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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
CMM 		Conventional Medical Management
  • Device: HF10 Therapy
    Senza 10 kHz Spinal Cord Stimulation
  • Other: CMM
    Conventional Medical Management
Active Comparator
HF10 + CMM 		Addition of HF10 therapy to CMM
  • Device: HF10 Therapy
    Senza 10 kHz Spinal Cord Stimulation
  • Other: CMM
    Conventional Medical Management

Recruiting Locations

More Details

NCT ID
NCT03680846
Status
Unknown status
Sponsor
Nevro Corp

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.