Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-Surgical Refractory Back Pain

Conditions
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Back Pain

Intervention / Treatment
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* Device: HF10 Therapy
* Other: CMM


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component and are not eligible for spine surgery Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain Qualifying pain score Be on stable pain medications, as determined by the Investigator Be willing and capable of giving informed consent Be willing and able to comply with study-related requirements, procedures, and visits 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: Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders Have a medical condition or pain in other area(s), not intended to be treated in this study Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain Have any addictions as determined by the Investigator Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker Have prior experience with neuromodulation devices Other general exclusions applicable for SCS devices Be involved in an injury claim under current litigation Have a pending or approved worker's compensation claim

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CMM<br>Conventional Medical Management | Other: CMM<br>* Conventional Medical Management<br>|
| Active Comparator: HF10 + CMM<br>Addition of HF10 therapy to CMM | Device: HF10 Therapy<br>* Senza 10 kHz Spinal Cord Stimulation<br>Other: CMM<br>* Conventional Medical Management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |