Actively Recruiting
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Led by St. Olavs Hospital · Updated on 2025-07-08
24
Participants Needed
4
Research Sites
331 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
N
Norwegian University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary or idiopathic erythromelalgia
- Age 18 years or older
- Chronic pain lasting 6 months or more that has not improved with medical treatment
- Minimum pain intensity of 5 out of 10 on a numeric rating scale at baseline
- Successful two-week spinal cord stimulation trial with tonic stimulation showing at least 2 points reduction in pain
You will not qualify if you...
- Conditions increasing procedural risk such as sepsis or coagulopathy
- History of laminectomy or posterior fusion at the thoracolumbar junction
- Abnormal pain behavior or unresolved psychiatric illness
- Unresolved secondary gain issues or inappropriate medication use
- Deemed unfit for participation by the study physician for any other reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Halden Dermatology Center
Halden, Norway
Actively Recruiting
2
Aleris
Strømmen, Norway
Actively Recruiting
3
Universitetssykehuset nord-norge hf
Tromsø, Norway
Actively Recruiting
4
St Olavs Hospital
Trondheim, Norway
Actively Recruiting
Research Team
S
Sasha Gulati, md prof
CONTACT
S
Sven M Carlsen, md prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here