ISRCTN11735894进行中（未招募）未知
A Prospective Post-market Study to Investigate the Effect of HF10™ Therapy on Opioid Analgesic Use for the Treatment of Chronic Intractable Low Back and/or Radicular Leg Pain
evro Corp0 个研究点目标入组 49 人开始时间: 2018年10月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
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. Diagnosed with chronic intractable back and/or leg pain
- •2. 18 years of age or older at time of enrolment
- •3. Currently taking opioids within a dose range of 15-100 mg/day oral morphine or the equivalent (MEDD)
- •4. Average back or leg pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrolment
- •5. Meet the requirements for being an HF10 Therapy trial candidate as per the centers’ practice, which includes psychological evaluation
- •6. Willing and able to complete health questionnaires and pain scales as specified in the protocol
排除标准
- •1. Plans to enrol in another clinical study during their participation in this study, or are currently enrolled in an interventional clinical study that could interfere in participation in this study or affect the scientific soundness of this study
- •2. Medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia)
- •3. Current addiction to cocaine, opiates, alcohol, or benzodiazepines as determined by the treating physician
- •4. 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 either the treating physician or a psychologist
- •5. 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, and/or central deafferentation syndrome
- •6. Current diagnosis of a coagulation disorder, bleeding diathesis that would put subject at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease, or uncontrolled diabetes mellitus
- •7. Diagnosis of scoliosis that precludes lead placement
- •8. Condition currently requiring or likely to require the use of diathermy
- •9. Metastatic malignant disease or active local malignant disease
- •10. Life expectancy of less than 1 year
- •11. Active systemic or local infection
- •12. 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)
研究者
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