[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467903":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":44,"locations":53,"responsibleParty":69,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":27,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":27,"enrollmentInfo":83,"targetDuration":27,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"St. Olavs Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Burst SCS","EXPERIMENTAL","Burst Spinal cord stimulation. SCS system implanted and burst stimulation given",[13,14,15],"Procedure: Burst Spinal Cord Stimulation","Procedure: Sham spinal cord stimulation","Device: SCS implant",{"label":17,"type":18,"description":19,"interventionNames":20},"Sham SCS","SHAM_COMPARATOR","Sham spinal cord stimulation. SCS system implanted but no stimulation given.",[13,14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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",[9,17],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Sham spinal cord stimulation","No spinal cord stimulation is provided",[9,17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DEVICE","SCS implant","a subcutaneously implantable pulse generator (\"pacemaker\") for long-term therapy.\n\nThe following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead",[9,17],[38,41],{"name":39,"affiliation":5,"role":40},"Sasha Gulati, md prof","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":43},"Geir Bråthen, md prof","STUDY_DIRECTOR",[45,49],{"name":39,"role":46,"phone":47,"phoneExt":27,"email":48},"CONTACT","+47 73592020","sasha.gulati@ntnu.no",{"name":50,"role":46,"phone":51,"phoneExt":27,"email":52},"Sven M Carlsen, md prof","+47 91769528","sven.carlsen@ntnu.no",[54],{"facility":55,"status":56,"city":57,"state":27,"zip":27,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"St Olavs Hospital","RECRUITING","Trondheim","Norway","NO",{"type":61,"coordinates":62},"Point",[63,64],10.39506,63.43049,{"lat":64,"lon":63},[67],{"name":68,"role":46,"phone":27,"phoneExt":27,"email":27},"Sasha Gulati, md phd",{"type":70,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[72],{"name":73,"class":6},"Norwegian University of Science and Technology","100467903","burst-crossover-trial-100467903",false,"NCT05372822","Burst Crossover Trial","Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: a Randomized Double-blind Sham-controlled Crossover Trial","Inclusion Criteria:\n\n* Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months\n* Minimum pain intensity of 5\u002F10 on the leg pain NRS at baseline\n* Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period\n* Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital\n* Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period\n\nExclusion Criteria:\n\n* Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)\n* History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.\n* Abnormal pain behavior and\u002For unresolved psychiatric illness.\n* Unresolved issues of secondary gain or inappropriate medication use.","ALL","18 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"NA","Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.\n\n'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.\n\nThe widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.\n\nThe aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.",[91,92],"Back Pain with Radiation","Pain, Postoperative",[94,95,96,97],"Lumbar Vertebrae","Surgery","Postoperational Complications","Spinal Cord Stimulation","2024-12-18",{"date":100,"type":101},"2024-12-24","ACTUAL",{"date":103,"type":101},"2021-05-01",{"date":105,"type":85},"2025-08-15",{"name":5,"class":6},1]