[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471622":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":37,"responsibleParty":130,"collaborators":11,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":11,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":11,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"Rijnstate Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active recharge burst stimulation","EXPERIMENTAL",null,[13],"Device: Spinal cord stimulation using active recharge burst stimulation",{"label":15,"type":10,"description":11,"interventionNames":16},"Passive recharge burst stimulation",[17],"Device: Spinal cord stimulation using passive recharge burst stimulation",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Spinal cord stimulation using passive recharge burst stimulation","Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.",[15],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Spinal cord stimulation using active recharge burst stimulation","Active recharge burst is characterized by negative pulses that directly compensate for charge differences.",[9],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Martijn Mons, Msc.","CONTACT","+31433881034","m.mons@maastrichtuniversity.nl",{"name":35,"role":31,"phone":11,"phoneExt":11,"email":36},"Jan-Willem Kallewaard, PhD","jkallewaard@rijnstate.nl",[38,54,69,83,99,115],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Arnhem","Gelderland","6815 AD","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],5.91111,51.98,{"lat":49,"lon":48},[52,53],{"name":35,"role":31,"phone":11,"phoneExt":11,"email":36},{"name":35,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":55,"status":39,"city":56,"state":57,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Bravis Hospital","Roosendaal","North Brabant","4708 AE",{"type":46,"coordinates":60},[61,62],4.46528,51.53083,{"lat":62,"lon":61},[65,68],{"name":66,"role":31,"phone":11,"phoneExt":11,"email":67},"Lars Elzinga, MD","l.elzinga@bravis.nl",{"name":66,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":70,"status":39,"city":71,"state":57,"zip":72,"country":43,"countryCode":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Elizabeth TweeSteden Hospital","Tilburg","5042 AD",{"type":46,"coordinates":74},[75,76],5.0913,51.55551,{"lat":76,"lon":75},[79,82],{"name":80,"role":31,"phone":11,"phoneExt":11,"email":81},"Jessica De Vries, MD","j.devries@etz.nl",{"name":80,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":84,"status":39,"city":85,"state":86,"zip":87,"country":43,"countryCode":44,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Amsterdam University Medical Hospitals A-UMC","Amsterdam","North Holland","1105 AZ",{"type":46,"coordinates":89},[90,91],4.88969,52.37403,{"lat":91,"lon":90},[94,96,98],{"name":95,"role":31,"phone":11,"phoneExt":11,"email":36},"Jan-Willem Kallewaard, MD",{"name":97,"role":31,"phone":11,"phoneExt":11,"email":11},"Markus Hollmann, PhD",{"name":35,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":43,"countryCode":44,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Alrijne Hospital","NOT_YET_RECRUITING","Leiderdorp","South Holland","2353 GA",{"type":46,"coordinates":106},[107,108],4.52917,52.15833,{"lat":108,"lon":107},[111,114],{"name":112,"role":31,"phone":11,"phoneExt":11,"email":113},"Katja Burger, MD","kburger@alrijne.nl",{"name":112,"role":31,"phone":11,"phoneExt":11,"email":11},{"facility":116,"status":39,"city":117,"state":118,"zip":119,"country":43,"countryCode":44,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Diakonessen Hospital","Zeist","Utrecht","3707 HL",{"type":46,"coordinates":121},[122,123],5.23333,52.09,{"lat":123,"lon":122},[126,129],{"name":127,"role":31,"phone":11,"phoneExt":11,"email":128},"Xander Zuidema, MD","xzuidema@diakhuis.nl",{"name":127,"role":31,"phone":11,"phoneExt":11,"email":11},{"type":131,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100471622","effects-of-active-versus-passive-recharge-burst-spinal-cord-stimulation-on-pain-experience-in-persistent-spinal-pain-syndrome-type-2-a-multicenter-randomized-trial-burst-rap-study-100471622",false,"NCT05421273","Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)","BURST-RAP","Inclusion Criteria:\n\n* Subjects between 18 and 70 years of age\n* At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.\n* Chronic pain diagnoses as PSPS Type 2 of at least 6 months\n* Neurologic exam without marked motor deficit.\n* LBP and\u002For leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10\n* Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria\n* Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation\n* Subject is able and willing to comply with the follow-up schedule and protocol\n* Subject is able to provide written informed consent\n\nExclusion Criteria:\n\n* Female subject of childbearing potential is pregnant\u002Fnursing or plans to become pregnant during the course of the study\n* Escalating or changing pain condition within the past month as evidenced by investigator examination\n* BMI ≥35\n* \"Subject has had injection therapy or radiofrequency treatment for their low back pain (LBP) or leg pain within the past 3 months\"\n* Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump\n* Subject is unable to operate the device\n* Severe spinal column degeneration likely to cause technical problems with neuromodulation, to be assessed by the treating physician\n* Previous Neurostimulation therapy","ALL","18 Years","70 Years",{"count":143,"type":144},96,"ESTIMATED","INTERVENTIONAL",[147],"NA","Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain",[150,151],"Persistent Spinal Pain Syndrome Type 2","Failed Back Surgery Syndrome","2024-11-15",{"date":154,"type":155},"2024-11-19","ACTUAL",{"date":157,"type":155},"2022-02-16",{"date":159,"type":144},"2026-06-30",{"name":5,"class":6},6]