Carpal Tunnel SyndromeNCT05094778
A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release
A study testing a single-portal palm approach in people with Carpal Tunnel Syndrome, run by Shenzhen People's Hospital.
Trial summary
Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- a single-portal palm approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2012to 30 Aug 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of carpal tunnel syndrome based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand
- Symptoms of carpal tunnel syndrome had lasted>2 months or inadequate responses to the non-surgical treatments≥3 months
- moderate to severe symptoms.
Who cannot join
- mild symptoms or prior injuries to the extremity
- bilateral wrists involved, a combined nerve compression, gout, diabetes or chronic renal failure.
About this study
Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. The investigators will compared the technique with the standard dual-portal endoscopic technique.
Read the detailed description
Conduct a multi-center, comparison clinical trial according to clinical Trial Reporting Standards (CONSORT). Patients in the single-portal group were treated with a single-portal palm approach that passes superficially to palmar aponeurosis and cut the full transverse carpal ligament. The comparison group were treated with Chow endoscopic technique. In order to assess efficiency of single-portal palm approach, the investigators will compared the technique with the standard dual-portal endoscopic technique. The study was approved by Shenzhen People's Hospital and informed consent was signed.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- a single-portal palm approach
- Keywords
- Carpal tunnel syndrome, carpal tunnel release, pain, nerve compression syndromes
- Medical subject headings
- Carpal Tunnel Syndrome, Pain, Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a single-portal palm approachProcedure or surgery
a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.
| Study group | Role | What they receive |
|---|---|---|
| single-portal group | Other | The patients in single-portal group were treated with single-portal palm approach Receives: Procedure: a single-portal palm approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensibility of the pulps of thumb, index finger, and middle finger (mm)
static 2-point discrimination (2PD) test is used for testing the sensibility of the pulps of digits. The range of normal value is 3 mm--5 mm, and higher scores mean a worse outcome
Measured: 3 years
Severity of symptoms and functional status
The Levine Questionnaire is regarded as a valuable assessment of severity of symptoms and functional status in carpal tunnel syndrome. It is self-administered and is in two sections. The symptoms severity scale is 11 questions and evaluates symptoms regarding severity, frequency, time and kind. The functional status scale is eight questions and evaluates how the syndrome affects daily life.Each question had five ordinal response categories ranging from 1 (no symptoms) to 5 (very severe symptoms). Responses to individual items were averaged to yield an overall score for each scale.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start5 Jan 2012
- Primary completion15 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Medical University Third Hospital
- Responsible party
- Sponsor
- Investigators
- Yongqing Zhuang, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094778
- Sponsor's protocol ID
- ShenzhenPH Zhuang03
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi Q, Bobos P, Lalone EA, Warren L, MacDermid JC. Comparison of the Short-Term and Long-Term Effects of Surgery and Nonsurgical Intervention in Treating Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Hand (N Y). 2020 Jan;15(1):13-22. doi: 10.1177/1558944718787892. Epub 2018 Jul 17.
PubMed 30015499Wei R, Chen C, Liu Y, Liu Z, Xiong H, Zhang X, Zhuang Y. Endoscopic Release Superficial Rather Than Deep to the Transverse Carpal Ligament for Carpal Tunnel Syndrome Improves Immediate Postoperative Transient Symptomatic Exacerbation With Fewer Absences From Work. Arthroscopy. 2023 Apr;39(4):963-970.e2. doi: 10.1016/j.arthro.2022.09.013. Epub 2022 Oct 5.
PubMed 36208712
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT05094778
- Acronym / sponsor ID
- ShenzhenPH Zhuang03
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, carpal tunnel release, pain, nerve compression syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Collaborators
- Hebei Medical University Third Hospital
- Study start
- 5 Jan 2012 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 26 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.
Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. The investigators will compared the technique with the standard dual-portal endoscopic technique.
Detailed description
Conduct a multi-center, comparison clinical trial according to clinical Trial Reporting Standards (CONSORT). Patients in the single-portal group were treated with a single-portal palm approach that passes superficially to palmar aponeurosis and cut the full transverse carpal ligament. The comparison group were treated with Chow endoscopic technique. In order to assess efficiency of single-portal palm approach, the investigators will compared the technique with the standard dual-portal endoscopic technique. The study was approved by Shenzhen People's Hospital and informed consent was signed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-portal group | Other | Procedure: a single-portal palm approachThe patients in single-portal group were treated with single-portal palm approach |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A confirmed diagnosis of carpal tunnel syndrome based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand
- Symptoms of carpal tunnel syndrome had lasted>2 months or inadequate responses to the non-surgical treatments≥3 months
- moderate to severe symptoms.
Key exclusion criteria (2 listed)
- mild symptoms or prior injuries to the extremity
- bilateral wrists involved, a combined nerve compression, gout, diabetes or chronic renal failure.
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 |
|---|---|---|
| a single-portal palm approacha single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. | Procedure or surgery | single-portal group |
Primary outcome
The sensibility of the pulps of thumb, index finger, and middle finger (mm)
Time frame: 3 years
static 2-point discrimination (2PD) test is used for testing the sensibility of the pulps of digits. The range of normal value is 3 mm--5 mm, and higher scores mean a worse outcome
Severity of symptoms and functional status
Time frame: 3 years
The Levine Questionnaire is regarded as a valuable assessment of severity of symptoms and functional status in carpal tunnel syndrome. It is self-administered and is in two sections. The symptoms severity scale is 11 questions and evaluates symptoms regarding severity, frequency, time and kind. The functional status scale is eight questions and evaluates how the syndrome affects daily life.Each question had five ordinal response categories ranging from 1 (no symptoms) to 5 (very severe symptoms). Responses to individual items were averaged to yield an overall score for each scale.
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 26 Oct 2021.
- Results publication: PubMed 30015499Shi Q, Bobos P, Lalone EA, Warren L, MacDermid JC. Comparison of the Short-Term and Long-Term Effects of Surgery and Nonsurgical Intervention in Treating Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Hand (N Y). 2020 Jan;15(1):13-22. doi: 10.1177/1558944718787892. Epub 2018 Jul 17.
- Derived from this study: PubMed 36208712Wei R, Chen C, Liu Y, Liu Z, Xiong H, Zhang X, Zhuang Y. Endoscopic Release Superficial Rather Than Deep to the Transverse Carpal Ligament for Carpal Tunnel Syndrome Improves Immediate Postoperative Transient Symptomatic Exacerbation With Fewer Absences From Work. Arthroscopy. 2023 Apr;39(4):963-970.e2. doi: 10.1016/j.arthro.2022.09.013. Epub 2022 Oct 5.
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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.
Yongqing Zhuang principal investigator
Shenzhen People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing a single-portal palm approach in people with Carpal Tunnel Syndrome, run by Shenzhen People's Hospital.
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 3 inclusion and 2 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The sensibility of the pulps of thumb, index finger, and middle finger (mm) (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT05094778, which also lists 2 linked publications.
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 26 Oct 2021.