The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
58
One time 500 kHZ stimulation for 15 min
Sham stimulation for 15 min
Hualien Tzu Chi Hospital
Hualien City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Veterans General Hospital-Taipei
Taipei, Taiwan
Effectiveness: The responder rate of the PRF group and Sham-Control group
Time frame: 1 hour after end of stimulation
Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to 14 days
Safety: Change in Nerve Conduction Velocity 14th day compared to baseline
Median nerve sensory latency time change over 20%
Time frame: 14 days
Proportion in responder in treatment and sham-controlled groups
Time frame: 3, 7, 14 days after end of stimulation
Change in NRS score in treatment and sham-controlled groups compared to baseline
Time frame: 1hr, 3, 7, 14 days after end of stimulation
Change in PGIC scale in treatment and sham-controlled compared to baseline
Time frame: 1hr, 3, 7, 14 days after end of stimulation
Change in GSS score in treatment and sham-controlled compared to baseline
Time frame: 1hr, 3, 7, 14 days after end of stimulation
Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline
Time frame: 14 days after end of stimulation
Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline
Time frame: 14 days after end of stimulation
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Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan