MedTrace Logo

Spinal Cord Stimulation Versus Instrumentation for FBSS

NCT05466110 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-04-14

No results posted yet for this study

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

DEVICE

Spinal Cord Stimulation

Epidural application of electrical current to the spinal cord

PROCEDURE

Spinal Fusion Surgery

screw-rod system based spinal instrumentation

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University Hospital Augsburg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2024-11-30
Completion
2025-05-31
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05466110 on ClinicalTrials.gov