[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lumbar-discogenic-pain-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lumbar-discogenic-pain-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100317682","ethanol-gel-versus-steroid-in-refractory-lumbar-discogenic-pain-100317682",false,"NCT03415828","Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain","Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study","IDIS","Inclusion Criteria:\n\n* Patient 18 years of age or older;\n* 2-month refractory pain to conservative treatment, non-surgical patients;\n* Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;\n* Symptomatic for at least 8 weeks despite appropriate medical treatment;\n* Patient who agrees to participate in the study and who signed the informed consent form;\n* Patient with social protection.\n\nExclusion Criteria:\n\n* Previous surgical treatment of the studied disc(s);\n* Patient with pure radicular pain;\n* Sick leave of more than 12 months secondary to the symptoms;\n* Patients who cannot read or write French;\n* History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;\n* Local or general infection, or suspicion of infection;\n* Severe coagulation disorders;\n* Other rheumatic inflammatory disease;\n* Undercurrent serious pathology with life expectancy \\\u003C 2 years;\n* Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;\n* Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection\n* Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.","ALL","18 Years",{"count":20,"type":21},230,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nA 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.\n\nAs 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\u002F42\u002FEEC and MEDDEV guide 2.12\u002F2, to assess the efficacy and the long-term safety of DISCOGEL®.\n\nThe 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.\n\nThis 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.",[27],"Lumbar Discogenic Pain (Disorder)","RECRUITING","2025-09-23",{"date":31,"type":32},"2025-09-29","ACTUAL",{"date":34,"type":32},"2018-05-29",{"date":36,"type":21},"2027-05-29",{"name":38,"class":39},"Gelscom SAS","INDUSTRY",5]