A Randomized, Double-Blinded, Placebo-Control Multicenter Pivotal Study of the Smartpatch Peripheral Nerve Stimulation (PNS) System for the Treatment of Chronic Post-Stroke Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 5
- 主要终点
- Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
研究概览
简要总结
The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).
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
- Double (Participant, Outcomes Assessor)
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
- •Post-stroke shoulder pain
- •At least 6 months after stroke that caused shoulder pain
排除标准
- •Use of habit-forming (narcotic) medications
- •Bleeding disorder
- •History of recurrent skin infections
- •Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or Complex Regional Pain Syndrome
- •Heart arrhythmia or artificial heart valves
- •Uncontrolled seizures
- •Implanted Electronic Device
研究组 & 干预措施
Smartpatch Treatment Group
Subjects in the Treatment Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.
干预措施: Smartpatch Peripheral Nerve Stimulation (PNS) System (Device)
Smartpatch Control Group
Subjects in the Control Group will have a Smartpatch Lead placed in the shoulder, will use the Smartpatch Peripheral Nerve Stimulation (PNS) System, but will not receive any electrical stimulation.
干预措施: Smartpatch Peripheral Nerve Stimulation (PNS) System (Device)
结局指标
主要结局
Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)
时间窗: Baseline, End of Treatment (4-weeks of Treatment/Control)
A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as "please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours". BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT.
Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups
时间窗: 16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment
At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.
次要结局
- Patient Global Impression of Change at End of Treatment(End of Treatment (4-weeks of Treatment/Control))
- Change From Baseline Quality of Life at End of Treatment(Baseline, End of Treatment (4-weeks of Treatment/Control))
- Change From Baseline Shoulder Pain Interference at End of Treatment(Baseline, End of Treatment (4-weeks of Treatment/Control))
- Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment(Baseline, 12-wks post-treatment)
- Change From Baseline Average Pain Intensity at End of Treatment(Baseline, End of Treatment (4-weeks of Treatment/Control))
- Change in Pain Medication Usage at End of Treatment(End of Treatment (4-weeks of Treatment/Control))
- Clinical Global Impression of Improvement at End of Treatment(End of Treatment (4-weeks of Treatment/Control))