Carpal Tunnel SyndromeNCT05067205
Minimal Invasive Carpal Tunnel Release With the Novel Device
A study testing Carpal tunnel release surgery in people with Carpal Tunnel Syndrome, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
This is a prospective, open-label, parallel-group, randomized controlled trial to evaluate the postoperative outcome after carpal tunnel release by using mini CTS releaser and open method with duration of 6 months estimated. 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?
- Carpal tunnel release surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Sep 2021to 31 Dec 2022
- 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
- 20 years of age and above.
- clinically symptomatic and electrophysiologically confirmed carpal tunnel syndrome.
- no response to conservative treatment.
- Signed Informed Consent and willing to comply with doctors and nurses' order.
Who cannot join
- Subjects with recurrent carpal tunnel syndrome
- Subjects with coexisting cervical radiculopathy
- Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolone per day or equivalent.
- Diabetic patients with pre-OP HbA1c >7%
- Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
- Known allergy/hypersensitivity to any of the components included into the investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Carpal Tunnel Decompression Using a Novel Ergonomic Releasing Instrument
This is a prospective, open-label, parallel-group, randomized controlled trial to evaluate the postoperative outcome after carpal tunnel release by using mini CTS releaser and open method with duration of 6 months estimated.
The study hypothesis is that mini CTS releaser can offer similar functional outcomes to the open approach and avoid the complications of the open surgery.
Read the detailed description
The current study is the first clinical trial of carpal tunnel syndrome treated by using a device - novel mini CTS releaser. The functional outcome and objective outcome will be recorded to prove the hypothesis that mini CTS releaser can offer similar functional outcomes to the open approach and decrease the complication rate in comparison of the open surgery.
When patients visit, the research physician confirms whether the eligibility criteria are met, and the physician verbally explains the research theme, purpose, and method of execution. After the patient's consent, he should sign the subject consent.
At baseline recruitment, a standardized in-person interview will be conducted by trained and certified study personnel according to structured questionnaires to obtain information on socio-demographic characteristics, habits of tobacco and alcohol use, peripheral blood sample will be also collected from each participant. All of the operated patients underwent a complete personal medical history review, detailed physical examination, as well as routine hematological tests.
Patients will be randomized 1:1 to mini CTS releaser group or to open release group. There will be 35 individuals in each treatment arm. The planned follow-up time will be scheduled.
Safety outcomes including adverse events and changes around surgical wound and neurologic sign will be recorded. Patients will be carefully observed and if any abnormality is noted, appropriate measures will be instituted. The surgical materials used are all certified by the Ministry of Health and Welfare in Taiwan. The possible side effects, such as infections or inflammatory reactions that may occur after surgery, will be given antibiotics or other appropriate treatments in accordance with standard medical procedures.
Data of baseline characteristics will be described using means with standard deviations (SDs) or medians and interquartile ranges (IQRs), or both for continuous variables and using frequencies (percentages) for categorical variables. Mean morphological measures (and changes) will be computed as averages across participants within each treatment group. Between-group baseline comparisons will be based on 2 independent two sample t test or Wilcoxon Mann-Whitney test for quantitative variables, and chi-square test or Fisher's exact test for categorical variables. P values less than 0.05 will be adjusted for multiple comparisons using Bonferroni correction. All statistical analyses will be performed using SAS software Version 9.4 (SAS Institute Inc., Cary, North Carolina).
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal tunnel release surgery
- Keywords
- Carpal Tunnel Syndrome
- 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.
Carpal tunnel release surgeryProcedure or surgery
Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks postoperatively
| Study group | Role | What they receive |
|---|---|---|
| open release | Sham comparator | A prospective, open-label, parallel-group to evaluate the postoperative outcome after carpal tunnel release by using open carpal tunnel release method with duration of 6 months estimated. Receives: Procedure: Carpal tunnel release surgery |
| mini CTS releaser | Experimental | A prospective, open-label, parallel-group to evaluate the postoperative outcome after carpal tunnel release by using mini CTS releaser method with duration of 6 months estimated. Receives: Procedure: Carpal tunnel release surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from preoperative BCTQ SSS at 4 Weeks
The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
Measured: preoperative and 4 weeks after surgery
Secondary outcomes (8)
Operation time
Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.
Measured: operation day
Wound size
Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.
Measured: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
Grip/pinch strength
Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.
Measured: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
Pain Scores on the Visual Analog Scale
Is a subjective assessment of pain. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. [0 (no pain), 10 (worst pain)]
Measured: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
Time off work
Differences in time off work between both procedures measured in days.
Measured: 24 weeks after surgery
Number of Participants with Adverse Events
Infection, secondary operation, scar hypertrophy, scar hyper-sensitivity, tenderness, and pillar pain
Measured: 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
two point discrimination test
Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale.
Measured: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
BCTQ SSS
The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms).
Measured: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start8 Sep 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tien-Ching Lee, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067205
- Sponsor's protocol ID
- CTS001
- Status last verified
- May 2023
- First submitted
- 8 Sep 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen HF, Chang SM, Kao CM, Chen YL, Kao LT, Hsu YC, Fu YC, Wang YH, Liu WC, Lee TC. Novel minimally invasive carpal tunnel release using a specialized surgical kit: a prospective multi-center case series. BMC Musculoskelet Disord. 2025 Apr 8;26(1):346. doi: 10.1186/s12891-025-08612-0.
