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Идёт набор NCT05372822

Burst Crossover Trial

Без фазы С лечением Back Pain with Radiation Pain, Postoperative

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Burst Spinal Cord Stimulation, Sham spinal cord stimulation, SCS implant.
Кому может быть актуально
Состояния в реестре: Back Pain with Radiation, Pain, Postoperative. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
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Официальное название

Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: a Randomized Double-blind Sham-controlled Crossover Trial

Обзор

Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant. 'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation. The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation. The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.

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
    No spinal cord stimulation is provided
  • Устройство SCS implant
    a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy. The following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead

Первичные конечные точки

  • change in disease-specific functional outcome from baseline [Срок оценки: 12 months]
Вторичные конечные точки (5)
  • Change in generic health-related quality of life measured with the Euro-Qol-5D (5L) [Срок оценки: 12 months]
  • Change in back pain [Срок оценки: 12 months]
  • change in leg pain [Срок оценки: 12 months]
  • Daily physical activity [Срок оценки: 12 months]
  • Six-month follow-up of pain-related disability [Срок оценки: 18 months]

Критерии участия

Критерии включения

  • Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
  • Minimum pain intensity of 5/10 on the leg pain NRS at baseline
  • Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
  • Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital
  • Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period

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.

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 · 1 центр
  • St Olavs Hospital — Trondheim

Идентификаторы

NCT: NCT05372822 · 2018/475-b

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