Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05497037
• Other study ID #: CTS001
• Status: Completed
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: February 8, 2023

Study information

• Verified date: February 2023
• Source: GiMer Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 8, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• PRF stimulation
One time 500 kHZ stimulation for 15 min
• Sham stimulation
Sham stimulation for 15 min

Locations

Country	Name	City	State
Taiwan	Hualien Tzu Chi Hospital	Hualien City
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Veterans General Hospital-Taipei	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
GiMer Medical

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness: The responder rate of the PRF group and Sham-Control group		1 hour after end of stimulation
Primary	Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)		Up to 14 days
Primary	Safety: Change in Nerve Conduction Velocity 14th day compared to baseline	Median nerve sensory latency time change over 20%	14 days
Secondary	Proportion in responder in treatment and sham-controlled groups		3, 7, 14 days after end of stimulation
Secondary	Change in NRS score in treatment and sham-controlled groups compared to baseline		1hr, 3, 7, 14 days after end of stimulation
Secondary	Change in PGIC scale in treatment and sham-controlled compared to baseline		1hr, 3, 7, 14 days after end of stimulation
Secondary	Change in GSS score in treatment and sham-controlled compared to baseline		1hr, 3, 7, 14 days after end of stimulation
Secondary	Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline		14 days after end of stimulation
Secondary	Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline		14 days after end of stimulation