A Prospective Multi-Center Pilot Study of the SPR™ System for the Treatment of Post-Stroke Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 7
- 主要终点
- Pain Intensity (Trial Stage)
研究概览
简要总结
Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain.
Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.
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
- Single (Participant)
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
- •Trial Stage
排除标准
- •Use of habit-forming (narcotic) medications
- •History of recurrent skin infections
- •Bleeding disorder
- •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
- •Implant Stage Inclusion Criteria
- •Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4
研究组 & 干预措施
The SPR System
The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.
干预措施: The SPR System (Device)
结局指标
主要结局
Pain Intensity (Trial Stage)
时间窗: Baseline, 3-week (Trial Stage), 6-week (Trial Stage)
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).
Pain Intensity (Implant Stage)
时间窗: 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)
Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON.
Device-Related Adverse Events
时间窗: Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had 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.
Number of Subjects Who Were a Trial Stage Success
时间窗: End of Treatment (EOT)
The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.
Number of Subjects Who Were an Implant Stage Success
时间窗: 12-weeks post IPG-Stim ON
Number of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.
次要结局
- Pain Interference (Implant Stage)(3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage))
- Pain-Free Passive Range of Motion (Trial Stage)(Baseline, 3-week (Trial Stage), 6-week (Trial Stage);)
- Pain Interference (Trial Stage)(Baseline, 3-week (Trial Stage), 6-week (Trial Stage))
- Number of Participants Completing the Economic Impact Survey(Baseline)
- Pain-Free Passive Range of Motion (Implant Stage)(3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage))
- Emotional Functioning (Trial Stage)(Baseline, 3-week (Trial Stage), 6-week (Trial Stage))
- Global Impact of Stimulation Therapy (Trial Stage)(3-week (Trial Stage), 6-week (Trial Stage))
- Quality of Life (Implant Stage)(3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage))
- Global Impact of Stimulation Therapy (Implant Stage)(3-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36-months Post IPG-Stim ON (Implant Stage))
- Reduction in Arm Impairment and Improvement in Activities of Daily Living (Trial Stage)(Baseline, 3-week (Trial Stage), 6-week (Trial Stage))
- Quality of Life (Trial Stage)(Baseline, 3-week (Trial Stage), 6-week (Trial Stage))
- User Satisfaction (Trial Stage)(6-week (Trial Stage))
- User Satisfaction (Implant Stage)(12-weeks,12-months post IPG-Stim ON (Implant Stage))
- Emotional Functioning (Implant Stage)(3-weeks, 12-weeks, 6-months, 9-months, 12-months post IPG-Stim ON (Implant Stage))