A prospective, randomised, controlled, multicentre study to evaluate the effectiveness and cost-effectiveness of spinal cord stimulation using the Synergy™ System in reducing pain in patients with failed back surgery syndrome compared to conventional medical management (PROCESS study)

Medtronic Europe sarl0 个研究点目标入组 100 人开始时间: 2003年7月4日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Male/female between 18 and 65 years
•Protocol Amended 07/10/03 - Patients aged 65 and older are also included
•2. Bilateral or unilateral chronic neuropathic pain predominantly in the leg(s)(>50%)
•3. Pain radiating in dermatomo segments L4 and/or L5 and/or S1 for at least 6 months following at least one anatomically successful surgery for a herniated disc
•4. Pain intensity assessed by visual analogue scales (VAS) >5 (50%)
•5. Willing to provide informed consent

•1. Predominantly back pain (>50%)
•2. Presence of any other clinically significant or disabling chronic pain condition
•3. Expected inability of patients to receive or properly operate the spinal cord stimulation system
•4. History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
•5. Active malignancy
•6. Current use of medicines affecting coagulation which cannot be temporarily stopped
•7. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
•8. Life expectancy of less than 1 year
•9. Existing or planned pregnancy

发起方

Medtronic Europe sarl