NCT00991237已完成不适用
Pulsed Radiofrequency Treatment of the Lumbar Dorsal Root Ganglion for Patients With Chronic Lumbosacral Radicular Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Pain reduction
研究概览
简要总结
The purpose of the study is to evaluate the effect of PRF treatment adjacent to the lumbar dorsal root ganglion (DRG) of L5 or S1 in patients with a chronic lumbosacral radicular syndrome (LRS).
Prospective, single blinded, multicenter clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms more than 3 months 18,48
- •Optimized conventional medical management at least for 1 month
- •Pain radiating into the leg, up to the hallux (big toe) (L5) or little toe (S1)
- •The pain in the leg dominates over a possible lumbalgia, the average pain in the leg measured 3 times a day, at predefined time points, over 4 consecutive days prior to inclusion should be more than 5 (NRS 10-point scale) 8
- •Pattern of radiation suggestive for L5 or S1 pathology 49,50
- •One or more positive neurological tests of nerve root tension or neurological deficit 51 ; straight leg raising test (SLRT), contralateral SLRT, motor reaction during SLRT and passive cervical flexion, motor reaction during passive cervical flexion while bending forward in standing position
- •Capable of understanding the information relative to the treatment and procedure and willing to provide informed consent
- •Capable of understanding and filling-out the questionnaires necessary for evaluation of the treatments
- •Patients having undergone low back surgery like discectomy with or without laminectomy are allowed to participate in the study
排除标准
- •Patients younger than 18 years
- •Malignant disorder or currently under treatment for a malignant disorder
- •Previous lumbar fractures
- •Proven myelum lesion or abnormalities in the central neurological structures
- •Systemic or connective tissue diseases
- •Diabetes mellitus type I
- •Multiple sclerosis
- •Coagulation disorders
- •Pregnancy
- •Conventional medical management less then 1 month
- •Pain Catastrophizing Scale >
- •When the patient has a higher score he/she will first be referred to a psychologist for consultation 52
- •Leg pain due to localized hip or knee pathology
- •Patients with a pacemaker or neurostimulator
- •Patients previously treated with RF or PRF of the lumbar DRG
结局指标
主要结局
Pain reduction
时间窗: 2 months
次要结局
- Quality of life(2 months)
研究者
研究点 (2)
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