Can a nerve stimulator turn down the fire of erythromelalgia?
NCT ID NCT04039633
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial tests whether spinal cord stimulation can reduce severe, treatment-resistant pain in people with erythromelalgia, a rare condition causing red, hot, and painful extremities. Participants receive either burst stimulation or sham (inactive) stimulation to see if the therapy truly helps. The study measures changes in pain scores and quality of life, aiming to provide evidence for a condition with few effective options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Spinal cord stimulation (burst mode) compared to sham stimulation
- What this could lead to
- If effective, this could offer a new treatment option for people with erythromelalgia whose pain does not respond to medication, potentially improving their quality of life.
- What could go wrong
- This is a very small early trial (6 participants), so results may not apply broadly. The procedure is invasive and carries risks like infection or lead migration, and the sham comparison helps check if pain relief is real or a placebo effect.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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6 people
The number who actually took part.
- Started
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Aug 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Aleris
Strømmen, Norway
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Halden Dermatology Center
Halden, Norway
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St Olavs Hospital
Trondheim, Norway
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Universitetssykehuset nord-norge hf
Tromsø, Norway
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