Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: Sham stimulation; Device: PRF stimulation

• Registration Number: NCT05497037
• Lead Sponsor: GiMer Medical

Brief Summary

The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Primary Completion: 2022-12-31
• Status Verified: 2023-02
• Study Completion: 2023-02-08
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Male or female subjects aged ≥ 20 years old during the recruitment phase

2. Clinical diagnosis of CTS：

   1. Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV
   2. Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase

3. Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications

4. The subject is willing and able to comply with the procedure and requirements of this trial

5. The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements

Exclusion Criteria

1. Wrist fractures or cysts at the CTS affected side
2. Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side
3. Receiving upper limb (including neck) surgery
4. Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months
5. With a past medical history of diabetic polyneuropathy
6. With a past medical history of rheumatoid arthritis
7. With a past medical history of epilepsy
8. Body Mass Index (BMI) > 40 kg/m2
9. Participation in any investigational study in the last 2 weeks or current enrollment in any trial.
10. Active infection at the stimulator contact site during the recruitment phase
11. Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion
12. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control Group	Sham stimulation	Subject receiving fake stimulation (no stimulation but same device procedure with PRF group)
PRF Group	PRF stimulation	Subject receiving 500 KHz PRF stimulation for 15 min

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)	Up to 14 days
Effectiveness: The responder rate of the PRF group and Sham-Control group	1 hour after end of stimulation
Safety: Change in Nerve Conduction Velocity 14th day compared to baseline	14 days	Median nerve sensory latency time change over 20%

Secondary Outcome Measures

Name	Time	Method
Change in PGIC scale in treatment and sham-controlled compared to baseline	1hr, 3, 7, 14 days after end of stimulation
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 BCTQ-FSS score in treatment and sham-controlled compared to baseline	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

Trial Locations

Locations (5)

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan

Hualien Tzu Chi Hospital; 🇨🇳 Hualien City, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Veterans General Hospital-Taipei; 🇨🇳 Taipei, Taiwan

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan