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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Epidural application of electrical current to the spinal cord
screw-rod system based spinal instrumentation
University Hospital Augsburg Department of Neurosurgery
Augsburg, Bavaria, Germany
RECRUITINGOswestry disability index / ODI
A patient reported outcome measure to rate pain and disability
Time frame: 12 months after intervention
Adverse events
Comparison of complication rates
Time frame: 12 months after intervention
SF36
Score to assess quality of life
Time frame: 12 months after intervention
EuroQOL 5D
Score to assess quality of life
Time frame: 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.
Time frame: through study completion, an average of 2 years
Crossover rates
Rates of crossover to another therapy arm
Time frame: 12 months after intervention
Pain medication
Amount of analgesics taken (drug, dose, mode of application)
Time frame: 12 months after intervention
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