A Post-Market Study 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
- 166
- 试验地点
- 16
- 主要终点
- Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of electrical stimulation (low levels of electricity) on low back pain. This study involves the SPRINT Peripheral Nerve Stimulation (PNS) system. The System delivers mild electrical stimulation to the nerves in the low back. The System includes up to four small wires (called "Leads") that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Chronic low back pain
排除标准
- •Infection on or around the low back
- •Conditions with increased risk of infection (e.g., valvular heart disease, compromised immune system, history of recurrent skin infections)
- •Implanted electronic device
- •Body Mass Index (BMI) > 40
结局指标
主要结局
Number of Subjects That Experienced ≥30% Reduction in Average Low Back Pain Intensity
时间窗: Baseline and End of Treatment (EOT= 8-weeks post-start of treatment)
All subjects were asked to complete daily diaries to record their average pain intensity on each day of a 7-day period. The pain intensity question was excerpted from the Brief Pain Inventory-Short Form Question 5 (BPI-5). The BPI-5 uses an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for the baseline and end of treatment (EOT) diary periods were calculated and percent reduction was determined. Subjects that achieved ≥30% reduction in pain, were considered successful.
Number of Subjects That Experienced at Least One Study-Related Adverse Event
时间窗: Up to 15 months for each subject from baseline to the last study visit
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
次要结局
- Patient Global Impression of Change (PGIC) Survey(8-weeks post-Start of Treatment (SOT))
- Mean Change in Health-Related Quality of Life(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Worst Pain Intensity(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Oswestry Disability Index (ODI)(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Pain Interference(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))
- Beck Depression Inventory (BDI-II)(Baseline and End of Treatment (EOT= 8-weeks post-start of treatment))