FBSS Clinical Trial
Official title:
Prospective, Clinical Pilot Study of High Frequency Wireless Spinal Cord Stimulation (SCS) in the Treatment of Chronic Pain With The Freedom Spinal Cord Stimulatory
The purpose of this study is to observe the efficacy of stimulation on over all pain relief as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal Cord Stimulator (SCS) System for low back and/or leg pain.
This is a non-blinded, short-term study for a maximum duration of 12 weeks in which 6
patients will receive a Freedom SCS System. Subjects will have chronic, intractable pain of
the trunk and/or lower limbs refractory to standard medical treatment; including unilateral
or bilateral pain. Stimulators will be placed in the epidural space and over exiting nerve
roots at vertebrae levels:
A. Bilateral T9-T10 epidural; B. Bilateral L1-L4 epidural. All Patients will be treated
below perception threshold with High Frequency settings (10.000 Hz, 30 μs).
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