Clinical trial NCT05497037: Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: GiMer Medical
Sponsor class: INDUSTRY
First posted: 2022-08-11
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Effectiveness: The responder rate of the PRF group and Sham-Control group
timeFrame: 1 hour after end of stimulation
measure: Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)
timeFrame: Up to 14 days
measure: Safety: Change in Nerve Conduction Velocity 14th day compared to baseline
timeFrame: 14 days
Secondary outcomes:
measure: Proportion in responder in treatment and sham-controlled groups
timeFrame: 3, 7, 14 days after end of stimulation
measure: Change in NRS score in treatment and sham-controlled groups compared to baseline
timeFrame: 1hr, 3, 7, 14 days after end of stimulation
measure: Change in PGIC scale in treatment and sham-controlled compared to baseline
timeFrame: 1hr, 3, 7, 14 days after end of stimulation
measure: Change in GSS score in treatment and sham-controlled compared to baseline
timeFrame: 1hr, 3, 7, 14 days after end of stimulation
measure: Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline
timeFrame: 14 days after end of stimulation
measure: Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline
timeFrame: 14 days after end of stimulation
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital-Taipei
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References: