This study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the Gimer NeuroBlock SCS Trialing System for the treatment of chronic back pain and/or lower limb pain. The NeuroBlock SCS Trialing System is an ultra-high frequency SCS device for the treatment of patients with chronic back pain and/or lower limb pain who are refractory to conservative pain management. After screening procedures, eligible subjects will enter the study which is comprised of a 1-week randomized testing period, a 1-week follow-up period and 2-week observation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
22
NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse
China Medical University Hospital
Taichung, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Veterans General Hospital-Taipei
Taipei, Taiwan
Effectiveness: Responder Rate
The responder rate of the test group and control group at the 2-week visit
Time frame: 2 weeks
Safety: AEs and SAEs
Incidence of adverse events (AEs) and serious AEs (SAEs)
Time frame: 4 weeks
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