Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Randomized, Double-Blind, Two-Arm, Sham-Controlled, Parallel-Design Trial to Assess the Efficacy and Safety of Carpal Stim for Treating Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: PRF stimulation
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged ≥ 20 years old during the recruitment phase Clinical diagnosis of CTS： Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase 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: Wrist fractures or cysts at the CTS affected side Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side Receiving upper limb (including neck) surgery Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months With a past medical history of diabetic polyneuropathy With a past medical history of rheumatoid arthritis With a past medical history of epilepsy Body Mass Index (BMI) > 40 kg/m2 Participation in any investigational study in the last 2 weeks or current enrollment in any trial. Active infection at the stimulator contact site during the recruitment phase Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion Patients with implanted medical devices that are electronic products, such as implantable cardioverter defibrillators, pacemakers, spinal cord stimulation systems, or spinal cord drug infusion pumps

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Control Group<br>Subject receiving fake stimulation (no stimulation but same device procedure with PRF group) | Device: Sham stimulation<br>* Sham stimulation for 15 min<br>|
| Active Comparator: PRF Group<br>Subject receiving 500 KHz PRF stimulation for 15 min | Device: PRF stimulation<br>* One time 500 kHZ stimulation for 15 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |