Implanted spinal neuromodulation interventions for chronic pain in adults.
Neil E O'Connell, Michael C Ferraro, William Gibson...
https://pubmed.ncbi.nlm.nih.gov/34854473Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04039633
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Led by St. Olavs Hospital · Updated on 2025-07-08
24
Participants Needed
4
Research Sites
N/A
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 condition marked by red, warm, and painful extremities, often triggered by warm environments. The exact cause is not fully understood, and managing pain is difficult since no single treatment works for everyone. This research aims to evaluate how well spinal cord stimulation works for treating pain that has not responded to other medical treatments in people with erythromelalgia. Participants will receive a spinal cord stimulator implanted, which sends electrical pulses through a thin wire to nerves near the spinal cord. The study involves four six-week periods where participants will experience either the burst spinal cord stimulation or no stimulation (sham) in a randomized order. Each participant will have two periods of actual stimulation and two periods of sham stimulation. During the study, participants will be monitored for changes in pain over six months. Researchers will also assess quality of life, disability levels, daily physical activity, redness severity, and healthcare costs. The study uses careful monitoring and randomization to compare the effects of the stimulation versus no stimulation over this time frame.
CONDITIONS
Brief Title
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary or idiopathic erythromelalgia
- Aged 18 years or older
- Chronic pain lasting 6 months or more that has not improved with medical treatment
- Pain intensity of at least 5 out of 10 on a numeric rating scale at baseline
- Completed a successful 2-week spinal cord stimulation test with at least 2 points pain reduction
You will not qualify if you...
- Conditions that increase procedural risk, such as sepsis or blood clotting problems
- History of back surgery at the thoracolumbar junction
- Abnormal pain behavior or unresolved psychiatric illness
- Unresolved issues related to secondary gain or inappropriate medication use
- Judged 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
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 24 weeks
Participants undergo implantation of a spinal cord stimulation generator and experience four six-week periods receiving either burst spinal cord stimulation or sham stimulation in a randomized order.
Regular visits during each six-week treatment period
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
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Research Team
S
Sasha Gulati, md prof
S
Sven M Carlsen, md prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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