start
2018
Primary completion
2024
Study completion
2027
First posted
Jan 30, 2018
Registry last updated
Sep 29, 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.