ISRCTN11720855已完成未知
A multi-center prospective observational clinical study to evaluate HF10™ therapy in patients with chronic intractable predominant leg pain
evro Corp0 个研究点目标入组 90 人开始时间: 2017年2月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Predominant leg pain either idiopathic in origin or from failed back surgery syndrome which has been refractory to conservative therapy for a minimum of 3 months
- •2. Average leg pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- •3. Average leg pain intensity > average back pain intensity on the Visual Analog Scale (VAS) by 2 cm at enrollment
- •4. Neuropathic pain as clinically determined by the investigator
- •5. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the Baseline Visit
- •6. Be an appropriate candidate for HF10 therapy
- •7. At least 18 years of age at time of enrollment
- •8. Willing and capable of giving written informed consent prior to any study -related assessment
- •9. Was evaluated at the investigational site at least once prior to screen for the pain condition related to the study
- •10. Willing and able to comply with study-related requirements, assessments and visits
- •11. Capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written inform consent in English
排除标准
- •1. 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
- •2. 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 the investigator in consultation with a clinical psychologist if applicable
- •3. 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, or severe/critical spinal stenosis
- •4. A visceral pain in the area being treated
- •5. A current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- •6. A diagnosis of scoliosis that precludes lead placement
- •7. Leg pain that occurs only with weight bearing
- •8. Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain
- •9. Existing drug pump and/or SCS system or another active implantable device such as a pacemaker (switched On or Off)
- •10. Have a condition currently requiring or likely to require diathermy
- •11. Metastatic malignant disease or active local malignant disease
- •12. A life expectancy of less than 1 year
- •13. An active systemic or local infection
- •14. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- •15. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
- •16. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study
- •17. Involved in an injury claim under current litigation
- •18. A pending or approved work cover claim
研究者
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