Carpal Tunnel Syndrome (CTS)ECHO-CTSNCT07134361
Evaluation by Clinical and Hand Ultrasound in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS) and Carpal Tunnel Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Carpal Tunnel Syndrome (CTS) is a common condition where pressure on the median nerve in the wrist causes pain, numbness, and weakness in the hand. Surgery to release the carpal tunnel is often performed to relieve these symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Carpal Tunnel Surgery
- What is being tested?
- Open Carpal Tunnel Release
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jun 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from patients referred to the Hand Surgery and Microsurgery Department at Hospital das Clínicas, a tertiary care academic hospital affiliated with the University of São Paulo Medical School in São Paulo, Brazil.
Who may be able to join
- Clinical diagnosis of primary carpal tunnel syndrome (CTS), confirmed by characteristic symptoms, physical examination findings, and a cross-sectional area superior to 10 mm² in the ultrasonography baseline.
- Indication for open carpal tunnel release as part of routine clinical care.
Who cannot join
- Secondary CTS due to inflammatory arthritis, prior wrist trauma, or space-occupying lesions.
- History of previous carpal tunnel release in the affected hand.
- Concomitant peripheral neuropathies (e.g., diabetic polyneuropathy) or cervical radiculopathy
- Inability to undergo ultrasound assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 05402-000
Marcelo Rosa Rezende, MD, PhD, +55 11 2661-6909, marcelo.rezende@hc.fm.usp.br
João Carlos Rodrigues, MD, PhD, +55 11 2661-6909, joao.r@hc.fm.usp.br
About this study
Official title: Clinical Analysis and Ultrasound Evaluation of the Median Nerve Cross-sectional Area Before and After Carpal Tunnel Release
Carpal Tunnel Syndrome (CTS) is a common condition where pressure on the median nerve in the wrist causes pain, numbness, and weakness in the hand. Surgery to release the carpal tunnel is often performed to relieve these symptoms.
This study will evaluate the changes in the median nerve after surgery and how these changes relate to symptom improvement. Investigators will use ultrasound imaging to measure the nerve size before and at three and six months after surgery. Patients will also complete questionnaires about their symptoms and hand function, and undergo tests to assess strength and sensation.
The investigator's goal is to determine whether changes observed on ultrasound are associated with the rate of patient recovery. This may help doctors better monitor healing and improve care for people with CTS.
Read the detailed description
This is a prospective observational cohort study designed to evaluate structural and functional recovery in patients with primary carpal tunnel syndrome undergoing open carpal tunnel release. The study also aims to identify prognostic factors associated with clinical and functional improvement after surgery. Patients will be consecutively recruited from the Hand Surgery and Microsurgery Department of a tertiary University Hospital.
All participants will undergo a standardized surgical procedure performed by experienced hand surgeons as part of routine clinical care. Ultrasonographic assessments of the median nerve cross-sectional area (CSA) at the carpal tunnel inlet and outlet will be conducted by an experienced radiologist using a high-resolution linear transducer (7-16 MHz) at three time points: preoperatively, and at 3 and 6 months after surgery. Secondary outcomes, including the Boston Carpal Tunnel Questionnaire (BCTQ), QuickDASH, quantitative grip and pinch strength measured with calibrated dynamometers, and tactile sensibility testing with Semmes-Weinstein monofilaments, will be assessed at the same time points by an occupational therapist specializing in hand therapy. This evaluation schedule is designed to characterize both morphological and functional recovery after surgery longitudinally.
The primary outcome is the change in median nerve CSA between baseline and follow-up. Secondary outcomes include changes in BCTQ and QuickDASH scores, grip strength, pinch strength, and sensory thresholds. All analyses will be two-sided with an alpha level of 0.05 and 95% confidence intervals. Data normality will be assessed with the Shapiro-Wilk test. Continuous outcomes will be compared pre- and postoperatively using paired t-tests or Wilcoxon signed-rank tests, as appropriate. Associations between CSA change and secondary outcomes will be examined with univariate and multivariable linear regression, adjusting for age, sex, symptom duration, and dominant hand involvement, with interaction terms to assess potential effect modification. Exploratory subgroup analyses for age, sex, and symptom duration will follow the same statistical approach, and categorical variables, if applicable, will be compared using Chi-square or Fisher's exact tests.
