NCT03630133撤回不适用
A Prospective, Open-Label, Single-Arm, Single-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
Objective of study is to evaluate the procedural success rate, clinical effectiveness, and heath-economic profile using the Intercept Intraosseous Nerve Ablation System in adult subjects with chronic low back pain in the post-market setting
详细描述
This is a prospective, open-label, single-arm, single-center study. There is no randomization or blinding. Subjects will receive the Intercept System procedure to treat one or two motion segments at L3/L4, L4/L5, or L5/S1 as identified by Modic Type 1 or 2 changes.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Skeletally mature subjects age 25-70 years, inclusive
- •Chronic lower back pain for at least six months
- •Failure to respond to at least six months of non-operative conservative management
- •Oswestry Disability Index (ODI) at time of evaluation of at least 30 points
- •Modic changes (Type 1 or 2) in at least one vertebral endplate, at one or more levels from L3 to S1
排除标准
- •Radicular pain by history or evidence of pain neurological deficit within the past one year.
- •Previous surgery performed on the lumbar spine
- •Current or history of symptomatic spinal stenosis
- •Current or history of osteoporotic or tumor-related vertebral body compression fracture
- •Current or history of vertebral cancer or spinal metastasis
- •Current or history of spinal infection
- •Metabolic bone disease
- •BMI greater or equal to 40
- •Any radiographic evidence of other important back pathology
- •MRI evidence of Modic changes, Type 1 or 2 at greater than 3 vertebral bodies or at non-consecutive levels, or at vertebral bodies other than L3 to S1
- •Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
- •Subjects who are bed bound
- •Demonstrates 3 or more Waddell's signs of Inorganic Behavior
- •Any evidence of current systemic infection
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 3 months
Mean change in Oswestry Disability Index Score from baseline to 3 months post-treatment. Scale is measured from 0 to 100, better to worse respectively.
次要结局
- Oswestry Disability Index (ODI)(6, 9, and 12 months)
- Visual Analog Scale (VAS)(3, 6, 9, and 12 months)
研究者
研究点 (2)
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