Spinal Cord Stimulation Versus Instrumentation for FBSS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Spinal Cord Stimulation Device

The spinal cord stimulators WaveWriter AlphaTM (Boston Scientific) are designed to treat chronic back or leg pain by electrically stimulating the spinal cord. It is a well established worldwide licensed device. Percutaneous lead(-s) are implanted in the epidural space of the thoracic spine during the initial procedure. After discharge a trial phase is initiated and performed according to local preferences and standard of operations (SOPs). Patients are monitored for any complications and pain reduction. If a significant pain reduction (\>50 % on the NRS scale for back pain) is achieved, the permanent implantable pulse generator (IPG) is implanted. Otherwise if the therapy remains non-beneficial throughout the trial phase, the leads will be explanted. Patients are allowed to crossover in the fusion group at any point of time.

Group Type EXPERIMENTAL

Spinal Cord Stimulation

Intervention Type DEVICE

Epidural application of electrical current to the spinal cord

Control - Lumbar Fusion surgery

The control group needs to represent the standard of care of current practice. Gold standard is lumbar fusion surgery \[Resnik 2005\]. Surgical instrumentation will be performed according to local preferences and SOPs. Safety and efficacy of these fusion techniques have been repeatedly proven

Group Type ACTIVE_COMPARATOR

Spinal Fusion Surgery

Intervention Type PROCEDURE

screw-rod system based spinal instrumentation

Interventions

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Spinal Cord Stimulation

Epidural application of electrical current to the spinal cord

Intervention Type DEVICE

Spinal Fusion Surgery

screw-rod system based spinal instrumentation

Intervention Type PROCEDURE

Other Intervention Names

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SCS

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No