Idiopathic Carpal Tunnel SyndromeNCT01972165
Comparison of Subjective Outcomes and Changes of Ultrasonographic Morphology of Median Nerves of Mini-open and Endoscopic Carpal Tunnel Release in Patients With Idiopathic Carpal Tunnel Syndrome
A study testing Mini-incision carpal tunnel release and Endoscopic carpal tunnel release in people with Idiopathic Carpal Tunnel Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
A few studies have shown that the mini-incision release technique decreases the pathologic swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening ratio of the median nerve in the carpal tunnel. Read more about this study
- Who is it for?
- Ages 27 to 82 years
- Conditions the study is for
- Idiopathic Carpal Tunnel Syndrome
- What is being tested?
- Mini-incision carpal tunnel release and Endoscopic carpal tunnel release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jul 2013
- 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 27 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 20 years or older.
- Patients with idiopathic CTS that was confirmed by electrodiagnostic tests
- Patients with idiopathic CTS who were scheduled for carpal tunnel release
Who cannot join
- Patients with a history of wrist-area fracture or dislocation
- Patients with previous carpal tunnel release
- Patients with associated cervical radiculopathy, cubital tunnel syndrome, thoracic outlet syndrome, diabetes mellitus, hypothyroidism, arthritis, or Burger's disease
- Patients with cognitive impairment that affected the patient's ability to complete the questionnaires
- Patients with worker's compensation issues
- Patients with inadequate follow-up (i.e., less than 24 weeks post-operation)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System
Seoul, 120-752
About this study
A few studies have shown that the mini-incision release technique decreases the pathologic swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic release technique similarly reverses these pathological changes in the median nerve along the carpal tunnel in patients with CTS compared with the mini-incision release.
Investigators therefore conducted the current study to compare the subjective outcomes and US-measured morphological changes in the median nerve in patients with CTS who received either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function scores and the DASH scores, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or endoscopic carpal tunnel release.
- Conditions
- Idiopathic Carpal Tunnel Syndrome
- Being tested
- Mini-incision carpal tunnel release, Endoscopic carpal tunnel release
- 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.
Mini-incision carpal tunnel releaseProcedure or surgery
Endoscopic carpal tunnel releaseProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Mini-incision carpal tunnel release group Receives: Procedure: Mini-incision carpal tunnel release |
| Group II | Active comparator | Endoscopic carpal tunnel release group Receives: Procedure: Endoscopic carpal tunnel release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
The BCTQ is a disease-specific status scale that incorporates both a symptom severity scale and a functional scale. The symptom severity scale (BCTQ-S) is comprised of eleven items that address the severity, frequency, and duration of symptoms, whereas the functional status scale (BCTQ-F) is comprised of eight questions that assess the difficulty of performing eight daily tasks. Each question offers five possible responses of increasing severity, which are scored from 1 (none) to 5 (most severe); the mean values of all the items in the BCTQ were calculated.
Measured: preoperatively and 24 weeks post-operation
Secondary outcomes (1)
Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
The DASH quantifies general disabilities related to the upper extremity. The questionnaire contains 30 items: 21 questions that assess difficulties with specific tasks, five that evaluate symptoms, and four that evaluate social function, work function, sleep, and confidence. The DASH scores are scaled between 0 and 100 with higher scores representing greater upper extremity disability.
Measured: preoperatively and 24 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJul 2013
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 Idiopathic Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972165
- Sponsor's protocol ID
- 1-2011-0072
- Status last verified
- Oct 2013
- First submitted
- 18 Oct 2013
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Oh WT, Kang HJ, Koh IH, Jang JY, Choi YR. Morphologic change of nerve and symptom relief are similar after mini-incision and endoscopic carpal tunnel release: a randomized trial. BMC Musculoskelet Disord. 2017 Feb 3;18(1):65. doi: 10.1186/s12891-017-1438-z.
PubMed 28158978
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subjective Outcomes and Changes of Ultrasonographic Morphology of Median Nerves of Mini-open and Endoscopic Carpal Tunnel Release in Patients With Idiopathic Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT01972165
- Acronym / sponsor ID
- 1-2011-0072
- Conditions
- Idiopathic Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Oct 2013 (estimated)
- 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.
A few studies have shown that the mini-incision release technique decreases the pathologic swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic release technique similarly reverses these pathological changes in the median nerve along the carpal tunnel in patients with CTS compared with the mini-incision release.
Investigators therefore conducted the current study to compare the subjective outcomes and US-measured morphological changes in the median nerve in patients with CTS who received either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function scores and the DASH scores, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or endoscopic carpal tunnel release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Mini-incision carpal tunnel releaseMini-incision carpal tunnel release group |
| Group II | Active comparator | Procedure: Endoscopic carpal tunnel releaseEndoscopic carpal tunnel release group |
Who may qualify
- Ages
- 27 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are 20 years or older.
- Patients with idiopathic CTS that was confirmed by electrodiagnostic tests
- Patients with idiopathic CTS who were scheduled for carpal tunnel release
Key exclusion criteria (6 listed)
- Patients with a history of wrist-area fracture or dislocation
- Patients with previous carpal tunnel release
- Patients with associated cervical radiculopathy, cubital tunnel syndrome, thoracic outlet syndrome, diabetes mellitus, hypothyroidism, arthritis, or Burger's disease
- Patients with cognitive impairment that affected the patient's ability to complete the questionnaires
- Patients with worker's compensation issues
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 |
|---|---|---|
| Mini-incision carpal tunnel release | Procedure or surgery | Group I |
| Endoscopic carpal tunnel release | Procedure or surgery | Group II |
Primary outcome
Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: preoperatively and 24 weeks post-operation
The BCTQ is a disease-specific status scale that incorporates both a symptom severity scale and a functional scale. The symptom severity scale (BCTQ-S) is comprised of eleven items that address the severity, frequency, and duration of symptoms, whereas the functional status scale (BCTQ-F) is comprised of eight questions that assess the difficulty of performing eight daily tasks. Each question offers five possible responses of increasing severity, which are scored from 1 (none) to 5 (most severe); the mean values of all the items in the BCTQ were calculated.
1 secondary outcome
Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time frame: preoperatively and 24 weeks post-operation
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 30 Oct 2013.
- Derived from this study: PubMed 28158978Oh WT, Kang HJ, Koh IH, Jang JY, Choi YR. Morphologic change of nerve and symptom relief are similar after mini-incision and endoscopic carpal tunnel release: a randomized trial. BMC Musculoskelet Disord. 2017 Feb 3;18(1):65. doi: 10.1186/s12891-017-1438-z.
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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 Mini-incision carpal tunnel release and Endoscopic carpal tunnel release in people with Idiopathic Carpal Tunnel Syndrome, run by Yonsei University at 1 site in South Korea.
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 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 30 Oct 2013. 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 South Korea. 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. 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 of the Boston Carpal Tunnel Questionnaire (BCTQ) (time frame: preoperatively and 24 weeks post-operation). 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 NCT01972165, 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 30 Oct 2013.