Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- VAS-Visual Analog Scale- score of combined back and leg pain at 6 weeks follow-up.
研究概览
简要总结
The specific aims of this proposal are to:
Examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. The primary outcome will be improvement in VAS score of combined back and leg pain at 6 weeks follow-up. Secondary outcomes will include improvement in Visual Analog Scale (VAS) back pain scores, VAS leg pain scores, and Oswestry Disability Index (ODI) , as well as SCS complication rate.
The specific aims of this proposal are to:
Examining the effects of dorsal column stimulation on pain from lumbar spinal stenosis related to lumbar epidural lipomatosis. The primary outcome will be improvement in VAS score of combined back and leg pain at 6 weeks follow-up. Secondary outcomes will include improvement in VAS back pain scores, VAS leg pain scores, and Oswestry Disability Index, as well as SCS complication rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Have chronic pain for >3 months
- •Age 18-65 years
- •Have been scheduled to be implanted with the spinal cord stimulator due to epidural lipomatosis.
- •MRI evidence of lumbar spinal stenosis with grade I-III Lumbar epidural lipomatosis and concordant history and physical examination
排除标准
- •No evidence of lumbar epidural lipomatosis based on MRI
- •Presence of a pacemaker/ICD (to avoid possible side-effects of electrical stimulation)
- •Coagulopathy (either non-pharmacological or unable to discontinue anticoagulation due to underlying comorbidities as deemed by prescribing physician)
- •Unable to follow commands or provide consent.
- •Are not medically/psychologically stable
- •Have clinical/EMG documented motor dysfunction and have not been evaluated by spine surgeon.
- •Inappropriate surgical candidates as determined by the individual implanting physician.
- •History of laminectomy/fusion in thoracic or lumbar spine.
结局指标
主要结局
VAS-Visual Analog Scale- score of combined back and leg pain at 6 weeks follow-up.
时间窗: 6 weeks
0 meaning No Pain, 10 being worst possible pain. Higher pain means worse outcome.
次要结局
- Change in VAS-Visual Analog Scale- score of low back pain.(6 months, 12 months)
- Change in VAS-Visual Analog Scale - score of leg pain score(6 months, 12 months)
- Change in Oswestry Disability Index.(6 weeks, 6 months, 12 months)
研究者
Salim M Hayek
MD/PI
University Hospitals Cleveland Medical Center