RecruitingNot Applicable

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

France230 participantsStarted 2018-05-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Short-term efficacy profile

Timeframe: Month 3

Trial details

NCT IDNCT03415828

SponsorGelscom SAS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-29

Contact for this trial

Mathieu De Sèze, Dr

+335 56 79 55 16 corinne.pallas@chu-bordeaux.fr

View on ClinicalTrials.gov More Lumbar Discogenic Pain (Disorder) trials