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

Condition(s) studied

Investigational drug(s) / intervention(s)

Paresthesia-free spinal cord stimulation: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Evaluate the analgesic outcomes from PF-SCS against outcomes from placebo — 14-week
  PAcStim will compare the effect of 6 weeks of treatment with PF-SCS and placebo on Pain intensity, measured using the 0 to 10 pain numeric rating scale

Trial sites (1)

More University Health Network, Toronto trials in Canada

Other trials for the same condition