Back Pain
Conditions
Brief summary
This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10™ Therapy) delivered through the Senza system in subjects with chronic refractory back pain (with or without leg pain) who are not considered candidates for spine surgery. This study is a multi-center, prospective, randomized study to compare the two treatment groups.
Interventions
DEVICEHF10 Therapy
Senza 10 kHz Spinal Cord Stimulation
OTHERCMM
Conventional Medical Management
Sponsors
Nevro Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery 2. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain 3. Qualifying pain score 4. Be on stable pain medications, as determined by the Investigator 5. Be willing and capable of giving informed consent 6. Be willing and able to comply with study-related requirements, procedures, and visits 7. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent Key
Exclusion criteria
1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders 2. Have a medical condition or pain in other area(s), not intended to be treated in this study 3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator 4. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain 5. Have any addictions as determined by the Investigator 6. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker 7. Have prior experience with neuromodulation devices 8. Other general exclusions applicable for SCS devices 9. Be involved in an injury claim under current litigation 10. Have a pending or approved worker's compensation claim
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between treatment groups in responder rates. | 3 Months | Responder is defined as a subject who has at least 50% reduction in pain from Baseline as assessed by a 10 cm Visual Analog Scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability as Measured by Oswestry Disability Index | 6 months | Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score |
| Percentage change from baseline in back pain intensity (as assessed by VAS) | 6 months | — |
| Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire | 6 months | It measures the subject's health state as assessed in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with 5 levels. In addition there is an EQ VAS which records the patient's self-rated health on a vertical visual analogue scale. The scores on these five dimensions can be presented as a health profile or can be converted to a single number summary called the "index value". |
| Global impression of change | 6 months | Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire |
| Change from baseline in opioid equivalent medication usage in each group | 6 months | — |
| Neurological assessment | 3, 6 and 12 months | Assessment of motor, sensory and reflex functions. Clinicians shall characterize the findings as improved, maintained, or a deficit as compared with baseline status. |
| Incidences of adverse events | 3, 6 and 12 months | — |
Countries
United States
Contacts
STUDY_DIRECTORDavid Caraway, MD
Nevro Corp
Outcome results
None listed