Status:
RECRUITING
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Erythromelalgia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04039633
Start Date
August 26 2019
End Date
January 1 2026
Last Update
July 8 2025
Active Locations (4)
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1
Halden Dermatology Center
Halden, Norway
2
Aleris
Strømmen, Norway
3
Universitetssykehuset nord-norge hf
Tromsø, Norway
4
St Olavs Hospital
Trondheim, Norway