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Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

RecruitingNAAges 18 Years - anyAllGelscom SAS
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In plain words

What the trial is, and whether it could suit you

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 stan

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Ethanol gel
  • Prednisolone acetate
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Where

5 sites
Hospital Pellegrin
Bordeaux, France
Hospital St-Dié-des-Vosges
Saint-Dié, France
Hospital SUD La Reunion
Saint-Pierre, France
Hospital St-Etienne
Saint-Priest-en-Jarez, France
Hospital Valence
Valence, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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