SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 137
- 试验地点
- 53
- 主要终点
- Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation [PNS]) in the reduction of chronic, intractable post-surgical back pain in adults.
详细描述
This study is a multi-center, prospective, randomized (1:1) parallel-group design.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have persistent back pain for at least 6 months
- •Had back surgery at least 6 months ago
- •Have tried pain medications and physical therapy
- •Read and understand written English or Spanish
- •Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation
- •Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements
- •Have an expected lifespan greater than 12 months
排除标准
- •Have leg pain in addition to back pain.
- •Currently enrolled in or plan to enroll in another drug and/or device study
- •Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia
- •Have an active systemic infection or are immunocompromised
- •Will be exposed to diathermy or anticipate needing a full-body MRI scan
- •Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator
- •Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery
研究组 & 干预措施
Treatment
Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant
干预措施: PrimeAdvanced® neurostimulator system (Device)
Control
Control settings of Medtronic PrimeAdvanced® neurostimulator system implant
干预措施: PrimeAdvanced® neurostimulator system (Device)
结局指标
主要结局
Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.
时间窗: Baseline to 3 months
Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.
次要结局
- Subject Satisfaction(3 months)
- Worst Back Pain(Baseline to 3 months)
- Quality of Life: Physical(Baseline to 3 months)
- Functional Disability(Baseline to 3 months)
- Quality of Life: Mental(Baseline to 3 months)