A Multicentre Prospective Observational Study on the Safety and Efficacy of High Frequency Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients

evro Corporation0 个研究点目标入组 50 人开始时间: 2012年3月27日最近更新: 2020年1月13日

试验速览

暂无简介。

•Diagnosed with CRPS according to the Budapest research diagnostic criteria
•Symptoms for more than 6 months and less than 5 years
•Failed conservative management for 3 months
•Average pain intensity of at least 5cm out of 10cm in the 30 days prior to the Baseline Visit (based on the baseline visit VAS)
•Over 18 years of age
•Able to provide informed consent and willing to comply with study procedures

•Contra-indication to the implantation of an SCS system
•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
•Have a 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, or severe/critical spinal stenosis
•Evidence of an active disruptive 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 a psychiatrist
•Female patients that are pregnant or are planning to become pregnant over the next 12 months
•Life expectancy of lesss than 1 year
•Inability to manage the technical demands of the SCS equipment

发起方

evro Corporation