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RECRUITING
NCT04039633
NA

Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Sponsor: St. Olavs Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2019-08-26

Completion Date

2026-01

Last Updated

2025-07-08

Healthy Volunteers

No

Conditions

Interventions

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

Locations (4)

Halden Dermatology Center

Halden, Norway

Aleris

Strømmen, Norway

Universitetssykehuset nord-norge hf

Tromsø, Norway

St Olavs Hospital

Trondheim, Norway