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 sites100 target enrollmentJuly 4, 2003

Overview

No summary available.

Registry

who.int

Start Date

July 4, 2003

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Medtronic Europe sarl

•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