The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain in a Randomized, Double-blinded, Placebo-controlled, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 28
- 主要终点
- Number of Subjects That Experienced at Least One Study-Related Adverse Event
研究概览
简要总结
The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA for up to 60 days of use for the management of chronic pain, including extremity (leg) 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
- 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 old
- •Lower extremity amputation
- •Experiencing residual limb (stump) and/or phantom limb pain
- •Healed amputation and healthy residual limb based upon the investigator's evaluation
排除标准
- •Conditions with increased risk of infection (e.g., compromised immune system or history of recurrent skin infections)
- •Implanted electronic device
- •Pregnancy
结局指标
主要结局
Number of Subjects That Experienced at Least One Study-Related Adverse Event
时间窗: Up to 14 months for each Group 1 subject and up to 18 months for each Group 2 subject (time from baseline to 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 have occurred since their previous visit. If the subject experienced a change that was a study-related 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 With ≥50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])
时间窗: Baseline and 5 to 8 weeks post-start of treatment (SOT)
All subjects were asked to complete daily diaries to record their average residual limb pain and/or phantom pain intensities during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain scores were calculated across the 7-day period for each region of pain at baseline and across weeks 5 to 8 post-start of treatment. Percent reduction was then calculated for each subject's qualifying region of pain (residual limb and/or phantom limb pain with qualifying average pain intensity at baseline). To be considered a success, subjects must have experienced ≥ 50% reduction in all qualifying regions of pain compared to their 7-day baseline diary average pain score(s). The number of successes is presented.
次要结局
- Pain Medication Usage(Baseline, 1 to 4 weeks post-start of treatment (SOT), 5 to 8 weeks post-SOT, 3 months post-SOT, 6 months post-SOT, and 12 months post-SOT)
- Number of Subjects With ≥ 50% Reduction in Average Residual Limb Pain (RLP) 5 to 8 Weeks After Start of Treatment(Baseline and 5 to 8 weeks post-start of treatment (SOT))
- Number of Subjects With ≥ 50% Reduction in Average Phantom Limb Pain (PLP) 5 to 8 Weeks After Start of Treatment(Baseline and 5 to 8 weeks post-start of treatment (SOT))
- Pain Disability Index (PDI)(Visit 1 (Baseline), Visit 7 (4-weeks post-start of treatment [SOT]), Visit 11 (8-weeks post-SOT), Visit 13 (3-months post-SOT), Visit 14 (6-months post-SOT), and Visit 16 (12-months post-SOT))
- Pain Interference(Visit 1 (Baseline), Visit 7 (4-weeks post-start of treatment [SOT]), Visit 11 (8-weeks post-SOT), Visit 13 (3-months post-SOT), Visit 14 (6-months post-SOT), and Visit 16 (12-months post-SOT))
- Patient Global Impression of Change (PGIC) Survey(Visit 7 (4-weeks post-Start of Therapy [SOT]), Visit 11 (8-weeks post-SOT), Visit 13 (3-months post-SOT), Visit 14 (6-months post-SOT), and Visit 16 (12-months post-SOT))
- Durability of Treatment Effect on Average Post-Amputation Pain Intensity (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP])(Baseline, 3-months post-Start of Treatment (SOT), 6-months post-SOT, and 12-months post-SOT)
- Pain Catastrophizing Scale (PCS)(Visit 1 (Baseline), Visit 7 (4-weeks post-Start of Treatment [SOT]), and Visit 11 (8-weeks post-SOT))
- Number of Subjects With ≥ 50% Reduction in Average Post-Amputation Pain (Residual Limb Pain [RLP] and/or Phantom Limb Pain [PLP]) 1 to 4 Weeks After Start of Treatment(Baseline and 1 to 4 weeks post-start of treatment (SOT))