The prognostic value of baseline CSA will be explored using receiver operating characteristic (ROC) curve analysis for clinically meaningful improvement in secondary outcomes at 3 and 6 months. The Youden index will determine the optimal cutoff, and the area under the curve (AUC) will quantify discriminative ability. This cutoff will then stratify patients for exploratory comparisons over time. The sample size was calculated for a paired comparison of pre- and postoperative CSA, assuming a mean detectable difference of 1.0 mm² and a standard deviation of paired differences of 3.29 mm², with an alpha level of 0.05 and 80% power. This yields a requirement of 85 patients; allowing for 20% missingness, the final target is 107 participants.
All analyses will be performed using MedCalc version 23.2.7 (64-bit). Standardized protocols will be applied for all assessments, with regular data validation, source-data verification against medical records, and maintenance of a detailed data dictionary. Standard Operating Procedures will guide recruitment, data collection, and management. Missing data will be addressed using appropriate statistical methods such as multiple imputation or sensitivity analyses, depending on the mechanism and extent of missingness. No experimental interventions will be introduced; the study is observational in nature. Results will contribute to improved understanding of prognostic indicators in carpal tunnel syndrome and support evidence-based postoperative monitoring.
- Being tested
- Open Carpal Tunnel Release
- Keywords
- carpal tunnel syndromes, Median Neuropathy, Ultrasonography
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Carpal Tunnel ReleaseProcedure or surgery
All patients included in the cohort will undergo open carpal tunnel release as part of routine clinical care. The study does not assign the surgical procedure as an investigational intervention; however, it will observe clinical and ultrasonographic outcomes before and after surgery to assess prognostic factors.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Patients diagnosed with primary carpal tunnel syndrome (CTS) are undergoing open carpal tunnel release as part of their routine clinical care. The surgical procedure is not assigned by the study but performed according to standard practice. The cohort will be followed prospectively with clinical assessments (Boston Carpal Tunnel Questionnaire, QuickDASH, grip and pinch strength, Semmes-Weinstein monofilament testing), as well as ultrasonographic evaluation of the median nerve cross-sectional area, before and at three and six months after surgery, to identify prognostic factors associated with functional and symptomatic recovery. Receives: Procedure: Open Carpal Tunnel Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in median nerve cross-sectional area (CSA) measured by high-resolution ultrasound
The CSA of the median nerve will be assessed at two standardized locations: the carpal tunnel inlet and the carpal tunnel outlet. Measurements will be obtained using a high-frequency linear transducer (7-16 MHz) with the patient seated, forearm resting, and wrist in neutral position. The CSA will be calculated by manually tracing the inner border of the epineurium on transverse images. Assessments will be performed preoperatively and at three and six months postoperatively. The aim is to evaluate structural changes in the median nerve after carpal tunnel release and correlate them with clinical recovery.
Measured: Baseline (preoperative) and at 3 and 6 months post-surgery
Secondary outcomes (4)
Change in Boston Carpal Tunnel Questionnaire (BCTQ) scores
The Boston Carpal Tunnel Questionnaire will be used to assess symptom severity (BCTQ-S) and functional status (BCTQ-F). Each subscale score ranges from 1 (no symptoms or limitations) to 5 (severe symptoms or limitations). Scores will be calculated as the mean of items in each subscale.
Measured: Baseline (preoperative) and at 3 and 6 months post-surgery
Change in QuickDASH scores
The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire measures upper limb disability and symptoms. Scores range from 0 (no disability) to 100 (most severe disability).
Measured: Baseline (preoperative) and at 3 and 6 months post-surgery
Change in grip and pinch strength
Grip and pinch strength will be measured using a calibrated hand dynamometer and pinch gauge, respectively. Tests will be performed with the participant seated, with the shoulder adducted, the elbow at 90°, and the forearm in a neutral position. The highest value from the three trials will be recorded for each hand.
Measured: Baseline (preoperative) and at 3 and 6 months post-surgery
Change in tactile sensitivity using Semmes-Weinstein monofilaments.
