跳至主要内容
临床试验/NCT02128672
NCT02128672撤回不适用

Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study

Mayo Clinic0 个研究点开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Mayo Clinic
主要终点
Did the participant have paresthesia coverage from the stimulation?

研究概览

简要总结

Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back.

This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • •Patients with one sided low back pain
  • •Failed standard conservative care including medications, physical therapy, and/or injections
  • •Pain greater than 6 months

排除标准

  • •Pregnancy
  • •Previous spine surgery
  • •Pain radiating beyond/below the knee

研究组 & 干预措施

Conventional SCS lead

Active Comparator

Conventional Thoracic-lumbar SCS lead placement

干预措施: Spinal Cord Stimulator Lead Placement (Procedure)

SCS Experimental Lead Placement

Experimental

Experimental SCS lead placement in a novel position

干预措施: Spinal Cord Stimulator Lead Placement (Procedure)

结局指标

主要结局

Did the participant have paresthesia coverage from the stimulation?

时间窗: Baseline to 4 days

This is a simple yes or no outcome. Either the patient is able to feel the stimulation paresthesia in the area of his or her back where he or she has pain (outcome is yes) or they do not feel it (outcome is no).

次要结局

  • Numeric Pain Rating Scale (NRS)(Baseline to 4 days)
  • Patient preferred stimulation-Likert Scale(baseline to 4 days)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tim J. Lamer, M.D.

Associate Professor of Anesthesiology

Mayo Clinic

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