Spinal Cord Stimulation Versus Instrumentation for FBSS

Last updated: April 13, 2023
Sponsor: University Hospital Augsburg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Spinal Surgery

Spine Athroplasty

Treatment

N/A

Clinical Study ID

NCT05466110
22-0221
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years
  • Symptomatic degenerative disc disease with LBP as a predominant symptom for at least 6months following pervious surgery for disc herniation
  • ODI score at least 21
  • Correctly signed informed consent form

Exclusion

Exclusion Criteria:

  • Spinal stenosis resulting in spinal claudication or neurological deficits
  • Spinal Instability (> 3 mm Motion on dynamic Lumbar X-rays)
  • Major psychiatric disorder

Study Design

Total Participants: 84
Study Start date:
March 20, 2023
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • University Hospital Augsburg Department of Neurosurgery

    Augsburg, Bavaria 86156
    Germany

    Active - Recruiting

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