Chronic, intractable predominant low back pain Signs and Symptoms Low back pain
Conditions
Interventions
Following enrollment eligible subjects will be entering a SCS trial phase. SCS involves the surgical placement of two leads (which look like very thin wires) into a small area near the spinal cord. El
Sponsors
Nevro Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with chronic, intractable predominant pain of the low back with or without leg pain 2. Considering daily activity and rest, report a recall average NRS score for low back pain of =5, and leg pain less than low back pain, during the previous 14 days prior to study enrollment 3. An appropriate candidate for HF10™ therapy and for the surgical procedures required in this study based on the clinical judgment of the implanting physician 4. Previously agreed to receive a Senza SCS system and participate in a trial phase 5. If taking them, be on stable chronic pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in the study and be willing to stay on those medications with no dose adjustments until study completion or study withdrawal, whichever comes first 6. 18 years of age or older at the time of enrollment 7. Willing and able to comply with study-related requirements, procedures, and visits 8. Capable of subjective evaluation, able to read and understand ethics committee (EC) approved written questionnaires, and are able to read, understand and sign the EC-approved written informed consent, all of which will be in Australian English 9. Capable of subjective evaluation, able to read and understand questionnaires, and are able to read, understand and sign the written inform consent, all of which will be in Australian English 10. Adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator
Exclusion criteria
Exclusion criteria: 1. Mmedical 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 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 and the subject’s medical history 3. 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, central deafferentation syndrome, Complex Regional Pain Syndrome, or acute herniating disc, as determined by the investigator 4. Any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention 5. Undergone an interventional procedure and/or surgery to treat low back or leg pain in the last 30 days 6. A condition currently requiring or likely to require diathermy 7. A condition currently requiring or likely to require surgery during the study period 8. Metastatic malignant disease or active local malignant disease 9. Life expectancy of less than 1 year 10. Active systemic or local infection 11. Pregnancy or plans to become pregnant during the course of the study (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) 12. A significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs) within 6 months of enrollment 13. Concomitant participation or plans to participate in another clinical study overlapping in time with the present clinical study. 14. An existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other non-Senza SCS devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief is assessed using a numerical rating scale (NRS) at 7 days +/- 5 days and 14 days +/- 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Low back pain intensity is measured using Numerical Rating Scale (NRS) values recorded in pain diaries at 7 days +/- 5 days and 14 days +/- 5 days 2. Leg pain intensity is measured using Numerical Rating Scale (NRS) values recorded in pain diaries at 7 days +/- 5 days and 14 days +/- 5 days 3. Clinician global impression of change (CGIC) is assessed by the Clinician Global Impression of Change scale at 7 days +/- 5 days and 14 days +/- 5 days 4. Subject global impression of change (PGIC) is assessed by the Patient Global Impression of Change scale at 7 days +/- 5 days and 14 days +/- 5 days 5. Subject preference for medial or lateral stimulation is assessed by the Subject Preference Questionnaire at 14 days +/- 5 days 6. Incidence of unanticipated adverse device effects (UADEs) is observed at 7 days +/- 5 days and 14 days +/- 5 days | — |
Countries
Australia
Contacts
Public ContactKerry Bradley
Outcome results
None listed