PubMed 40200263
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Carpal Tunnel Decompression Using a Novel Ergonomic Releasing Instrument
- ClinicalTrials.gov ID
- NCT05067205
- Acronym / sponsor ID
- CTS001
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Oct 2021 (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.
This is a prospective, open-label, parallel-group, randomized controlled trial to evaluate the postoperative outcome after carpal tunnel release by using mini CTS releaser and open method with duration of 6 months estimated.
The study hypothesis is that mini CTS releaser can offer similar functional outcomes to the open approach and avoid the complications of the open surgery.
Detailed description
The current study is the first clinical trial of carpal tunnel syndrome treated by using a device - novel mini CTS releaser. The functional outcome and objective outcome will be recorded to prove the hypothesis that mini CTS releaser can offer similar functional outcomes to the open approach and decrease the complication rate in comparison of the open surgery.
When patients visit, the research physician confirms whether the eligibility criteria are met, and the physician verbally explains the research theme, purpose, and method of execution. After the patient's consent, he should sign the subject consent.
At baseline recruitment, a standardized in-person interview will be conducted by trained and certified study personnel according to structured questionnaires to obtain information on socio-demographic characteristics, habits of tobacco and alcohol use, peripheral blood sample will be also collected from each participant. All of the operated patients underwent a complete personal medical history review, detailed physical examination, as well as routine hematological tests.
Patients will be randomized 1:1 to mini CTS releaser group or to open release group. There will be 35 individuals in each treatment arm. The planned follow-up time will be scheduled.
Safety outcomes including adverse events and changes around surgical wound and neurologic sign will be recorded. Patients will be carefully observed and if any abnormality is noted, appropriate measures will be instituted. The surgical materials used are all certified by the Ministry of Health and Welfare in Taiwan. The possible side effects, such as infections or inflammatory reactions that may occur after surgery, will be given antibiotics or other appropriate treatments in accordance with standard medical procedures.
Data of baseline characteristics will be described using means with standard deviations (SDs) or medians and interquartile ranges (IQRs), or both for continuous variables and using frequencies (percentages) for categorical variables. Mean morphological measures (and changes) will be computed as averages across participants within each treatment group. Between-group baseline comparisons will be based on 2 independent two sample t test or Wilcoxon Mann-Whitney test for quantitative variables, and chi-square test or Fisher's exact test for categorical variables. P values less than 0.05 will be adjusted for multiple comparisons using Bonferroni correction. All statistical analyses will be performed using SAS software Version 9.4 (SAS Institute Inc., Cary, North Carolina).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open release | Sham comparator | Procedure: Carpal tunnel release surgeryA prospective, open-label, parallel-group to evaluate the postoperative outcome after carpal tunnel release by using open carpal tunnel release method with duration of 6 months estimated. |
| mini CTS releaser | Experimental | Procedure: Carpal tunnel release surgeryA prospective, open-label, parallel-group to evaluate the postoperative outcome after carpal tunnel release by using mini CTS releaser method with duration of 6 months estimated. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 years of age and above.
- clinically symptomatic and electrophysiologically confirmed carpal tunnel syndrome.
- no response to conservative treatment.
- Signed Informed Consent and willing to comply with doctors and nurses' order.
Key exclusion criteria (6 listed)
- Subjects with recurrent carpal tunnel syndrome
- Subjects with coexisting cervical radiculopathy
- Subjects treated with systemic immunosuppressive or glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisolone per day or equivalent.
- Diabetic patients with pre-OP HbA1c >7%
- Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
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 |
|---|---|---|
| Carpal tunnel release surgeryPreoperative, 3 days, 2 weeks, 4 weeks and 24 weeks postoperatively | Procedure or surgery | mini CTS releaser, open release |
Primary outcome
Change from preoperative BCTQ SSS at 4 Weeks
Time frame: preoperative and 4 weeks after surgery
The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) is an 11-question patient-administered survey that rates the severity of the patient's carpal tunnel syndrome-specific symptoms on a scale of 1 (no symptoms) to 5 (worst symptoms)
8 secondary outcomes
Operation time
Time frame: operation day
Wound size
Time frame: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
Grip/pinch strength
Time frame: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
Pain Scores on the Visual Analog Scale
Time frame: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
Time off work
Time frame: 24 weeks after surgery
Number of Participants with Adverse Events
Time frame: 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
two point discrimination test
Time frame: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
BCTQ SSS
Time frame: Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks after surgery
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 6 May 2023.
- Derived from this study: PubMed 40200263Chen HF, Chang SM, Kao CM, Chen YL, Kao LT, Hsu YC, Fu YC, Wang YH, Liu WC, Lee TC. Novel minimally invasive carpal tunnel release using a specialized surgical kit: a prospective multi-center case series. BMC Musculoskelet Disord. 2025 Apr 8;26(1):346. doi: 10.1186/s12891-025-08612-0.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal tunnel release surgery in people with Carpal Tunnel Syndrome, run by Kaohsiung Medical University at 1 site 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 4 inclusion and 6 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from preoperative BCTQ SSS at 4 Weeks (time frame: preoperative and 4 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067205, which also lists 1 linked publication.
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 6 May 2023.