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.

none0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•Subject has been diagnosed with chronic, intractable leg and/or back pain (NPRS = 6), which has been refractory to conservative therapy for at least 6 months;
•Subject has been approved by the Investigator to undergo a trial of spinal cord stimulation;
•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 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 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 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).

发起方

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