Chronic, intractable predominant leg pain Signs and Symptoms
Conditions
Sponsors
Nevro Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Predominant leg pain either idiopathic in origin or from failed back surgery syndrome which has been refractory to conservative therapy for a minimum of 3 months 2. Average leg pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment 3. Average leg pain intensity > average back pain intensity on the Visual Analog Scale (VAS) by 2 cm at enrollment 4. Neuropathic pain as clinically determined by the investigator 5. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the Baseline Visit 6. Be an appropriate candidate for HF10 therapy 7. At least 18 years of age at time of enrollment 8. Willing and capable of giving written informed consent prior to any study -related assessment 9. Was evaluated at the investigational site at least once prior to screen for the pain condition related to the study 10. Willing and able to comply with study-related requirements, assessments and visits 11. Capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written inform consent in English
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 assessments, 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 the investigator in consultation with a clinical psychologist if applicable 3. 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 spinal stenosis 4. A visceral pain in the area being treated 5. A current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus 6. A diagnosis of scoliosis that precludes lead placement 7. Leg pain that occurs only with weight bearing 8. Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain 9. Existing drug pump and/or SCS system or another active implantable device such as a pacemaker (switched On or Off) 10. Have a condition currently requiring or likely to require diathermy 11. Metastatic malignant disease or active local malignant disease 12. A life expectancy of less than 1 year 13. An active systemic or local infection 14. 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) 15. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) 16. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study 17. Involved in an injury claim under current litigation 18. A pending or approved work cover claim
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate at 3 months (a responder is defined as a subject who experiences =50% leg pain reduction compared to baseline as assessed by VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects with a successful trial phase, defined as at least 50% leg pain reduction as assessed by VAS at the End of Trial phase 2. Change from baseline in mean leg pain, assessed by VAS at End of Trial, 1, 3, 6, 9 and 12 months 3. Change from baseline in mean back pain, assessed by VAS at baseline, End of Trial, 1, 3, 6, 9 and 12 months 3. Percentage change from baseline in mean leg pain, assessed by VAS at End of the Trial, 1, 3, 6, 9 and 12 months 4. Percentage change from baseline in mean back pain, assessed by VAS at End of the Trial, 1, 3, 6, 9 and 12 months* 5. Percentage of subjects who experience at least 50% reduction in leg pain assessed by VAS compared to baseline at End of Trial, 1, 3, 6, 9 and 12 months 6. Percentage of subjects who experience at least 50% reduction in back pain assessed by VAS compared to baseline at End of Trial, 1, 3, 6, 9 and 12 months* 7. Change from baseline in quality of life, assessed by Short-Form Health Survey (SF-12) at 3, 6 and 12 months 8. Change from baseline in disability, assessed by Oswestry Disability Index (ODI) at 3, 6 and 12 months 9. Opioid usage, measured using standard clinical question to the subject and collection via a CRF, at baseline, end of SCS trial period, 1, 3, 6, 9 and 12 months 10. Subject's impression of change in general health status, assessed by the Patient Global Impression of Change instrument (PGIC) at End of Trial, 1, 3, 6, 9 and 12 months 11. Investigator’s impression of change in the subject’s general health status, assessed by the Clinician Global Impression of Change instrument (CGIC) at End of Trial, 1, 3, 6, 9 and 12 months 12. Incidence of unanticipated adverse device effects (UADEs), measured using standard clinical question to the subject and collection via a CRF, at baseline, en | — |
Countries
Australia
Contacts
Public ContactAdele Barnard
Outcome results
None listed