[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100365544":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":37,"locations":46,"responsibleParty":102,"collaborators":104,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":25,"eligibilityCriteria":112,"healthyVolunteers":109,"sex":113,"minAge":114,"maxAge":25,"enrollmentInfo":115,"targetDuration":25,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"St. Olavs Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Burst spinal cord stimulation (SCS)","EXPERIMENTAL","following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.",[13,14],"Procedure: Burst Spinal Cord Stimulation","Procedure: Sham spinal cord stimulation",{"label":16,"type":17,"description":11,"interventionNames":18},"sham spinal cord stimulation (SCS)","SHAM_COMPARATOR",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Burst Spinal Cord Stimulation","Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham spinal cord stimulation","A pulse generator is implanted, but no spinal cord stimulation is provided",[9,16],[31,34],{"name":32,"affiliation":5,"role":33},"Sasha Gulati, md prof","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":36},"Geir Bråthen, md prof","STUDY_DIRECTOR",[38,42],{"name":32,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","+47 73592020","sasha.gulati@ntnu.no",{"name":43,"role":39,"phone":44,"phoneExt":25,"email":45},"Sven M Carlsen, md prof","+47 91769528","sven.carlsen@ntnu.no",[47,62,73,84],{"facility":48,"status":49,"city":50,"state":25,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Halden Dermatology Center","RECRUITING","Halden","Norway","NO",{"type":54,"coordinates":55},"Point",[56,57],11.38754,59.12478,{"lat":57,"lon":56},[60],{"name":61,"role":39,"phone":25,"phoneExt":25,"email":25},"Alexandros L Stefou, md",{"facility":63,"status":49,"city":64,"state":25,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Aleris","Strømmen",{"type":54,"coordinates":66},[67,68],11.01009,59.95063,{"lat":68,"lon":67},[71],{"name":72,"role":39,"phone":25,"phoneExt":25,"email":25},"Mari S Kvernebo, md",{"facility":74,"status":49,"city":75,"state":25,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Universitetssykehuset nord-norge hf","Tromsø",{"type":54,"coordinates":77},[78,79],18.95508,69.6489,{"lat":79,"lon":78},[82],{"name":83,"role":39,"phone":25,"phoneExt":25,"email":25},"Øystein Grimstad, md phd",{"facility":85,"status":49,"city":86,"state":25,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"St Olavs Hospital","Trondheim",{"type":54,"coordinates":88},[89,90],10.39506,63.43049,{"lat":90,"lon":89},[93,95,98,100],{"name":94,"role":39,"phone":25,"phoneExt":25,"email":25},"Sasha Gulati, md phd",{"name":96,"role":97,"phone":25,"phoneExt":25,"email":25},"Sozaburo Hara, md","SUB_INVESTIGATOR",{"name":99,"role":97,"phone":25,"phoneExt":25,"email":25},"Agnete M Gulati, md",{"name":101,"role":97,"phone":25,"phoneExt":25,"email":25},"Jan Jørgensen, md",{"type":103,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[105],{"name":106,"class":6},"Norwegian University of Science and Technology","100365544","spinal-cord-stimulation-for-refractory-pain-in-erythromelalgia-100365544",false,"NCT04039633","Spinal Cord Stimulation for Refractory Pain in Erythromelalgia","Inclusion Criteria:\n\n1. A diagnosis of primary or idiopathic erythromelalgia\n2. Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.\n3. Minimum pain intensity of 5\u002F10 on a numeric rating scale NRS at baseline.\n4. Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in pain NRS from baseline). This means patients will experience paresthesia during the trial period of spinal cord stimulation.\n\nExclusion Criteria:\n\n1. Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).\n2. History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.\n3. Abnormal pain behavior and\u002For unresolved psychiatric illness.\n4. Unresolved issues of secondary gain or inappropriate medication use.\n5. Unfit for participation for any other reason as judged by the study physician.","ALL","18 Years",{"count":116,"type":117},24,"ESTIMATED","INTERVENTIONAL",[120],"NA","Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.\n\nThe aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.",[123],"Erythromelalgia",[125],"Spinal Cord Stimulation","2025-07-07",{"date":128,"type":129},"2025-07-08","ACTUAL",{"date":131,"type":129},"2019-08-26",{"date":133,"type":117},"2026-01",{"name":5,"class":6},4]