Failed Back Surgery Syndrome, SCS, Neuromodulation, Spinal Cord Stimulation, Spinal Fusion, Low Back Pain
Conditions
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.
Interventions
DEVICESpinal Cord Stimulation
Epidural application of electrical current to the spinal cord
PROCEDURESpinal Fusion Surgery
screw-rod system based spinal instrumentation
Sponsors
Boston Scientific Corporation
University Hospital Augsburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry disability index / ODI | 12 months after intervention | A patient reported outcome measure to rate pain and disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 12 months after intervention | Comparison of complication rates |
| SF36 | 12 months after intervention | Score to assess quality of life |
| EuroQOL 5D | 12 months after intervention | Score to assess quality of life |
| Crossover rates | 12 months after intervention | Rates of crossover to another therapy arm |
| Pain medication | 12 months after intervention | Amount of analgesics taken (drug, dose, mode of application) |
| hospital length of stay | through study completion, an average of 2 years | 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. |
Countries
Germany
Contacts
Primary ContactEhab Shiban, MD
Backup ContactPhilipp Krauss, MD
Outcome results
None listed