This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain.
This study is a prospective, single-arm, open label, single center to confirm the effectiveness and safety of an ultra-high frequency (500 KHz) spinal cord stimulation in patients with chronic back pain or lower limb pain. The trial length is 14 days. Patients will be given ultrahigh frequency pulse stimulation, up to 3 times in every 24 hours, and VAS will be obtained at least once a day. Compared to previous study conducted last year, patient can now have two lead implant sites for different pain locations. The electrode implantation site will be epidural space instead of Dorsal Root Ganglion (DRG).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (\>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.
China Medical University Hospital
Taichung, Taiwan
Change in Visual Analog Score From Baseline to Day 14
To assess the analgesic effectiveness of ultra-high frequency spinal cord stimulation, as measured by Visual Analogue Scale (VAS, score min 0 no pain to max 10 worst pain) compared to baseline.
Time frame: 14 days
Record Incidence of Adverse Events
To evaluate safety of ultra-high frequency spinal cord stimulation by identifying the incidence rate of adverse events (AEs) and serious adverse events (SAEs) during the trial
Time frame: 14 days
The Brief Pain Inventory (BPI)
The change from baseline in functionality using the BPI evaluations
Time frame: 14 days
Incidence of Stimulation-induced Paresthesia
To determine the presence or absence of stimulation-induced paresthesia.
Time frame: 14 days
Pain Relief Medication Consumption
Amount of pain medication consumption, including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and weak opioids, compared to baseline
Time frame: 14 days
Oswestry Low Back Pain Disability Questionnaire (ODI)
The change from baseline in functionality using the ODI evaluations
Time frame: 14 days
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