INTRACEPT: A Prospective, Randomized, Multi-Center Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 36
- 主要终点
- Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
研究概览
简要总结
Prospective, open-label, 1:1 randomized controlled trial of Basivertebral nerve (BVN) Ablation arm vs Standard Care Control for the treatment of vertebrogenic chronic low back pain (CLBP). Participants in the the BVN Ablation arm will receive radiofrequency ablation of the BVN using the Intracept procedure for treatment of up to 4 vertebral bodies (L3 to S1). Participants in the Standard Care Control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment.
The study had a pre-specified Interim Analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. An independent Data Safety Management Board (DSMB) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.
详细描述
Participants in the BVN Ablation arm will be followed for 24 months following treatment. BVN Ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up).
Control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the DSMB recommendation at a mean of 176.5 days.
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
- 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
- 否
入选标准
- •Skeletally mature subjects at least 25 years of age
- •Chronic lower back pain for at least 6 months
- •Failure to respond to at least 6 months of non-operative conservative management
排除标准
- •Radicular pain
- •Current or history of spinal infection
- •Modic changes at vertebral bodies other than L3 to S1
- •Contraindication to MRI
- •Pregnant, lactating or plan to become pregnant in next year
- •Has life expectancy of less than 2 years
- •Compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
结局指标
主要结局
Difference Between Arms in Least Squared (LS) Mean Change in Oswestry Disability Index (ODI)
时间窗: 3 months
Difference between arms in LS Mean change in ODI (baseline to 3 months post-treatment). ODI is measured on a scale of 0 (no disability) to 100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The minimally clinically important difference for this tool is considered to be a 10 point reduction in ODI from a baseline in a patient. These data are for interim analysis of the primary endpoint. Data for later time points will be included in the current Outcome Measures as additional Rows, once available.
次要结局
- Difference Between Arms in LS Mean Change in Visual Analog Scale (VAS)(3 months post treatment / randomization)