[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645418":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":11,"studyPopulation":11,"armGroups":42,"interventions":55,"overallOfficials":11,"centralContacts":62,"locations":68,"responsibleParty":83,"collaborators":11,"id":85,"slug":11,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":106,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in Quick DASH scores between baseline and M3",null,"3 months",[14,18,20,22,25,28,30],{"measure":15,"description":16,"timeFrame":17},"1. Functional Assessment","Function using the Quick Dash","D0, Month 1, Month 3, Month 6, month 12",{"measure":15,"description":19,"timeFrame":17},"Function using the SPADI scores",{"measure":15,"description":21,"timeFrame":17},"Function using the OSS",{"measure":23,"description":11,"timeFrame":24},"Measuring Joint Ranges of Motion with a Goniometer","Day 0, Month 1, Month 3, Month 6, and Month 12",{"measure":26,"description":27,"timeFrame":17},"Pain Assessment","With VAS (Visual Analog Scale) 0-10",{"measure":29,"description":11,"timeFrame":24},"EVA pain before and after each movement",{"measure":31,"description":11,"timeFrame":32},"Return-to-work timelines following the procedure for patients who are employed","Month 1, Month 3, Month 6, and Month 12",{"allocation":34,"interventionModel":35,"interventionModelDescription":11,"primaryPurpose":36,"observationalModel":11,"timePerspective":11,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":11,"whoMasked":39},"DOUBLE",[40,41],"PARTICIPANT","OUTCOMES_ASSESSOR",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Diprostene","EXPERIMENTAL","Supracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®.\n\nIntra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.",[48],"Drug: Diprostene",{"label":50,"type":51,"description":52,"interventionNames":53},"Saline Solution","PLACEBO_COMPARATOR","Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline.\n\nIntra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.",[54],"Drug: Saline (0.9% NaCl)",[56,59],{"type":57,"name":44,"description":46,"armGroupLabels":58,"otherNames":11},"DRUG",[44],{"type":57,"name":60,"description":52,"armGroupLabels":61,"otherNames":11},"Saline (0.9% NaCl)",[50],[63],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"Paul ARNOLFO Paul, PH","CONTACT","02 44 76 81 79","Paul.arnolfo@chu-nantes.fr",[69],{"facility":70,"status":11,"city":71,"state":11,"zip":11,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"CHU de Nantes","Nantes","France","FR",{"type":75,"coordinates":76},"Point",[77,78],-1.55336,47.21725,{"lat":78,"lon":77},[81],{"name":82,"role":65,"phone":66,"phoneExt":11,"email":67},"Paul Arnolfo, PH",{"type":84,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100645418",false,"NCT07680504","A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis","EBLOUIR","Inclusion Criteria:\n\n* Patients with shoulder pain and stiffness that has persisted for at least 2 months but less than 12 months, with a loss of passive range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, forward flexion) of at least 30 degrees compared to the contralateral side\n* Patients between the ages of 18 and 65\n* Patients enrolled in a social security program\n\nExclusion Criteria:\n\n* \\- Corticosteroid injection into the affected shoulder \\\u003C 4 months ago\n* History of any surgery on the affected shoulder within the past 12 months\n* Patients with a neuromuscular condition (neurological deficit) or shoulder condition (arthropathy) that could interfere with the assessment of the primary endpoint\n* Signs or risk of infection (bacterial-like infection and\u002For fever and\u002For antibiotic use)\n* Poor skin condition of the affected shoulder\n* Anticoagulation with VKAs or anti-Xa agents, or active bleeding disorder or one in remission for less than 5 years (malignant hematologic disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents permitted except prasugrel and clopidogrel)\\*\n* Uncontrolled hypertension,\n* Decompensated diabetes or diabetes at risk of decompensation,\n* Contraindications to diprosten, Kenacort, or lidocaine\n* Psychiatric conditions that may be exacerbated by corticosteroids\n* Pregnant or breastfeeding women, or women who refuse to use effective contraception\n* Individuals belonging to a vulnerable group as defined by Regulation (EU) No. 536\u002F2014 and French law (See section 4.4 of the protocol) - - Patients unable to comply with the protocol requirements (see Section 4.4 of the protocol)\n* Patients participating in another clinical research protocol involving a drug or medical device\n* Patients who refuse to participate in the study","ALL","18 Years","65 Years",{"count":95,"type":96},38,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","Drug Trial\n\n* Single-center\n* Exploratory trial\n* Controlled\n* Randomized\n* Double-blind\n* Prospective\n\nObjective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection combined with a placebo block 19 patients in the Experimental Group (block with corticosteroid and intra-articular injection on Day 0) 19 patients in the Control Group (block with saline and intra-articular injection on Day 0)\n\n* Total duration: 36 months\n* Recruitment period: 24 months\n* Treatment duration per patient: 2 ultrasound-guided procedures on Day 0\n* Follow-up duration per patient: 12 months after the procedure\n\nAt J0 : Under ultrasound guidance, inject 2 mL of lidocaine into the notch, then:\n\n* Experimental Group: 8 mL of 1% lidocaine into the notch with 1 mL of betamethasone,\n* Control Group: 9 mL of saline into the notch.\n\nDuring these consultations, M1, M3, M6 et M12 , the following examinations will be performed:\n\n* Clinical examination of the painful shoulder, including measurement of range of motion\n* Visual Analog Scale (VAS) for pain\n* Quick Dash, OSS, and SPADI self-report questionnaires completed by the patient\n* Recording of complications\n* Questions about returning to work",[102],"Retractile Capsulitis",[104,105],"suprascapular nerve block","intra-articular injection","NOT_YET_RECRUITING","2026-06-25",{"date":109,"type":110},"2026-07-02","ACTUAL",{"date":107,"type":96},{"date":113,"type":96},"2029-06-25",{"name":5,"class":6},1]