High Density Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain Patients: A Prospective Multicenter Randomized Controlled, Double-blind, Crossover Exploratory Study with 6-m Open Follow-up

Seoul National University Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•(1)Patients with chronic intractable pain who meets the Korean SCS Reimbursement Guideline as follows:
•(Korea SCS Reimbursement Guideline)
•a)An ineffective patient with sustainable severe intractable pain (VAS or NRS pain score over 7 grade) who has been treated by a conservative therapy (medication and nerve block, etc.) for 6 months.
•cf.) CRPS is available after the conservative therapy for 3 months
•b)An ineffective cancer pain patient with over 1 year life expectancy and VAS (or NRS pain score) over 7 grade who takes active pain treatment for 6 months such as medication, nerve block, epidural morphine injection, etc.
•(2)Age > 18
•(3)Patients who have been informed of the study procedures and has given written informed consent.
•(4)Patients who are willing to comply with study protocol including attending the study visits

•(1)Expected inability of patients to receive or properly operate the SCS system
•(2)Active malignancy
•(3)Addiction to any of the following drugs, alcohol, and/or medication
•(4)Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
•(5)Local infection or other skin disorder at site of incision
•(6)Pregnancy
•(7)Other implanted active medical device
•(8)Life expectancy < 1 year
•(9)Coagulation deficiency (Platelet count < 100,000, PT INR > 1.4)
•(10)Immune deficiency (HIV positive, immunosuppressive, etc.)

发起方