Sensory function will be evaluated using Semmes-Weinstein monofilaments applied to median nerve-innervated areas of the hand. Threshold levels will be classified according to standard color coding (green to red).
Measured: Baseline (preoperative) and at 3 and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start25 Jun 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo Rosa de Rezende, University of Sao Paulo General Hospital
- Investigators
- Marcelo Rosa Rezende, MD, PhD,, Principal investigator, HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO (HCFM/USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134361
- Sponsor's protocol ID
- 86571525.4.0000.0068
- Acronym
- ECHO-CTS
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in the publication (after de-identification) will be shared. This includes clinical and ultrasonographic data collected before and after surgery. Supporting documents such as the study protocol, statistical analysis plan, and analytic code will also be available upon request. Data sharing will comply with ethical approvals and patient consent requirements.
Publications
Tajika T, Kuboi T, Endo F, Chikuda H. Relationship Between Morphological Change of Median Nerve and Clinical Outcome Before and After Open Carpal Tunnel Release: Ultrasonographic 1-Year Follow-up After Operation. Hand (N Y). 2022 May;17(3):534-539. doi: 10.1177/1558944720937367. Epub 2020 Jul 9.
PubMed 32643958Jansen MC, Duraku LS, Hundepool CA, Power DM, Rajaratnam V, Selles RW, Zuidam JM. Management of Recurrent Carpal Tunnel Syndrome: Systematic Review and Meta-Analysis. J Hand Surg Am. 2022 Apr;47(4):388.e1-388.e19. doi: 10.1016/j.jhsa.2021.05.007. Epub 2021 Aug 3.
PubMed 34353640Cavalcante MC, Moraes VY, Oses GL, Nakachima LR, Belloti JC. Quality analysis of prior systematic reviews of carpal tunnel syndrome: an overview of the literature. Sao Paulo Med J. 2022 Dec 19;141(5):e20211020. doi: 10.1590/1516-3180.2021.1020.R2.10102022. eCollection 2022.
PubMed 36541951Katz JN, Larson MG, Sabra A, Krarup C, Stirrat CR, Sethi R, Eaton HM, Fossel AH, Liang MH. The carpal tunnel syndrome: diagnostic utility of the history and physical examination findings. Ann Intern Med. 1990 Mar 1;112(5):321-7. doi: 10.7326/0003-4819-112-5-321.
PubMed 2306060Kim JK, Koh YD, Kim JO, Choi SW. Changes in Clinical Symptoms, Functions, and the Median Nerve Cross-Sectional Area at the Carpal Tunnel Inlet after Open Carpal Tunnel Release. Clin Orthop Surg. 2016 Sep;8(3):298-302. doi: 10.4055/cios.2016.8.3.298. Epub 2016 Aug 10.
PubMed 27583113
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis and Ultrasound Evaluation of the Median Nerve Cross-sectional Area Before and After Carpal Tunnel Release
- ClinicalTrials.gov ID
- NCT07134361
- Acronym / sponsor ID
- ECHO-CTS / 86571525.4.0000.0068
- Keywords
- carpal tunnel syndromes, Median Neuropathy, Ultrasonography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Aug 2025 (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.
Carpal Tunnel Syndrome (CTS) is a common condition where pressure on the median nerve in the wrist causes pain, numbness, and weakness in the hand. Surgery to release the carpal tunnel is often performed to relieve these symptoms.
This study will evaluate the changes in the median nerve after surgery and how these changes relate to symptom improvement. Investigators will use ultrasound imaging to measure the nerve size before and at three and six months after surgery. Patients will also complete questionnaires about their symptoms and hand function, and undergo tests to assess strength and sensation.
The investigator's goal is to determine whether changes observed on ultrasound are associated with the rate of patient recovery. This may help doctors better monitor healing and improve care for people with CTS.
Detailed description
This is a prospective observational cohort study designed to evaluate structural and functional recovery in patients with primary carpal tunnel syndrome undergoing open carpal tunnel release. The study also aims to identify prognostic factors associated with clinical and functional improvement after surgery. Patients will be consecutively recruited from the Hand Surgery and Microsurgery Department of a tertiary University Hospital.
