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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Chronic Pain Syndrome

In brief

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.

Key facts

Study ID

NCT07468591

Run by

University Health Network, Toronto

People needed

90

Starts

2026-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older
• Severe NP in the axial locations (neck and back) and/ or the limbs
• Undergoing an SCS implantation with a PF device

You may not qualify if…

• Previously implanted with an SCS device
• Not fluent in English
• Unable to provide written informed consent

Full record on ClinicalTrials.gov

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