Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

GiMer Medical

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Device: Sham stimulation; Device: PRF stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05497037

CTS001

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Sham Control Group

Sham Comparator group

Description:

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

Treatment:

Device: Sham stimulation

PRF Group

Active Comparator group

Description:

Subject receiving 500 KHz PRF stimulation for 15 min

Treatment:

Device: PRF stimulation