All participants will undergo a standardized surgical procedure performed by experienced hand surgeons as part of routine clinical care. Ultrasonographic assessments of the median nerve cross-sectional area (CSA) at the carpal tunnel inlet and outlet will be conducted by an experienced radiologist using a high-resolution linear transducer (7-16 MHz) at three time points: preoperatively, and at 3 and 6 months after surgery. Secondary outcomes, including the Boston Carpal Tunnel Questionnaire (BCTQ), QuickDASH, quantitative grip and pinch strength measured with calibrated dynamometers, and tactile sensibility testing with Semmes-Weinstein monofilaments, will be assessed at the same time points by an occupational therapist specializing in hand therapy. This evaluation schedule is designed to characterize both morphological and functional recovery after surgery longitudinally.
The primary outcome is the change in median nerve CSA between baseline and follow-up. Secondary outcomes include changes in BCTQ and QuickDASH scores, grip strength, pinch strength, and sensory thresholds. All analyses will be two-sided with an alpha level of 0.05 and 95% confidence intervals. Data normality will be assessed with the Shapiro-Wilk test. Continuous outcomes will be compared pre- and postoperatively using paired t-tests or Wilcoxon signed-rank tests, as appropriate. Associations between CSA change and secondary outcomes will be examined with univariate and multivariable linear regression, adjusting for age, sex, symptom duration, and dominant hand involvement, with interaction terms to assess potential effect modification. Exploratory subgroup analyses for age, sex, and symptom duration will follow the same statistical approach, and categorical variables, if applicable, will be compared using Chi-square or Fisher's exact tests.
The prognostic value of baseline CSA will be explored using receiver operating characteristic (ROC) curve analysis for clinically meaningful improvement in secondary outcomes at 3 and 6 months. The Youden index will determine the optimal cutoff, and the area under the curve (AUC) will quantify discriminative ability. This cutoff will then stratify patients for exploratory comparisons over time. The sample size was calculated for a paired comparison of pre- and postoperative CSA, assuming a mean detectable difference of 1.0 mm² and a standard deviation of paired differences of 3.29 mm², with an alpha level of 0.05 and 80% power. This yields a requirement of 85 patients; allowing for 20% missingness, the final target is 107 participants.
All analyses will be performed using MedCalc version 23.2.7 (64-bit). Standardized protocols will be applied for all assessments, with regular data validation, source-data verification against medical records, and maintenance of a detailed data dictionary. Standard Operating Procedures will guide recruitment, data collection, and management. Missing data will be addressed using appropriate statistical methods such as multiple imputation or sensitivity analyses, depending on the mechanism and extent of missingness. No experimental interventions will be introduced; the study is observational in nature. Results will contribute to improved understanding of prognostic indicators in carpal tunnel syndrome and support evidence-based postoperative monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Cohort | – | Procedure: Open Carpal Tunnel ReleasePatients diagnosed with primary carpal tunnel syndrome (CTS) are undergoing open carpal tunnel release as part of their routine clinical care. The surgical procedure is not assigned by the study but performed according to standard practice. The cohort will be followed prospectively with clinical assessments (Boston Carpal Tunnel Questionnaire, QuickDASH, grip and pinch strength, Semmes-Weinstein monofilament testing), as well as ultrasonographic evaluation of the median nerve cross-sectional area, before and at three and six months after surgery, to identify prognostic factors associated with functional and symptomatic recovery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from patients referred to the Hand Surgery and Microsurgery Department at Hospital das Clínicas, a tertiary care academic hospital affiliated with the University of São Paulo Medical School in São Paulo, Brazil.
Key inclusion criteria (2 listed)
- Clinical diagnosis of primary carpal tunnel syndrome (CTS), confirmed by characteristic symptoms, physical examination findings, and a cross-sectional area superior to 10 mm² in the ultrasonography baseline.
- Indication for open carpal tunnel release as part of routine clinical care.
Key exclusion criteria (4 listed)
- Secondary CTS due to inflammatory arthritis, prior wrist trauma, or space-occupying lesions.
- History of previous carpal tunnel release in the affected hand.
