ACTRN12614000684628
已完成
未知
Effectiveness of feedback control on neural stimulation in patients with chronic pain with regard to pain relief and stimulation side effects in an extended trial
Saluda Medical Pty Ltd0 个研究点目标入组 25 人2014年6月27日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Chronic pain
- 发起方
- Saluda Medical Pty Ltd
- 入组人数
- 25
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Patients enrolled in this study must meet the following inclusion criteria:
- •1\.Have been diagnosed with chronic, intractable pain, which has been refractory to conservative therapy for a minimum of 3 months.
- •2\.Have been approved to undergo a trial of neural stimulation. Neural stimulation can include spinal cord stimulation (cervical, thoracic or sacral), peripheral nerve stimulation (such as occipital or sacral nerves), dorsal root, or dorsal root ganglion.
- •3\.Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- •4\.Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
- •5\.Be 18 years of age or older at the time of enrolment
- •6\.Be willing and capable of giving written informed consent
- •7\.Be willing and able to comply with study\-related requirements, procedures, and visits.
排除标准
- •Patients enrolled in this study must not meet the following exclusion criteria:
- •1\.Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •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 outcomes
- •3\.Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- •4\.Have a diagnosis of scoliosis that precludes lead placement in epidural space (for SCS patients only)
- •5\.Have an existing drug pump and/or neural stimulation system or another active implantable device such as a pacemaker
- •6\.Have a condition currently requiring or likely to require the use of MRI or diathermy
- •7\.Have pain due to a malignant disease
- •8\.Have a life expectancy of less than 1 year
- •9\.Have an active systemic or local infection
结局指标
主要结局
未指定
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