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The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Control Group | Sham Comparator | Subject receiving fake stimulation (no stimulation but same device procedure with PRF group) |
|
| PRF Group | Active Comparator | Subject receiving 500 KHz PRF stimulation for 15 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRF stimulation | Device | One time 500 kHZ stimulation for 15 min |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: The responder rate of the PRF group and Sham-Control group | 1 hour after end of stimulation | |
| Safety: Incidence of adverse events (AEs) and serious AEs (SAEs) | Up to 14 days | |
| Safety: Change in Nerve Conduction Velocity 14th day compared to baseline | Median nerve sensory latency time change over 20% | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion in responder in treatment and sham-controlled groups | 3, 7, 14 days after end of stimulation | |
| Change in NRS score in treatment and sham-controlled groups compared to baseline | 1hr, 3, 7, 14 days after end of stimulation |
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Inclusion Criteria:
Male or female subjects aged ≥ 20 years old during the recruitment phase
Clinical diagnosis of CTS:
Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications
The subject is willing and able to comply with the procedure and requirements of this trial
The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hualien Tzu Chi Hospital | Hualien City | Taiwan | ||||
| Chung Shan Medical University Hospital |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Sham stimulation |
| Device |
Sham stimulation for 15 min |
|
| Change in PGIC scale in treatment and sham-controlled compared to baseline | 1hr, 3, 7, 14 days after end of stimulation |
| Change in GSS score in treatment and sham-controlled compared to baseline | 1hr, 3, 7, 14 days after end of stimulation |
| Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline | 14 days after end of stimulation |
| Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline | 14 days after end of stimulation |
| Taichung |
| Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Veterans General Hospital-Taipei | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |