[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416213":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":24,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Xylocaine","ACTIVE_COMPARATOR","Nerve block",[13],"Diagnostic Test: Xylocaine 1%",{"label":15,"type":16,"description":11,"interventionNames":17},"Isotonic saline","PLACEBO_COMPARATOR",[18],"Diagnostic Test: NaCl 9mg\u002Fml",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Xylocaine 1%",[9],null,{"type":21,"name":26,"description":11,"armGroupLabels":27,"otherNames":24},"NaCl 9mg\u002Fml",[15],[29],{"name":30,"affiliation":31,"role":32},"Ellen L Schaldemose, MD","Danish Pain Research Center, Aarhus University","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","+45 93501942","ells@clin.au.dk",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Danish Pain Research Center, Aarhus University, Aarhus University Hospital","RECRUITING","Aarhus N","Jutland","8200","Denmark","DK",{"type":48,"coordinates":49},"Point",[50,51],10.17317,56.20367,{"lat":51,"lon":50},[54],{"name":30,"role":35,"phone":55,"phoneExt":24,"email":37},"93501942",{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100416213","peripheral-nerve-block-in-patients-with-painful-diabetic-polyneuropathy-100416213",false,"NCT04699734","Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy","Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Probably diabetic neuropathy confirmed using the Toronto criteria in a \"conservative manner\", i.e. three out of three symptoms\u002Fsigns of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes) 7.\n* Definite or probable neuropathic pain for minimum the last 6 months\n* Mean pain intensity at \\> 4 NRS the last week17.\n\nSince we expect a large effect of the block it is not necessary to discontinue pain medication.\n\nExclusion Criteria:\n\n* Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain.\n* Unable to understand and speak Danish.\n* Non-cooperative.\n* Warfarin or other medication that contraindicate regional anesthesia.\n* Infection in the injection area.\n* Allergy to lidocaine.\n* Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception).\n* Severe psychiatric disease e.g. severe depression during the last 6 months.\n* Alcohol or drug abuse.","ALL","18 Years",{"count":68,"type":69},16,"ESTIMATED","INTERVENTIONAL",[72],"NA","The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy",[75,76,77],"Painful Diabetic Neuropathy","Neuropathic Pain","Neuropathy;Peripheral","2021-01-06",{"date":80,"type":81},"2021-01-07","ACTUAL",{"date":83,"type":81},"2020-09-08",{"date":85,"type":69},"2026-12-31",{"name":5,"class":6},1]