背景:脊髓损伤引起的中枢神经性疼痛是众所周知的衰弱性疼痛,目前很少有可用的治疗方法难以治疗。鞘内给药的新分子:齐科诺肽已被批准用于治疗难治性神经性疼痛。它充当突触前钙通道阻滞剂。一项初步研究显示了其在SCI神经性疼痛患者中的潜力。
目的:本研究的目的是确定慢性鞘内注射齐科诺肽治疗神经性SCI疼痛的长期(6个月)疗效。
方法:多中心,随机化,比较,安慰剂控制,双盲临床试验,随机交替6个月(安慰剂或ITZ),共15个月,包括44名患者。
方法:•各种病因的SCI患者表现出非侵入性治疗难以治疗的神经性疼痛。•>18年。
方法:通过植入泵鞘内注射齐托诺肽。
结果:主要研究结果有效治疗和安慰剂治疗期间所有患者疼痛强度的差异。次要研究结果1.持续评估疼痛强度。2.疼痛减轻至少30%的患者百分比。3.患者疼痛缓解的满意度。4.严重不良事件的声明。5.自发和引起的疼痛的持续时间和强度。6.生活质量。7.患者对变化的全球印象。8.止痛药物摄入量的每日剂量的定量。9.长期记忆和神经认知效应。10.评估患者的身体和情绪困扰。负担的性质和范围以及与参与相关的风险,有好处,和群体关系:参与这项研究符合法国目前SCI神经性疼痛的治疗方案,因此它提出了一种目前被认为是常规实践的治疗方法,即使还没有RCT证据。该研究为患者提供了直接测试与安慰剂相比的优势,否则会带来明显的限制。将创建数据安全监控板(DSMB)以进行连续安全分析。此外,患者将在专门的疼痛中心随访,提供在研究期后继续治疗的可能性.
BACKGROUND: Central neuropathic pain resulting from spinal cord injury is notoriously debilitating and difficult to treat with few currently available treatments. A novel molecule with intrathecal administration: Ziconotide has been approved for treatment of refractory neuropathic pain in general. It acts as a presynaptic calcium channel blocker. A pilot
study has shown its potential in SCI neuropathic pain patients.
OBJECTIVE: The aim of this
study is to determine the long-term (6 months) efficacy of chronic intrathecal ziconotide for the treatment of neuropathic SCI pain.
METHODS: Multicenter, Randomized, Comparative, Placebo controlled, Double blind clinical
trial, with a crossover of random alternated periods of 6 months (placebo or ITZ) for a total of 15 months including a total of 44 patients.
METHODS: • Patients with SCI of various etiologies exhibiting neuropathic pain refractory to non-invasive treatments. • > 18 years.
METHODS: Intrathecal administration of ziconotide via an implanted pump.
RESULTS: Primary study outcome Difference in pain intensity for all patients between effective treatment and placebo periods. Secondary
study outcomes 1. Continuous evaluation of pain intensity. 2. Percentage of patients with at least 30% of pain reduction. 3. Satisfaction level of the patient pain relief. 4. Declarations of serious adverse events. 5. Duration and intensity of spontaneous and provoked pain. 6. Quality of life. 7. Patient global impression of change. 8. Quantification of daily dosages of analgesic drug intake. 9. Long term memory and neurocognitive effects. 10. Assessment of the patient\'s physical and emotional distress. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study is in accordance with current treatment protocols for SCI neuropathic pain in France therefore it proposes a treatment that would currently be considered regular practice even though no RCT evidence is yet available. The
study gives patients the advantage of directly testing versus placebo a treatment that otherwise entails significant constraints. A Data Safety Monitoring board (DSMB) will be created for continuous safety analysis. Furthermore, patients will be followed in specialized pain centers offering the possibility of continuing their treatment after the study period.