NL-OMON54096已完成不适用
A prospective, randomised, double-arm, open label exploratory trial to investigate patient and physician experiences of spinal or local anaesthesia and its influence on ECAPs during SCS trial lead implantation. - SPILOCAP study
Elisabeth-Tweesteden ziekenhuis0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Subject has been diagnosed with chronic, intractable leg and/or back pain
- •(NPRS >= 6), FBSS, which has been refractory to conservative therapy for at
- •least 6 months.
- •Subject has been approved by the Investigator to undergo a trial of SCS
- •implantation.
- •Subject is an appropriate candidate for the surgical procedures required for
- •SCS based on the clinical judgment of the implanting physician.
- •Subject is on a stable dose (no new, discontinued, or changes in dose) of all
- •prescribed pain medication for at least 30 days prior to baseline evaluation.
- •Subject is willing and capable of giving written informed consent.
- •Subject is willing and able to comply with study-related requirements,
- •procedures, and visits.
- •Subject is at least 18 years of age
排除标准
- •Subject has 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.
- •Subject is not an SCS candidate due to anatomical or structural findings
- •and/or changes which would benefit from surgical intervention as determined by
- •the Investigator.
- •Subject has evidence of an active disruptive psychological or psychiatric
- •disorder or other known condition significant enough to impact perception of
- •pain, compliance with intervention and/or ability to evaluate treatment
- •outcomes as determined by the Investigator.
- •Subject who has had another neuromodulation system.
- •Subject has a condition currently requiring or likely to require the use of
- •MRI or diathermy.
- •Subject is not a good surgical candidate (e.g., has an uncontrolled
- •coagulation disorder, bleeding diathesis, progressive peripheral vascular
- •disease, uncontrolled diabetes mellitus, or cannot come off anticoagulant
- •therapy for procedure).
- •Subject is concomitantly participating in another clinical study unless
- •pre-approved by the principal investigator.
- •Subject is involved in a process (e.g., involved in an injury claim under
- •current litigation) in which pain relief may be considered detrimental (i.e.,
- •secondary gains).
研究者
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