Spinal Cord Stimulation for Refractory Pain in Erythromelalgia

Обзор

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.

Вмешательства

• Процедура 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
• Процедура Sham spinal cord stimulation
  A pulse generator is implanted, but no spinal cord stimulation is provided

Первичные конечные точки

• Changes in pain [Срок оценки: 6 months]

Вторичные конечные точки (5)

• Change in generic health-related quality of life [Срок оценки: 6 months]
• Oswestry disability index (ODI) score [Срок оценки: 6 months]
• Daily physical activity [Срок оценки: 6 months]
• Severity of erythema [Срок оценки: 6 months]
• Health Care Provider's Costs [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Норвегия · 4 центра

• Halden Dermatology Center — Halden
• Aleris — Strømmen
• Universitetssykehuset nord-norge hf — Tromsø
• St Olavs Hospital — Trondheim

Публикации

• 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

Идентификаторы

NCT: NCT04039633 · 2019/159

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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