NCT03228420已完成不适用
A Post-Market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10™ Therapy) Combined With Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb 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
- 430
- 试验地点
- 8
- 主要终点
- Composite of Safety and Effectiveness
研究概览
简要总结
This post-market study is being conducted to document comparative safety, clinical effectiveness, and cost-effectiveness of the addition of HF10™ therapy to CMM compared with CMM alone in subjects with chronic, intractable, neuropathic lower limb pain due to diabetic neuropathy (Painful Diabetic Neuropathy or PDN). This study is a multi-center, prospective, randomized comparison of the two treatments.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower limbs.
- •Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at enrollment.
- •Have stable neurological status.
- •Be on a stable analgesic regimen.
- •Be 22 years of age or older at the time of enrollment.
- •Be an appropriate candidate for the surgical procedures required in this study.
- •Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English.
- •Be willing and capable of giving informed consent.
- •Be willing and able to comply with study-related requirements, procedures, and scheduled visits.
排除标准
- •Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.
- •Have a BMI ≥
- •Currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
- •Have a medical condition or pain in other area(s), not intended to be treated in this study.
- •Have a current diagnosis of a progressive neurological disease such a multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe spinal stenosis and brachial plexus injury.
- •Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
- •Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve stimulation (PNS) trials for chronic intractable pain.
- •Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy.
- •Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) resulting in a compromised epidural space.
- •Be benefitting from an interventional procedure and/or surgery to treat lower limb pain.
- •Have an existing drug pump and/or another active implantable device such as a pacemaker.
- •Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guidelines in the Physician's Manual.
- •Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.
- •Have a life expectancy of less than one year.
- •Have a local infection at the anticipated surgical entry site or an active systemic infection.
- •Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.
- •Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
- •Be concomitantly participating in another clinical study.
- •Be involved in an injury claim under current litigation.
- •Be a recipient of Social Security Disability Insurance (SSDI).
- •Have a pending or approved worker's compensation claim.
- •Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome.
研究组 & 干预措施
HF10 therapy plus CMM
Active Comparator
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
干预措施: Senza HF10 Therapy (Device)
CMM Alone
Other
Conventional Medical Management
干预措施: CMM (Other)
结局指标
主要结局
Composite of Safety and Effectiveness
时间窗: 3 months
Difference between treatment groups in responder rates in subjects without a clinically meaningful neurological deficit compared with baseline. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).
次要结局
- Crossover Rates(6 months)
- Neurological Assessment(6 months)
- Health-related Quality of Life(6 months)
- Responder Rates(6 months)
- Hemoglobin A1c(6 months)
- Pain Scores of 3 or Less(3 months)
- Remitter Rates(6 months)
研究者
研究点 (8)
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