Spinal Cord Stimulation for Intractable Mononeuropathy

Официальное название

Spinal Cord Stimulation for Intractable Mononeuropathy: a Pilot Study

Обзор

Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the "Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients. Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done. Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre. Study population: 12 patients suffering from intractable peripheral mononeuropathic pain. Intervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months. Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.

Вмешательства

• Устройство Spinal cord stimulator
  Electrical stimulation of the dorsal horn to reduce chronic pain.

Первичные конечные точки

• Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity. [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST). [Срок оценки: 6 months]
• Effect of SCS in patients with mononeuropathy on quality of life. [Срок оценки: 6 months]
• Patient preferences for SCS paradigms as assessed by the perceived pain intensity. [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Suffering from painful intractable peripheral mononeuropathy in the distal extremities, preferably post-traumatic or post-surgical, confirmed by electromyography (EMG)
• Symptoms refractory to conventional medical management for at least 6 months according to treating physician
• 18 years or older
• Pain score on numeric rating scale (NRS) of at least 5 (average pain intensity in week prior to assessment)
• Stable or absent concomitant analgesics

Критерии исключения

• Mononeuropathy located in the head or torso
• Mononeuropathy by avulsion at the plexus brachialis
• Life expectancy <1 year
• Anticoagulant drug therapy or disturbed coagulation
• Immune-compromised patients
• Pregnancy
• Lack of cooperation of the patient or patient has a history of noncompliance with regard to (a) medical regime(s)
• Patients with psychological factors or addiction that require treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Erasmus Medical Centre — Rotterdam

Идентификаторы

NCT: NCT06546371 · MEC-2023-0644

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