[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100317682":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":47,"studyPopulation":47,"armGroups":57,"interventions":70,"overallOfficials":84,"centralContacts":89,"locations":98,"responsibleParty":153,"collaborators":155,"id":158,"slug":47,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":47,"enrollmentInfo":167,"targetDuration":47,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":47,"overallStatus":101,"whyStopped":47,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Gelscom SAS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Short-term efficacy profile","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\\\u003C4 cm on a Local Verbal Rating Scale (0 = no pain to 10 = maximum imaginable pain)","Month 3",[14,18,20,23,25,26,29,32,35,36,37,40,44],{"measure":15,"description":16,"timeFrame":17},"Long-term efficacy profile","Compare the long-term efficacy profile of DISCOGEL® versus intradiscal steroid: Local Verbal Rating Scale: on back, bottom, thigh, leg, foot","Month 12",{"measure":15,"description":16,"timeFrame":19},"Month 24",{"measure":21,"description":22,"timeFrame":12},"Short-term safety profile","Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions",{"measure":24,"description":22,"timeFrame":17},"Long-term safety profile",{"measure":24,"description":22,"timeFrame":19},{"measure":27,"description":28,"timeFrame":19},"Questionnaire OSWESTRY","Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale",{"measure":30,"description":31,"timeFrame":19},"Questionnaire MacNab","Subjective improvement 24 months after treatment: MacNab scale",{"measure":33,"description":34,"timeFrame":12},"Radiography","Describe radiologic evolution of the lesions: radiography of the herniated disc",{"measure":33,"description":34,"timeFrame":17},{"measure":33,"description":34,"timeFrame":19},{"measure":38,"description":39,"timeFrame":12},"Magnetic Resonance Imaging","Describe radiologic evolution of the lesions: MRI of the herniated disc",{"measure":41,"description":42,"timeFrame":43},"Procedures costs","Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery","Day 0",{"measure":45,"description":46,"timeFrame":43},"Procedures durations","Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":54},"DOUBLE",[55,56],"PARTICIPANT","OUTCOMES_ASSESSOR",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Ethanol gel","EXPERIMENTAL","CE-marked medical device used according to its instructions for use: GELSCOM® Single injection in the selected disc(s) of 0.6 to 2.2 ml",[63],"Device: Ethanol gel",{"label":65,"type":66,"description":67,"interventionNames":68},"Steroid infiltration","ACTIVE_COMPARATOR","Authorized drug used according to its summary product characteristics: HYDROCORTANCYL 2,5 POUR CENT Single injection in the selected disc(s) of 0.2 to 2.0 ml",[69],"Drug: Prednisolone acetate",[71,77],{"type":72,"name":59,"description":73,"armGroupLabels":74,"otherNames":75},"DEVICE","Intradiscal injection of ethanol gel",[59],[76],"DISCOGEL®",{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"DRUG","Prednisolone acetate","Intradiscal infiltration of steroids",[65],[83],"HYDROCORTANCYL 2,5 POUR CENT",[85],{"name":86,"affiliation":87,"role":88},"Mathieu de Sèze, Dr","CHU Bordeaux Pellegrin","STUDY_CHAIR",[90,95],{"name":91,"role":92,"phone":93,"phoneExt":47,"email":94},"Mathieu De Sèze, Dr","CONTACT","+335 56 79 55 16","corinne.pallas@chu-bordeaux.fr",{"name":96,"role":92,"phone":47,"phoneExt":47,"email":97},"Camélia Bentaleb","camelia.bentaleb@ceiso.fr",[99,114,123,134,145],{"facility":100,"status":101,"city":102,"state":47,"zip":47,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Hospital Pellegrin","RECRUITING","Bordeaux","France","FR",{"type":106,"coordinates":107},"Point",[108,109],-0.58046,44.84124,{"lat":109,"lon":108},[112],{"name":113,"role":92,"phone":47,"phoneExt":47,"email":47},"Mathieu de Sèze, Pr.",{"facility":115,"status":116,"city":117,"state":47,"zip":47,"country":103,"countryCode":104,"cosmosGeoPoint":118,"geoPoint":122,"contacts":47},"Hospital St-Dié-des-Vosges","TERMINATED","Saint-Dié",{"type":106,"coordinates":119},[120,121],6.94921,48.28429,{"lat":121,"lon":120},{"facility":124,"status":101,"city":125,"state":47,"zip":47,"country":103,"countryCode":104,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Hospital SUD La Reunion","Saint-Pierre",{"type":106,"coordinates":127},[128,129],5.40682,43.29282,{"lat":129,"lon":128},[132],{"name":133,"role":92,"phone":47,"phoneExt":47,"email":47},"Romain Kohlmann, Dr.",{"facility":135,"status":101,"city":136,"state":47,"zip":47,"country":103,"countryCode":104,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Hospital St-Etienne","Saint-Priest-en-Jarez",{"type":106,"coordinates":138},[139,140],4.37678,45.4739,{"lat":140,"lon":139},[143],{"name":144,"role":92,"phone":47,"phoneExt":47,"email":47},"Sylvain Grange, Dr.",{"facility":146,"status":116,"city":147,"state":47,"zip":47,"country":103,"countryCode":104,"cosmosGeoPoint":148,"geoPoint":152,"contacts":47},"Hospital Valence","Valence",{"type":106,"coordinates":149},[150,151],4.90956,44.9256,{"lat":151,"lon":150},{"type":154,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[156],{"name":157,"class":6},"CEISO","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":168,"type":169},230,"ESTIMATED","INTERVENTIONAL",[172],"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.",[175],"Lumbar Discogenic Pain (Disorder)","2025-09-23",{"date":178,"type":179},"2025-09-29","ACTUAL",{"date":181,"type":179},"2018-05-29",{"date":183,"type":169},"2027-05-29",{"name":5,"class":6},5]