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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77527324

Enrollment

100

Registered

2003-07-04

Start date

2003-04-09

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Treatment A: Spinal cord stimulation using the Synergy™ Neuromodulation System (Medtronic) including trial stimulation. Patients may receive conventional treatment such as pain medication, physical th

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients reporting >50% pain relief in the legs	—

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026