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临床试验/ACTRN12614000684628
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。

注册库
who.int
开始日期
2014年6月27日
结束日期
待定
最后更新
6年前
研究类型
Interventional
性别
All

研究者

发起方
Saluda Medical Pty Ltd

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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