Spinal Cord Stimulation Versus Instrumentation for FBSS

Study Overview
=================
Brief 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.

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

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

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation
* Procedure: Spinal Fusion Surgery


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Stimulation Device<br>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. | Device: Spinal Cord Stimulation<br>* Epidural application of electrical current to the spinal cord<br>* Other names: SCS;|
| Active Comparator: Control - Lumbar Fusion surgery<br>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 | Procedure: Spinal Fusion Surgery<br>* screw-rod system based spinal instrumentation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry disability index / ODI | A patient reported outcome measure to rate pain and disability | 12 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Comparison of complication rates | 12 months after intervention | 
| SF36 | Score to assess quality of life | 12 months after intervention | 
| EuroQOL 5D | Score to assess quality of life | 12 months after intervention | 
| hospital length of stay | Time measured in days, counting from the first day of hospitalization until the day of discharge of the hospitalization the surgical intervention was performed. If surgery is performed as staged procedure in two separate hospitalizations (SCS) both hospitalizations are counted as described above and days are summed up. | through study completion, an average of 2 years | 
| Crossover rates | Rates of crossover to another therapy arm | 12 months after intervention | 
| Pain medication | Amount of analgesics taken (drug, dose, mode of application) | 12 months after intervention |