- Concomitant peripheral neuropathies (e.g., diabetic polyneuropathy) or cervical radiculopathy
- Inability to undergo ultrasound assessment
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 |
|---|---|---|
| Open Carpal Tunnel ReleaseAll patients included in the cohort will undergo open carpal tunnel release as part of routine clinical care. The study does not assign the surgical procedure as an investigational intervention; however, it will observe clinical and ultrasonographic outcomes before and after surgery to assess prognostic factors. | Procedure or surgery | Surgical Cohort |
Primary outcome
Change in median nerve cross-sectional area (CSA) measured by high-resolution ultrasound
Time frame: Baseline (preoperative) and at 3 and 6 months post-surgery
The CSA of the median nerve will be assessed at two standardized locations: the carpal tunnel inlet and the carpal tunnel outlet. Measurements will be obtained using a high-frequency linear transducer (7-16 MHz) with the patient seated, forearm resting, and wrist in neutral position. The CSA will be calculated by manually tracing the inner border of the epineurium on transverse images. Assessments will be performed preoperatively and at three and six months postoperatively. The aim is to evaluate structural changes in the median nerve after carpal tunnel release and correlate them with clinical recovery.
4 secondary outcomes
Change in Boston Carpal Tunnel Questionnaire (BCTQ) scores
Time frame: Baseline (preoperative) and at 3 and 6 months post-surgery
Change in QuickDASH scores
Time frame: Baseline (preoperative) and at 3 and 6 months post-surgery
Change in grip and pinch strength
Time frame: Baseline (preoperative) and at 3 and 6 months post-surgery
Change in tactile sensitivity using Semmes-Weinstein monofilaments.
Time frame: Baseline (preoperative) and at 3 and 6 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 32643958Tajika T, Kuboi T, Endo F, Chikuda H. Relationship Between Morphological Change of Median Nerve and Clinical Outcome Before and After Open Carpal Tunnel Release: Ultrasonographic 1-Year Follow-up After Operation. Hand (N Y). 2022 May;17(3):534-539. doi: 10.1177/1558944720937367. Epub 2020 Jul 9.
- Background: PubMed 34353640Jansen MC, Duraku LS, Hundepool CA, Power DM, Rajaratnam V, Selles RW, Zuidam JM. Management of Recurrent Carpal Tunnel Syndrome: Systematic Review and Meta-Analysis. J Hand Surg Am. 2022 Apr;47(4):388.e1-388.e19. doi: 10.1016/j.jhsa.2021.05.007. Epub 2021 Aug 3.
- Background: PubMed 36541951Cavalcante MC, Moraes VY, Oses GL, Nakachima LR, Belloti JC. Quality analysis of prior systematic reviews of carpal tunnel syndrome: an overview of the literature. Sao Paulo Med J. 2022 Dec 19;141(5):e20211020. doi: 10.1590/1516-3180.2021.1020.R2.10102022. eCollection 2022.
- Background: PubMed 2306060Katz JN, Larson MG, Sabra A, Krarup C, Stirrat CR, Sethi R, Eaton HM, Fossel AH, Liang MH. The carpal tunnel syndrome: diagnostic utility of the history and physical examination findings. Ann Intern Med. 1990 Mar 1;112(5):321-7. doi: 10.7326/0003-4819-112-5-321.
- Background: PubMed 27583113Kim JK, Koh YD, Kim JO, Choi SW. Changes in Clinical Symptoms, Functions, and the Median Nerve Cross-Sectional Area at the Carpal Tunnel Inlet after Open Carpal Tunnel Release. Clin Orthop Surg. 2016 Sep;8(3):298-302. doi: 10.4055/cios.2016.8.3.298. Epub 2016 Aug 10.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in the publication (after de-identification) will be shared. This includes clinical and ultrasonographic data collected before and after surgery. Supporting documents such as the study protocol, statistical analysis plan, and analytic code will also be available upon request. Data sharing will comply with ethical approvals and patient consent requirements.
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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.
Marcelo Rosa Rezende, MD, PhD, principal investigator
HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO (HCFM/USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome (CTS) and Carpal Tunnel Surgery, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joao Carlos Rodrigues, MD, PhD (+55112661-6909, joao.r@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in median nerve cross-sectional area (CSA) measured by high-resolution ultrasound (time frame: Baseline (preoperative) and at 3 and 6 months post-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 NCT07134361, which also lists 5 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 28 Aug 2025.