NCT05466110

Spinal Cord Stimulation Versus Instrumentation for FBSS

sPinal coRd stimulatiOn coMpared With Lumbar InStrumEntation for Low Back Pain After Previous Lumbar Decompression (PROMISE): a Prospective Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: University Hospital Augsburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.

Conditions

• Failed Back Surgery Syndrome
• SCS
• Neuromodulation
• Spinal Cord Stimulation
• Spinal Fusion
• Low Back Pain

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulation	Epidural application of electrical current to the spinal cord
PROCEDURE	Spinal Fusion Surgery	screw-rod system based spinal instrumentation

Timeline

• Start date: 2023-03-20
• Primary completion: 2024-11-01
• Completion: 2025-05-01
• First posted: 2022-07-20
• Last updated: 2023-04-14

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study