Chronic low back pain in subjects who have not had spinal surgery Signs and Symptoms Low back pain
Conditions
Interventions
Spinal Cord Stimulation with Nevro's Senza System
This is a single center, open label, prospective study to evaluate the effectiveness of the Senza System in subjects with chronic low
Sponsors
Nevro Corp (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than 18 years, less than 65 years old 2. Low back pain for more than 6 months having failed conservative treatment (e.g., physical therapy, multiple facet joint injections) 3. Low back pain intensity =5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment 4. Low back pain predominates over any radicular pain (VAS back pain 2 points or more greater than VAS leg pain) 5. Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography 6. On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator 7. Legally able to provide informed consent 8. Able to comply with study-related requirements, procedures and visits
Exclusion criteria
Exclusion criteria: 1. Had previous spinal fusion surgery 2. A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical central or foraminal spinal stenosis 3. Mechanical spine instability detected by a spinal surgeon (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by >5 degrees segmental angular movement) e.g. any forms of spondylolisthesis 4. A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator 5. Diabetic who is poorly controlled through diet and/or medication (determined by the Investigator) 6. Bleeding diathesis such as coagulopathy or thrombocytopenia 7. Immunocompromised and at an increased risk for infection 8. Systemic infection or local infection that would contraindicate SCS placement 9. Metastatic malignant disease or active local malignant disease 10. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) 11. Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication. 12. Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator 13. Life expectancy of less than 1 year 14. Concomitant participation in clinical trial (device or drug) 15. An existing drug pump, SCS system, and/or another active implantable device 16. An interventional procedure and/or surgery within the past 30 days for treatment of pain condition 17. Inability to manage the technical demands of the SCS equipment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of percentage change from Baseline in back pain (as measured by VAS) at 1, 3, 6, 9 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of percentage change from Baseline in leg pain (as measured by VAS) at 1, 3, 6, 9 and 12 months 2. Comparison of change from Baseline in functional changes as measured by the Oswestry Disability Index at 3, 6, 9, and 12 months 3. Comparison of change from Baseline in quality of life as measured by SF-36 at 3, 6, 9 and 12 months 4. Comparison of change from Baseline in quality of life as measured by EQ-5D at 3, 6, 9 and 12 months 5. The change in work status from Baseline to follow-ups at 3, 6, 9, and 12 months 6. Change from Baseline in sleep disturbance at 1, 3, 6, 9, and 12 months 7. Paresthesia generated by the stimulator at Post-Permanent Device Activation 8. Adverse events collected during the study at all visits 9. The percentage subjects who experience at least 50% reduction in pain due to SCS therapy (as assessed by VAS) for back pain at 3, 6 and 12 months 10. Percentage change from Baseline in back and leg pain (as assessed by Subject Diary VAS) at 1, 3, 6, 9 and 12 months 11. Change from Baseline in pain and opioid medication usage 12. To learn about the subject?s clinical trial experience through videotaping 13. To summarize the subject?s global impression of change 14. To summarize the subject?s satisfaction with the Senza System 15. To summarize subject?s willingness to recommend to another subject with same condition | — |
Countries
United Kingdom
Outcome results
None listed