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

Study acronym: PAcStim
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jun 1, 2027 → Oct 1, 2027
See other at-risk trials from University Health Network, Toronto

Record History

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Primary completion pushed from Jun 1, 2027 to Oct 1, 2027 · Study sites: 0 to 1 · Start date changed from estimate of Jul 1, 2026 to Sep 17, 2026 · 2 more Show 5 more changesShow less
    • Primary completion pushed from Jun 1, 2027 to Oct 1, 2027
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2026 to Sep 17, 2026
    • Eligibility criteria expanded, about 6 words
    • Study description revised
  2. Primary completion pushed from Dec 1, 2026 to Jun 1, 2027 Start date: Apr 1, 2026 to Jul 1, 2026 · Completion pushed from Apr 1, 2027 to Dec 1, 2027v2 Show 2 more changesShow less
    • Start date: Apr 1, 2026 to Jul 1, 2026
    • Completion pushed from Apr 1, 2027 to Dec 1, 2027
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07468591
Lead Sponsor University Health Network, Toronto
Conditions Chronic Pain Syndrome
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov