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Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
Sponsor: Nevro Corp
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
211
Start Date
2018-09-05
Completion Date
2022-05-09
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
HF10 Therapy
Senza 10 kHz Spinal Cord Stimulation
CMM
Conventional Medical Management
Locations (1)
Nevro Corp
Redwood City, California, United States