Carpal Tunnel Syndrome
Conditions
Brief summary
The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.
Interventions
DEVICEPRF stimulation
One time 500 kHZ stimulation for 15 min
DEVICESham stimulation
Sham stimulation for 15 min
Sponsors
GiMer Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 14 days | Median nerve sensory latency time change over 20% |
Secondary
| Measure | Time frame |
|---|---|
| Change in GSS score 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 BCTQ-FSS score in treatment and sham-controlled compared to baseline | 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 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 |
Countries
Taiwan
Outcome results
None listed