Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Erythromelalgia

In brief

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 facts

Study ID

NCT04039633

Run by

St. Olavs Hospital

People needed

24

Starts

2019-08-26

Expected to finish

2026-01-01

Last updated by the study team

2025-07-08

Who can join

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

You may qualify if…

• A diagnosis of primary or idiopathic erythromelalgia
• Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.
• Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline.
• Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in pain NRS from baseline). This means patients will experience paresthesia during the trial period of spinal cord stimulation.

You may not qualify if…

• Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).
• History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
• Abnormal pain behavior and/or unresolved psychiatric illness.
• Unresolved issues of secondary gain or inappropriate medication use.
• Unfit for participation for any other reason as judged by the study physician.

Where it is running

• Halden Dermatology Center — Halden, Norway (enrolling)
• Aleris — Strømmen, Norway (enrolling)
• Universitetssykehuset nord-norge hf — Tromsø, Norway (enrolling)
• St Olavs Hospital — Trondheim, Norway (enrolling)

Full record on ClinicalTrials.gov

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