ClinicalTrials.gg
CompletedNCT05497037Updated Feb 27, 2023

Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome

An interventional study of PRF stimulation and Sham stimulation in Carpal Tunnel Syndrome, sponsored by GiMer Medical. Completed at 5 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by GiMer Medical · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2022, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 39 studies in Carpal Tunnel Syndrome with a site in Taiwan — 5 open to participants now, 5 under way, none of them phase 3. Carpal Tunnel Syndrome · Taiwan.

Enrollment
17th of 38
58 · median 54
Started
2022
the only one that year
No phase
38 of 39
5 open now
Registered
34th of 39
by date
Lead sponsor
1 of 39
GiMer Medical

Among the 39 studies in Carpal Tunnel Syndrome with a site in Taiwan, this one is the 17th largest by enrollment of the 38 interventional ones that give a count, is the only one that started in 2022, is one of 38 with no phase, and was the 34th registered.

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

Browse Carpal Tunnel Syndrome studies →

Open to participants now

5 of the 39 studies in Carpal Tunnel Syndrome with a site in Taiwan are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 73 Carpal Tunnel Syndrome studies recruiting now, 27 (37%) set no upper age limit and 37 (51%) stop at 75 or younger; 1 takes children under 18; 10 take healthy volunteers.

This study: 20 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 39 studies in Carpal Tunnel Syndrome with a site in Taiwan, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Carpal Tunnel Syndrome
04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , and has signed their written informed consent in accordance with IRB requirements

Exclusion criteria

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 /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. (BMI) > 40 kg/m2
  9. Participation in any 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
58 participants (actual)

Study arms

  • Sham comparator
    Sham Control Group

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

    Device: Sham stimulation

  • Active comparator
    PRF Group

    Subject receiving 500 KHz PRF stimulation for 15 min

    Device: PRF stimulation

Interventions

  • DevicePRF stimulation

    One time 500 kHZ stimulation for 15 min

  • DeviceSham stimulation

    Sham stimulation for 15 min

06

What researchers measure

Primary outcomes

  1. Effectiveness: The responder rate of the PRF group and Sham-Control group

    Time frame: 1 hour after end of stimulation

  2. Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)

    Time frame: Up to 14 days

  3. Safety: Change in Nerve Conduction Velocity 14th day compared to baseline

    Median nerve sensory latency time change over 20%

    Time frame: 14 days

Secondary outcomes

  1. Proportion in responder in treatment and sham-controlled groups

    Time frame: 3, 7, 14 days after end of stimulation

  2. Change in NRS score in treatment and sham-controlled groups compared to baseline

    Time frame: 1hr, 3, 7, 14 days after end of stimulation

  3. Change in PGIC scale in treatment and sham-controlled compared to baseline

    Time frame: 1hr, 3, 7, 14 days after end of stimulation

  4. Change in GSS score in treatment and sham-controlled compared to baseline

    Time frame: 1hr, 3, 7, 14 days after end of stimulation

  5. Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline

    Time frame: 14 days after end of stimulation

  6. Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline

    Time frame: 14 days after end of stimulation

07

Study locations

5 sites
  • 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, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2022 to primary completion in Dec 2022, 9 months.

Of 261 interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2022
First posted
Aug 11, 2022
StartActual
Mar 9, 2022
Primary completionActual
Dec 31, 2022
CompletionActual
Feb 8, 2023
Last update
Feb 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05497037
Lead sponsor
GiMer Medical
Responsible party
Sponsor
First posted
Aug 11, 2022
Start date
Mar 9, 2022
Primary completion
Dec 31, 2022
Completion
Feb 8, 2023
Last update
Feb 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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