[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628972":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":24,"responsibleParty":36,"collaborators":24,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":24,"enrollmentInfo":49,"targetDuration":24,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":24,"overallStatus":58,"whyStopped":24,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":24},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"paresthesia-free spinal cord stimulation (PF-SCS)","EXPERIMENTAL","At the beginning of the PF-SCS phase, the unblinded trial nurse will set the stimulator to provide active stimulation \\[500-1200 Hz at 70% of the perception amplitude - usually between 3 to 5 mA\\], which will remain constant for the 6-week duration of this period.",[13],"Device: Paresthesia-free spinal cord stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","At the beginning of the placebo phase, a trial nurse will set the stimulator to provide low-amplitude stimulation \\[500-1200 Hz at 0.1 mA, an amplitude that does not confer analgesic effects\\], which will remain constant for the 6-week duration of this period. Low-amplitude stimulation was selected as placebo to maintain participant blinding because this will mimic settings of PF-SCS on the display on the patient controller, and because it is a more acceptable control condition than no stimulation.",[13],[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DEVICE","Paresthesia-free spinal cord stimulation",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Anuj A Bhatia, MD, PhD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Emad Al Azazi, MD, PhD","CONTACT","4166035800","2508","emad.al-azazi@uhn.ca",{"type":28,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Anuj Bhatia","Professor","100628972","spinal-cord-stimulation-for-refractory-pain-randomized-controlled-trial-the-pacstim-rct-100628972",false,"NCT07468591","Spinal Cord Stimulation for Refractory Pain Randomized Controlled Trial: the PAcStim RCT","Placebo Versus Active Spinal Cord Stimulation for Refractory Pain Randomized Controlled Trial: the PAcStim RCT","PAcStim","Inclusion criteria\n\n* Age 18 years or older\n* Severe NP in the axial locations (neck and back) and\u002F or the limbs\n* Undergoing an SCS implantation with a PF device\n\nExclusion criteria\n\n* Previously implanted with an SCS device\n* Not fluent in English\n* Unable to provide written informed consent","ALL","18 Years",{"count":50,"type":51},90,"ESTIMATED","INTERVENTIONAL",[54],"NA","Neuropathic pain affects 6-10% of the global population and is poorly managed - current drug treatments succeed in only \\~25% of patients. Spinal cord stimulation (SCS) modulates pain by electrically stimulating spinal dorsal column fibres. The newer paresthesia-free mode (PF-SCS, 500-10,000 Hz) appears more effective and tolerable than traditional paresthesia-based SCS, with superior outcomes shown in the SENZA-RCT. All promising PF-SCS studies have been unblinded, making them susceptible to placebo effects. The one blinded RCT that exists had significant methodological flaws (no washout period, single baseline measurement) that biased results toward the null. A blinded, multi-centre, crossover RCT in 90 patients comparing 6 weeks of active PF-SCS vs. 6 weeks of placebo stimulation, with a 2-week washout in between - designed to correct the flaws of the prior trial and definitively establish whether PF-SCS works beyond placebo.",[57],"Chronic Pain Syndrome","NOT_YET_RECRUITING","2026-06-04",{"date":61,"type":62},"2026-06-08","ACTUAL",{"date":64,"type":51},"2026-07-01",{"date":66,"type":51},"2027-12-01",{"name":5,"class":6}]