Evaluation by Clinical and Hand Ultrasound in Carpal Tunnel Syndrome

NCT07134361 | Recruiting

• 1 other identifier: 86571525.4.0000.0068
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Carpal Tunnel Syndrome (CTS); Carpal Tunnel Surgery

Keywords

carpal tunnel syndromes; Median Neuropathy; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (preoperative) and at 3 and 6 months post-surgery

Secondary Outcomes (4)

• Change in Boston Carpal Tunnel Questionnaire (BCTQ) scores

  Baseline (preoperative) and at 3 and 6 months post-surgery

• Change in QuickDASH scores

  Baseline (preoperative) and at 3 and 6 months post-surgery

• Change in grip and pinch strength

  Baseline (preoperative) and at 3 and 6 months post-surgery

• Change in tactile sensitivity using Semmes-Weinstein monofilaments.

  Baseline (preoperative) and at 3 and 6 months post-surgery

Study Arms (1)

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.

Procedure: Open Carpal Tunnel Release

Interventions

Open Carpal Tunnel Release PROCEDURE

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.

Surgical Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05402-000, Brazil

RECRUITING

Related Publications (5)

• 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.

  PMID: 32643958 BACKGROUND

• Jansen 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.

  PMID: 34353640 BACKGROUND

• Cavalcante 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.

  PMID: 36541951 BACKGROUND

• Katz 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.

  PMID: 2306060 BACKGROUND

• Kim 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.

  PMID: 27583113 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Marcelo Rosa Rezende, MD, PhD,

  HOSPITAL DAS CLÍNICAS DA FACULDADE DE MEDICINA DA UNIVERSIDADE DE SÃO PAULO (HCFM/USP)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joao Carlos Rodrigues, MD, PhD

CONTACT

+55112661-6909; joao.r@hc.fm.usp.br

Marcelo Rosa Rezende, MD, PhD

CONTACT

+55112661-6909; marcelo.rezende@ hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication of the primary results and available for 3 years.
• Access Criteria: Data will be made available to researchers whose proposed use of the data has been approved by an independent review committee (data access committee). Access requests should include a methodologically sound proposal and will be evaluated for scientific merit and ethical compliance.

Locations

BR (1)