Chronic, intractable, back and/or leg pain of neuropathic origin Signs and Symptoms Chronic intractable pain
Conditions
Sponsors
Nevro Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have chronic intractable back pain and/or leg pain of neuropathic origin, as determined by the physician 2. An appropriate candidate for spinal cord stimulation and/or surgical lead placement as determined by the physician 3. Already scheduled for either a commercial trial with Nevro or a permanent implant of the Senza system (with surgical lead only) 4. Be 18 years of age or older at the time of enrollment 5. Be able to read and understand the Patient Informed Consent Form 6. Be willing and capable of giving informed consent
Exclusion criteria
Exclusion criteria: 1. Contraindicated for surgical lead placement and/or spinal cord stimulation; physician should reference labeling for precautions, warnings and indications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rate at 3 months (a responder is defined as a subject who experiences =30% pain reduction compared to baseline as assessed by NRS & improvement in health status per the patient global impression of change questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain is measured using the numerical rating scale (NRS) at baseline, end of trial, 3, 6 and 12 months 2. Disability is measured using the Oswestry Disability Index (ODI) at baseline, 3, 6 and 12 months 3. Quality of life is measured using the EQ-5D-5L at baseline, 3, 6 and 12 months 4. Opioid intake is measured using a medication log at baseline, end of trial, 3, 6, 12 months 5. Health status is measured using the patient/physician global impression of change questionnaire at end of trial, 3, 6, 12 months 6. Participant satisfaction with the therapy is measured using the subject satisfaction questionnaire at 3,6 and 12 months | — |
Countries
Belgium, United States of America
Contacts
Public ContactBrad Gliner
Outcome results
None listed