Chronic back and leg pain in failed back surgery syndrome (FBSS) patients Surgery
Conditions
Interventions
Subjects who meet screening criteria will receive a permanent SCS implant and randomised to:
1. ON arm for first period/OFF arm for second period or
2. OFF arm for first period/ON arm for second per
Sponsors
Nevro Corporation (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An adult (at least 18 years of age) 2. Capable of giving informed consent 3. An appropriate candidate for implantation of a spinal cord stimulator 4. Able to comply with the requirements of the study visits and self-assessment questionnaires 5. On stable pain medications for at least 4 weeks prior to the baseline visit 6. A failed back surgery syndrome (FBSS) patient with back pain intensity of at least 5 cm out of 10 cm, with radiating pain that originates from lumbar, L3, L4, L5, and/or S1
Exclusion criteria
Exclusion criteria: 1. Progressive neurological disease (multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, cauda equina syndrome, and herniated nucleus pulposis causing progressive motor deficit etc.) as manifested by an unstable neurologic condition 2. Has significant pain in other areas that is not intended to be treated with SCS and that could interfere with accurate pain reporting, as determined by the Investigator 3. Significant mechanical instability as determined by the Investigator 4. Pain intensity of always 10 on a 0-10 scale over the past 6 months based on subject recall 5. Metastatic malignant disease or active local malignant disease 6. A life expectancy of less than 1 year 7. A systemic infection or local infection that would contraindicate SCS placement 8. A female of child bearing potential who is pregnant/lactating or not using adequate birth control 9. Evidence of an active disruptive psychological/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 10. Addiction to any of the following: illicit drugs, alcohol (5 or more drinks/day) and/or medication 11. Bleeding diathesis such as coagulopathy or thrombocytopenia 12. Immunocompromised and at risk for infection 13. Diabetic 14. Unresolved issue of secondary gain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Visual Analogue Scale (VAS) score for back pain: measured at baseline, the mid-point and end of each period 2. Emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. VAS score for leg pain: measured at baseline, the mid-point and end of each period 2. Sleep disturbance: measured at baseline, the mid-point and end of each period 3. Oswestry Disability Index: measured at baseline and the end of each period 4. Subject diary: measured at baseline, prior to mid-point and end of each period, following wash-out 5. Subject's assessment of group assignment: measured at the end of each period 6. Changes in medication usage: measured at baseline, the mid-point and end of each period | — |
Countries
Belgium
Outcome results
None listed