NCT04039633

Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia. The aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.

Conditions

• Erythromelalgia

Interventions

Type	Name	Description
PROCEDURE	Burst Spinal Cord Stimulation	Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode
PROCEDURE	Sham spinal cord stimulation	A pulse generator is implanted, but no spinal cord stimulation is provided

Timeline

• Start date: 2019-08-26
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2019-07-31
• Last updated: 2025-07-08

Locations

4 sites across 1 country: Norway