Spinal Cord Stimulation for Refractory Pain Randomized Controlled Trial: the PAcStim RCT

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.

NCT Number	NCT07468591
Lead Sponsor	University Health Network, Toronto
Conditions	Chronic Pain Syndrome
Enrollment	90 participants
Start Date	2026-07-01
Primary Completion	2027-06-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-08