Carpal Tunnel SyndromeNCT05497037
Safety and Efficacy of Carpal Stim in Treating Carpal Tunnel Syndrome
A study testing PRF stimulation in people with Carpal Tunnel Syndrome, run by GiMer Medical at 5 sites in Taiwan.
Trial summary
The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- PRF stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 5 sitesTaiwan
- Study dates
- 9 Mar 2022to 8 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 20 years old during the recruitment phase
- Clinical diagnosis of CTS：
- Diagnosis of CTS was confirmed by Nerve Conduction Velocity (NCV) but not limited to NCV
- Symptoms consistent with CTS for at least 3 months and the numerical rating scale (NRS) score ≥ 5 during the recruitment phase
- Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications
- The subject is willing and able to comply with the procedure and requirements of this trial
- The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements
Who cannot join
- Wrist fractures or cysts at the CTS affected side
- Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side
- Receiving upper limb (including neck) surgery
- Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months
- With a past medical history of diabetic polyneuropathy
- With a past medical history of rheumatoid arthritis
Show all 12Show fewer
- With a past medical history of epilepsy
- Body Mass Index (BMI) > 40 kg/m2
- Participation in any investigational study in the last 2 weeks or current enrollment in any trial.
- Active infection at the stimulator contact site during the recruitment phase
- Pregnant women or diagnosed with postpartum edema in the wrist per investigator's discretion
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Hualien Tzu Chi Hospital
Hualien City
Chung Shan Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Veterans General Hospital-Taipei
Taipei
Linkou Chang Gung Memorial Hospital
Taoyuan
About this study
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
The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- PRF stimulation, Sham stimulation
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF stimulationDevice
One time 500 kHZ stimulation for 15 min
Sham stimulationDevice
Sham stimulation for 15 min
| Study group | Role | What they receive |
|---|---|---|
| Sham Control Group | Sham comparator | Subject receiving fake stimulation (no stimulation but same device procedure with PRF group) Receives: Device: Sham stimulation |
| PRF Group | Active comparator | Subject receiving 500 KHz PRF stimulation for 15 min Receives: Device: PRF stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: The responder rate of the PRF group and Sham-Control group
Measured: 1 hour after end of stimulation
Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)
Measured: Up to 14 days
Safety: Change in Nerve Conduction Velocity 14th day compared to baseline
Median nerve sensory latency time change over 20%
Measured: 14 days
Secondary outcomes (6)
Proportion in responder in treatment and sham-controlled groups
Measured: 3, 7, 14 days after end of stimulation
Change in NRS score in treatment and sham-controlled groups compared to baseline
Measured: 1hr, 3, 7, 14 days after end of stimulation
Change in PGIC scale in treatment and sham-controlled compared to baseline
Measured: 1hr, 3, 7, 14 days after end of stimulation
Change in GSS score in treatment and sham-controlled compared to baseline
Measured: 1hr, 3, 7, 14 days after end of stimulation
Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline
Measured: 14 days after end of stimulation
Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline
Measured: 14 days after end of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start9 Mar 2022
- Primary completion31 Dec 2022
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- GiMer Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497037
- Sponsor's protocol ID
- CTS001
- Status last verified
- Feb 2023
- First submitted
- 9 Aug 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05497037
- Acronym / sponsor ID
- CTS001
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- GiMer MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy and safety of Carpal Stim for pain relief in CTS subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Control Group | Sham comparator | Device: Sham stimulationSubject receiving fake stimulation (no stimulation but same device procedure with PRF group) |
| PRF Group | Active comparator | Device: PRF stimulationSubject receiving 500 KHz PRF stimulation for 15 min |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged ≥ 20 years old during the recruitment phase
- Clinical diagnosis of CTS：
- Willing to abstain from any other treatment or therapy for CTS throughout the trial except protocol-described medications
- The subject is willing and able to comply with the procedure and requirements of this trial
- The participant is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements
Key exclusion criteria (12 listed)
- Wrist fractures or cysts at the CTS affected side
- Wrist surgery within the past 3 months, especially carpal tunnel release surgery at the CTS affected side
- Receiving upper limb (including neck) surgery
- Injections of corticosteroids/cortisone into the wrist or hand within the past 3 months
- With a past medical history of diabetic polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRF stimulationOne time 500 kHZ stimulation for 15 min | Device | PRF Group |
| Sham stimulationSham stimulation for 15 min | Device | Sham Control Group |
Primary outcome
Effectiveness: The responder rate of the PRF group and Sham-Control group
Time frame: 1 hour after end of stimulation
Safety: Incidence of adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to 14 days
Safety: Change in Nerve Conduction Velocity 14th day compared to baseline
Time frame: 14 days
Median nerve sensory latency time change over 20%
6 secondary outcomes
Proportion in responder in treatment and sham-controlled groups
Time frame: 3, 7, 14 days after end of stimulation
Change in NRS score in treatment and sham-controlled groups compared to baseline
Time frame: 1hr, 3, 7, 14 days after end of stimulation
Change in PGIC scale in treatment and sham-controlled compared to baseline
Time frame: 1hr, 3, 7, 14 days after end of stimulation
Change in GSS score in treatment and sham-controlled compared to baseline
Time frame: 1hr, 3, 7, 14 days after end of stimulation
Change in BCTQ-SSS score in treatment and sham-controlled compared to baseline
Time frame: 14 days after end of stimulation
Change in BCTQ-FSS score in treatment and sham-controlled compared to baseline
Time frame: 14 days after end of stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF stimulation in people with Carpal Tunnel Syndrome, run by GiMer Medical at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: The responder rate of the PRF group and Sham-Control group (time frame: 1 hour after end of stimulation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.