Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

• Status: Recruiting
• Trial end date: 2022-05-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gelscom SAS
• Collaborator: CEISO
• Treatments: Ethanol; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.