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Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
California - Northern
Nevro Corp
 
Acronym KP IRB No.
NSRBP 1425294
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Individuals with confirmed diagnosis of Back Pain
 
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.
 
Detailed Description
Difference between treatment groups in responder rates. Time Frame: 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).
 
Gender Age Limit
Male & Female
 
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
 
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

 
Keywords and/or Specific Medical Conditions
  • Back Pain
  • Signs and Symptoms
  • Neurologic Manifestations
  • Anesthesiology
  • Pain
 
KP Clinical Facility
  • Redwood City Medical Center
 
Clinical Area
  • Anesthesiology


Principal Investigator:
Taissa Cherry, MD
Contact Information:
- Comprehensive Clinical Reserach Unit KPNC
-650-299-4436
-Diana.M.Bruce@kp.org
-Redwood City Medical Center


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