NCT03680846已完成不适用
A Multi-Center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-Surgical Refractory Back Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nevro Corp
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Difference between treatment groups in responder rates.
研究概览
简要总结
This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery
- •Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
- •Qualifying pain score
- •Be on stable pain medications, as determined by the Investigator
- •Be willing and capable of giving informed consent
- •Be willing and able to comply with study-related requirements, procedures, and visits
- •Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent
排除标准
- •Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
- •Have a medical condition or pain in other area(s), not intended to be treated in this study
- •Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
- •Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
- •Have any addictions as determined by the Investigator
- •Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
- •Have prior experience with neuromodulation devices
- •Other general exclusions applicable for SCS devices
- •Be involved in an injury claim under current litigation
- •Have a pending or approved worker's compensation claim
研究组 & 干预措施
CMM
Other
Conventional Medical Management
干预措施: CMM (Other)
HF10 + CMM
Active Comparator
Addition of HF10 therapy to CMM
干预措施: HF10 Therapy (Device)
HF10 + CMM
Active Comparator
Addition of HF10 therapy to CMM
干预措施: CMM (Other)
结局指标
主要结局
Difference between treatment groups in responder rates.
时间窗: 3 Months
Responder is defined as a subject who has at least 50% reduction in pain from Baseline as assessed by a 10 cm Visual Analog Scale (VAS)
次要结局
- Percentage change from baseline in back pain intensity (as assessed by VAS)(6 months)
- Change from baseline in opioid equivalent medication usage in each group(6 months)
- Change in Disability as Measured by Oswestry Disability Index(6 months)
- Neurological assessment(3, 6 and 12 months)
- Global impression of change(6 months)
- Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire(6 months)
- Incidences of adverse events(3, 6 and 12 months)
研究者
研究点 (2)
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