Hand ultrasound and clinical follow-up after carpal tunnel release
Clinical Analysis and Ultrasound Evaluation of the Median Nerve Cross-sectional Area Before and After Carpal Tunnel Release
This project will try to see if changes in median nerve size on hand ultrasound after open carpal tunnel release match how people's symptoms, sensation, and strength improve over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07134361 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of patients with primary carpal tunnel syndrome undergoing standardized open carpal tunnel release at a tertiary university hospital. High-resolution ultrasound will measure median nerve cross-sectional area at the carpal tunnel inlet and outlet before surgery and at 3 and 6 months after surgery. Patients will also complete the Boston Carpal Tunnel Questionnaire and QuickDASH and undergo grip/pinch strength and tactile sensibility testing at the same time points. The study aims to link morphological changes on ultrasound with functional and symptomatic recovery and to identify prognostic factors for improvement.
Who should consider this trial
Good fit: Adults with primary carpal tunnel syndrome who are scheduled for open carpal tunnel release and have a baseline median nerve cross-sectional area greater than 10 mm² are ideal candidates.
Not a fit: People with secondary causes of carpal tunnel syndrome, prior carpal tunnel release on the affected hand, or other peripheral neuropathies are excluded and unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, this could help clinicians use ultrasound findings to monitor healing and better predict which patients will recover faster after surgery.
How similar studies have performed: Prior work shows ultrasound can detect median nerve enlargement and correlate with symptoms, but longitudinal associations between post-surgical ultrasound changes and recovery are less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
São Paulo, São Paulo
- Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da FMUSP — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Marcelo Rosa Rezende, MD, PhD, — Hospital Das Clínicas Da Faculdade de Medicina Da Universidade de São Paulo (Hcfm/usp)
- Study coordinator: Joao Carlos Rodrigues, MD, PhD
- Email: joao.r@hc.fm.usp.br
- Phone: +55112661-6909
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.