A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 34
- 主要终点
- Study-Related Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic low back pain
排除标准
- •Body Mass Index (BMI) > 40
- •Prior lumbar surgery
- •Implanted electronic device
研究组 & 干预措施
Group 1: Peripheral Nerve Stimulation (PNS)
Subjects in Group 1 will have leads placed in their lower back. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
干预措施: SPRINT Peripheral Nerve Stimulation (PNS) System (Device)
Group 2: Standard Interventional Management (Standard of Care)
Subjects in Group 2 will receive the standard of care. Group 2 subjects may be able to crossover to receive PNS after 12 months from start of treatment (Visit 16).
干预措施: Standard interventional management of low back pain (Procedure)
结局指标
主要结局
Study-Related Adverse Events (AEs)
时间窗: 24-months post-SOT
Occurrence and type of study-related AEs
Reduction in average pain intensity
时间窗: Up to 3-months after Start of Therapy (SOT)
Average pain is measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
Study-Related Adverse Events (AEs)
时间窗: During the Medial Branch Block procedure
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: During the Lead Placement procedure (SOT)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 1-week post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 2-weeks post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 3-weeks post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 4-weeks post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 5-weeks post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 6-weeks post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 7-weeks post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 8-weeks post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 3-months post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 6-months post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 9-months post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 12-months post-SOT
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
时间窗: 18-months post-SOT
Occurrence and type of study-related AEs
次要结局
- Patient Global Impression of Change(3-months after SOT)
- Reduction in pain interference(Baseline, 3-months after SOT)
- Durability of reductions in pain intensity(Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT)
- Reduction in disability(Baseline, 3-months after SOT)
- Reduction in worst pain intensity(Baseline, 3-months after SOT)
- Change in health-related quality of life(Baseline, 3-months after SOT)
- Change in analgesic medication usage(Baseline, 3-months after SOT)