Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being conducted to document the safety, clinical effectiveness and cost-effectiveness of high-frequency SCS at 10 kHz (HF10â„¢ 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMM | Other | Conventional Medical Management |
|
| HF10 + CMM | Active Comparator | Addition of HF10 therapy to CMM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HF10 Therapy | Device | Senza 10 kHz Spinal Cord Stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between treatment groups in responder rates. | 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) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disability as Measured by Oswestry Disability Index | Percentage of subjects with at least 10 point decrease from Baseline in Oswestry Disability Index (ODI) score | 6 months |
| Percentage change from baseline in back pain intensity (as assessed by VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| Observational Outcomes on reduction in pain using a 10 cm Visual Analog Scale (VAS) | Percentage change in back pain | 24 months |
| Observational Outcomes on disability using Oswestry Disability Index scores |
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Caraway, MD | Nevro Corp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nevro Corp | Redwood City | California | 94065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34854473 | Derived | O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2. | |
| 33463027 | Derived | Patel N, Calodney A, Kapural L, Province-Azalde R, Lad SP, Pilitsis J, Wu C, Cherry T, Subbaroyan J, Gliner B, Caraway D. High-Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Nonsurgical Refractory Back Pain: Design of a Pragmatic, Multicenter, Randomized Controlled Trial. Pain Pract. 2021 Feb;21(2):171-183. doi: 10.1111/papr.12945. Epub 2020 Sep 26. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CMM |
| Other |
Conventional Medical Management |
|
| 6 months |
| Changes in Quality of Life (QOL) as measured by EuroQol EQ-5D-5L questionnaire | 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". | 6 months |
| Global impression of change | Proportion of subjects reporting "better" or "great deal better" on the Patient Global Impression of Change (PGIC) questionnaire | 6 months |
| Change from baseline in opioid equivalent medication usage in each group | 6 months |
| Neurological assessment | Assessment of motor, sensory and reflex functions. Clinicians shall characterize the findings as improved, maintained, or a deficit as compared with baseline status. | 3, 6 and 12 months |
| Incidences of adverse events | 3, 6 and 12 months |
Percentage change from Baseline in ODI score
| 24 months |
| Observational Outcomes on Health related quality of life evaluation as measured by the 5 dimension EuroQol EQ-5D-5L questionnaire | Change in quality of life index compared to baseline | 24 months |