Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

NCT ID: NCT05497037

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-02-08

Brief Summary

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

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham Control Group

Subject receiving fake stimulation (no stimulation but same device procedure with PRF group)

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

Sham stimulation for 15 min

PRF Group

Subject receiving 500 KHz PRF stimulation for 15 min

Group Type: ACTIVE_COMPARATOR

PRF stimulation

Intervention Type: DEVICE

One time 500 kHZ stimulation for 15 min

Interventions

PRF stimulation

One time 500 kHZ stimulation for 15 min

Intervention Type: DEVICE

Sham stimulation

Sham stimulation for 15 min

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GiMer Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Veterans General Hospital-Taipei

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CTS001

Identifier Type: -

Identifier Source: org_study_id