HF10 Spinal Cord Stimulation for Chronic Back Pain

This study compares the safety, clinical effectiveness and cost-effectiveness of the HF10 therapy Senza spinal cord stimulator (SCS) with conventional medical management (CMM) or CMM alone for patients with non-surgical refractory back pain (NSRBP) who are not considered candidates for spine surgery.

Participation in this research study is expected to last approximately 14 months. Participating subjects will be randomly assigned to one of two treatment groups:

  1. Conventional medical treatments: under the direction of your study physician, you may receive a variety of treatments, such as medications and physical therapy.
  2. The study treatment HF10 therapy, delivered by Senza spinal cord stimulator [SCS]): your study physician will perform a trial procedure to see if the study procedure works for you and may implant a permanent device if it is successful. There is a temporary trial procedure, or a “test drive,” which usually lasts 5-7 days. If this successfully reduces your pain, you and your doctor will discuss a more permanent implant. You may also continue to receive medication or other medical treatments under the direction of your study physician.

If your pain relief is insufficient and you are unsatisfied with your treatment, you may qualify toswitch over to the other treatment group.

Clinicaltrials.gov NCT Number: NCT03680846

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