NCT05357300招募中不适用
Peripheral Nerve Stimulation for Treatment of Chronic Therapy-refractory Sacroiliac Joint Pain
PD Dr. med. Simon Bayerl2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年4月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change of chronic sacroiliac joint pain
研究概览
简要总结
Prospective randomized controlled study, primary objective: Pain reduction in patients with chronic Sacroiliac joint pain after therapy either with Peripheral Nerve Stimulation or with best medical treatment.
Randomization 4:3 to operative (PNS=Peripheral Nerve Stimulation) arm or conservative (BMT= Best Medical Treatment) arm with crossover possibility for the BMT group after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years old
- •Subject with chronic sacroiliac joint pain refractory to conservative treatment
- •Subject with NRS of at least 60/100
- •Subject with temporary pain reduction of at least 50% (NRS) after fluoroscopy guided SIJ infiltration
- •Subject received conservative treatment for at least three months including physiotherapy and pain medication
- •Subject is able to understand the study and Impulse generator programming
排除标准
- •Pregnancy
- •Subject is under age
- •Acute traumatic injury of the ISG
- •Active inflammation or neoplastic infiltration of the SIJ
- •Neoplastic diseases of the spine
- •Spinal surgery within the last three months
- •The SIJ pain is not the leading symptom
- •Contraindication for Neuromodulation Device (severe psychiatric disease, severe coagulation disorder, acute infection, active autoimmune disease with immunosupression)
结局指标
主要结局
Change of chronic sacroiliac joint pain
时间窗: 6 months
Change of pain measured with a numeric rating scale ranking from minimum 0 to maximum 100 where higher numbers mean a worse outcome
次要结局
未报告次要终点
研究者
PD Dr. med. Simon Bayerl
PD Dr. med.
Charite University, Berlin, Germany
研究点 (2)
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