Spinal Cord Stimulation Versus Instrumentation for FBSS (PROMISE)
Failed Back Surgery Syndrome, SCS, Neuromodulation
About this trial
This is an interventional treatment trial for Failed Back Surgery Syndrome
Eligibility Criteria
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
Sites / Locations
- University Hospital Augsburg Department of NeurosurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Spinal Cord Stimulation Device
Control - Lumbar Fusion surgery
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.
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