FBSS patients with predominant leg pain Patië
Conditions
Interventions
All subjects will have a Trial Phase with a Senza®
external trial stimulator of min 7 days and max 21 days to determine if they respond to HF10™
SCS therapy.
Following the Trial Phase, subjects will be assessed for their pain, and those who have a successful trial (defined as a 50% or greater leg pain reduction from Baseline) will proceed to
Sponsors
Nevro Corp.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with Failed Back Surgery Syndrome which has been refractory to conservative therapy for a minimum of 3 months and indicated for SCS as per Dutch SCS guidelines and as approved by the Dutch insurance companies 2. Average leg pain intensity of ¡Ý 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment 3. Average back pain intensity ¡Ü average leg pain intensity on the Visual Analog Scale (VAS) at enrollment 4. An adult (¡Ý 18 years of age) at time of enrollment
Exclusion criteria
Exclusion criteria: 1. 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, 2. 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 a psychologist 3. A diagnosis of scoliosis that precludes lead placement 4. Radiographic evidence of mechanical spinal instability requiring fusion. 5. Pain that is significantly exacerbated by activity or significantly alleviated by rest 6. Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain 7. Existing drug pump and/or SCS system or another active implantable device such as a pacemaker (switched On or Off) 8. Prior experience with SCS 9. Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| • Percentage of subjects with a successful trial • Average reduction in leg and back pain, as assessed by VAS, at the different intervals • Percentage change in mean leg and back pain, as assessed by VAS, at the different intervals • Responder rate for leg and back pain, as assessed by VAS, at the different intervals • Change in health status (assessed by SF-36) • Change in disability (assessed by ODI) • Change in emotional mood (assessed by HADS) • Subject's impression of change (assessed by the Patient Global Impression of Change instrument - PGIC) • Investigator¡¯s impression of change (assessed by the Clinician Global Impression of Change instrument - CGIC) • Change in pain experience (MPQ-DLV) • Change in Pain Catastrophizing (PCS) • subject¡¯s satisfaction • Assessment of indirect costs (iPCQ) • Change in pain medication | — |
Contacts
Public ContactAnja Schaeken
Outcome results
None listed