Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 13
- 主要终点
- LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline
研究概览
简要总结
The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.
详细描述
This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LBP at least 6 months from original SMART Trial
- •RF Ablation Arm from SMART Trial
排除标准
- •Control Arm Subjects from SMART Trial
结局指标
主要结局
LS Mean Reduction in Oswestry Disability Index (ODI) From Baseline
时间窗: Difference between baseline and 5 year post treatment measurements
Validated questionnaire of low back pain related disability. Comprised of 10 questions evaluating the impact of low back pain on activities of daily living. The ODI is scored 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). Difference in mean ODI at baseline and 5 years post treatment measurements.
次要结局
- LS Mean Reduction in VAS From Baseline(Difference between baseline and 5 year post treatment measurements)
- Responder Rates(At 5 year post treatment)
- Narcotics Use(Difference between baseline and 5 years post treatment.)
- Injections(Difference from baseline percentage measurement to 5 years post treatment measurement)
- Interventions(Measured form treatment data to 5 years post treatment visit date)