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

Brief summary (from the registry)

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.

Study details

Official title

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

Conditions

• Chronic Pain Syndrome

Interventions

• Device: Paresthesia-free spinal cord stimulation

Sponsor

University Health Network, Toronto

Start date

2026-09-17

Primary completion

2027-10-01

Sex

All

Age range

from 18 Years

Results posted

No results posted in this snapshot

Countries

Canada

Total sites listed

1

Eligibility criteria

Canadian sites (1)