NCT04693650

A Prospective, Multi-site, Randomized, Sham-Controlled, 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: GiMer Medical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Pain
• Low Back Pain
• Lower Limb Pain

Interventions

Type	Name	Description
DEVICE	NeuroBlock UHF stimulation	NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-02-01
• Completion: 2022-04-01
• First posted: 2021-01-05
• Last updated: 2023-02-27

Locations

4 sites across 1 country: Taiwan