Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Burst Spinal Cord Stimulation, Sham spinal cord stimulation.
- Who it may be relevant to
- Registry conditions: Erythromelalgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Burst Spinal Cord Stimulation
Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode - Procedure Sham spinal cord stimulation
A pulse generator is implanted, but no spinal cord stimulation is provided
Primary outcome measures
- Changes in pain [Time frame: 6 months]
Secondary outcome measures (5)
- Change in generic health-related quality of life [Time frame: 6 months]
- Oswestry disability index (ODI) score [Time frame: 6 months]
- Daily physical activity [Time frame: 6 months]
- Severity of erythema [Time frame: 6 months]
- Health Care Provider's Costs [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Norway · 4 centers
- Halden Dermatology Center — Halden
- Aleris — Strømmen
- Universitetssykehuset nord-norge hf — Tromsø
- St Olavs Hospital — Trondheim
Publications
- O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2. PMID 34854473
Identifiers
NCT: NCT04039633 · 2019/159