Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System in a Randomized, Double-Blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 20
- 主要终点
- Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity
研究概览
简要总结
The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the 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 SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic 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
- •Underwent a
- •primary total knee replacement (TKR),
- •secondary/revision TKR or
- •Partial/unicompartmental knee replacement (PKR)
- •Knee pain directly resulting from Knee Replacement surgery in affected knee
排除标准
- •Current high opioid use
- •Body Mass Index (BMI) > 40 kg/m2
- •Conditions with increased risk of infection
- •Implanted electronic device
- •History of bleeding or clotting disorder.
- •Uncontrolled Diabetes Mellitus Types I or II
- •Pregnancy
结局指标
主要结局
Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity
时间窗: Baseline and 5 to 8 weeks post-Start of Treatment (SOT)
All participants were asked to complete daily diaries to record their average knee pain 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 diary(s) at baseline and across weeks 5 to 8 post-start of treatment. Percent reduction was then calculated for each participant. To be considered a success, participants must have experienced ≥ 50% reduction in average knee pain. The number of successes is presented.
Study-Related Adverse Device Effects
时间窗: Up to 13 months for each Group 1 participant and up to 16 months for Group 2 participants that opted to cross over (time from baseline to last study visit)
At each study visit following the baseline assessment at Visit 1, participants were questioned if any changes in their medical status or condition have occurred since their previous visit. If the participant experienced a change that was a study-related adverse event, an Adverse Event Form was completed by the site. The number of participants that experienced at least one study-related adverse event is reported here. Adverse Events are reported by the trial phase in which they occurred: Group 1 Treatment (active stimulation), Group 2 Control (sham stimulation), and Group 2 Crossover Safety Set (active stimulation).
次要结局
- Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity(Baseline and 1 to 4-weeks post-start of treatment (SOT))
- Pain Medication Usage(Baseline, 1 to 4 weeks post-start of treatment (SOT), and 5 to 8 weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, and 12-months post-SOT)
- Pain Catastrophizing Scale (PCS)(Baseline (Visit 1), 4-weeks post-SOT (Visit 6), and 8-weeks post-SOT (Visit 10))
- Patient Global Impression of Change (PGIC)(4-weeks post-start of treatment (SOT)(Visit 6), 8-weeks post-SOT (Visit 10), 3-months post-SOT (Visit 11), 6-months post-SOT (Visit 12), 9-months post-SOT (Visit 13), and 12-months post-SOT (Visit 14))
- Pain Interference: Number of Participants With ≥ 50% Reduction in Pain Interference(Baseline (Visit 1), 8-weeks post-start of treatment (SOT) (Visit 10), 3-months post-SOT (Visit 11), 6-months post-SOT (Visit 12), 9-months post-SOT (Visit 13), and 12-months post-SOT (Visit 14))
- Function (i.e., Physical Recovery)(Baseline (Visit 1), 8-weeks post-start of treatment (SOT) (Visit 10), 3-months post-SOT (Visit 11), 6-months post-SOT (Visit 12), 9-months post-SOT (Visit 13), and 12-months post-SOT (Visit 14))
- Long-term Durability of Average Pain Relief: Number of Participants With ≥ 50% Reduction in Average Pain Intensity(Baseline, 3-months post-start of treatment (SOT), 6-months post-SOT, 9-months post-SOT, 12-months post-SOT)
- Mean Pain Relief(Baseline, 1 to 4-weeks post-start of treatment (SOT), 5 to 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, and 12-months post-SOT)
- Six Minute Walk Test (6MWT)(Baseline (Visit 1), 8-weeks post-start of treatment (SOT) (Visit 10), and 3-months post-SOT (Visit 11))