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)

Completed

• Conditions: Failed Back Surgery Syndrome (FBSS), chronic neurophatic pain; Musculoskeletal Diseases; Pain, not elsewhere classified

• Registration Number: ISRCTN77527324
• Lead Sponsor: Medtronic Europe sarl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients reporting >50% pain relief in the legs

Secondary Outcome Measures

Name	Time	Method
Pain relief, health-related quality of life (SF-36 and EQ-5D), functional capacity (Oswestry), patient satisfaction, time away from work, adverse events