Spinal cord stimulation for hard-to-treat erythromelalgia pain
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
This trial will try spinal cord stimulation to see if it reduces severe, treatment-resistant pain in adults with primary erythromelalgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 4 sites (Halden and 3 other locations) |
| Trial ID | NCT04039633 on ClinicalTrials.gov |
What this trial studies
Erythromelalgia causes red, warm, painful extremities that are often resistant to medications and can severely reduce quality of life. This interventional trial compares burst-mode spinal cord stimulation with a sham stimulation in adults whose pain has remained refractory for at least six months and who succeed on a two-week tonic SCS testing period. Eligible participants must have a baseline pain score of ≥5/10 and no surgical or medical contraindications to device placement. The study measures pain outcomes to determine whether spinal cord stimulation provides meaningful relief compared with sham.
Who should consider this trial
Good fit: Adults (≥18) with primary or idiopathic erythromelalgia, chronic pain for at least six months, baseline pain ≥5/10, and a successful two-week SCS trial are the ideal candidates.
Not a fit: Patients with secondary erythromelalgia, contraindications to electrode placement (for example prior thoracolumbar fusion), unresolved psychiatric illness, or ongoing inappropriate medication use may not receive benefit or be eligible.
Why it matters
Potential benefit: If successful, spinal cord stimulation could reduce chronic refractory pain and improve daily functioning and quality of life for affected patients.
How similar studies have performed: Only case reports and anecdotal evidence have suggested benefit from spinal cord stimulation in erythromelalgia, and larger controlled trials are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A diagnosis of primary or idiopathic erythromelalgia 2. Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months. 3. Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline. 4. 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 Criteria: 1. Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy). 2. History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed. 3. Abnormal pain behavior and/or unresolved psychiatric illness. 4. Unresolved issues of secondary gain or inappropriate medication use. 5. Unfit for participation for any other reason as judged by the study physician.
Where this trial is running
Halden and 3 other locations
- Halden Dermatology Center — Halden, Norway (Recruiting)
- Aleris — Strømmen, Norway (Recruiting)
- Universitetssykehuset nord-norge hf — Tromsø, Norway (Recruiting)
- St Olavs Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Sasha Gulati, md prof — St. Olavs Hospital
- Study coordinator: Sasha Gulati, md prof
- Email: sasha.gulati@ntnu.no
- Phone: +47 73592020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.