ACTRN12614000153617已完成未知
Multi-Center, Single-Arm, Prospective Clinical Trial of the Senza Spinal Cord Stimulation (SCS) System in the Treatment of Subjects with Chronic Pain Associated with the Upper Limb and Neck
evro Corp0 个研究点目标入组 39 人开始时间: 2014年2月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain.
- •2. Considering daily activity and rest, have average upper limb or neck pain intensity of greater than or equal to 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
- •3. Be an appropriate candidate for HF10 SCS.
排除标准
- •1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study assessments , accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis and
- •fibromyalgia).
- •2. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist.
- •3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe cervical spinal stenosis and brachial plexus injury as determined by the investigator.
- •4. Having pain in the shoulder girdle or arm with a primary etiology due to a shoulder pathology.
- •5. Have a current diagnosis of a coagulation disorder, bleeding diathesis that would put patient at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease or uncontrolled diabetes mellitus.
- •6. Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention. Neurologic pathology related to severe or critical cervical spondylosis including spinal stenosis (AP diameter <10 mm), myelomalacia not related to a previously corrected stenosis, radiculopathy manifest clinically by motor deficit in setting of anatomic etiology (herniated nucleus pulposis).
- •7. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) that would disrupt/obliterate the posterior epidural space.
研究者
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