Related Experiment Video
Updated: May 26, 2026
Treating Low Back Pain in Failed Back Surgery Patients with Multicolumn-lead Spinal Cord Stimulation
Published on: June 26, 2018
Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective, Randomized, Controlled, Multicenter Study
Krishna Kumar1, Richard North, Rod Taylor
1Department of Neurosurgery Regina General Hospital, Regina, Saskatchewan, Canada; Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Department of Public Health and Epidemiology, University of Birmingham, Edgbaston, Birmingham, UK; Centre for Health Economics, University of York, York, UK; Medtronic Europe Sàrl, Route de Molliau, Tolochenaz, Switzerland; Department of Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada; Department of Pain & Anaesthesia, James Cook University Hospital, Middlesbrough, Cleveland, UK; Institute of Neurosurgery, Catholic University of Rome, Rome, Italy; Department of Neurosurgery, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain; Pain Management Clinic, Basildon and Thurrock University Hospitals, Basildon, Essex, UK; Pain Clinic, Axxon Pain Medicine, Brisbane, Queensland, Australia; Pain Relief Unit, Rambam Medical Center, Haifa, Israel; Department of Neurosurgery, Centre Hospitalier Régional de Namur (CHR Namur), Namur, Belgium; Pain Management Department, Varese Regional Hospital and Macchi Foundation, Varese, Italy; Department of Pain and Anesthesia, Bradford Hospitals, Bradford, UK; and Anesthesia and Pain Management Services, Center for Neuromodulation EHC, Hospital of Morges, Morges, Switzerland, [ISRCTN77527324].
Spinal cord stimulation (SCS) is being evaluated for failed back surgery syndrome (FBSS) in a large trial. This study assesses if SCS improves pain relief and is cost-effective compared to standard care.
Area of Science:
- Neurology
- Pain Management
- Clinical Trials
Background:
- Spinal cord stimulation (SCS) has shown promise for failed back surgery syndrome (FBSS) management in case series.
- Limited randomized controlled trials exist, with only one demonstrating SCS superiority over re-operation and conventional medical management.
Purpose of the Study:
- To assess the clinical effectiveness and cost-effectiveness of SCS as an adjunct to conventional medical management for FBSS.
- To compare SCS plus conventional medical management against conventional medical management alone in FBSS patients.
Main Methods:
- A prospective, randomized, controlled, multicenter trial involving 100 FBSS patients with neuropathic leg pain.
- Patients randomized to SCS plus conventional medical management or conventional medical management alone for 24 months.
- Outcomes assessed at multiple time points, with a 6-month success classification and option for crossover.
Main Results:
- Study is ongoing; results are not yet available.
- The trial is designed to provide conclusive evidence on SCS efficacy and cost-effectiveness.
- Patient outcomes will be evaluated based on pain relief and other clinical measures.
Conclusions:
- This trial aims to provide definitive evidence for SCS in FBSS management.
- The study will clarify the role of SCS in improving quality of life and reducing healthcare costs for FBSS patients.
- Findings will inform clinical practice guidelines regarding SCS for FBSS.
