Actively Recruiting

Age: 18Years +
All Genders
ID07134361

Clinical Analysis and Ultrasound Evaluation of the Median Nerve Cross-sectional Area Before and After Carpal Tunnel Release

Led by University of Sao Paulo General Hospital · Updated on 2025-08-28

106

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. Researchers are studying how the median nerve changes after surgery and how these changes relate to symptom improvement. The study focuses on patients undergoing open carpal tunnel release to better understand recovery and improve monitoring after surgery. Patients will have ultrasound scans to measure the median nerve size before surgery and again at three and six months afterward. They will also complete questionnaires about their symptoms and hand function, and undergo tests measuring grip and pinch strength as well as sensation. All surgeries are performed by experienced hand surgeons as part of routine care, and the study observes these outcomes without assigning treatments. Participants will be evaluated at three time points: before surgery, and at three and six months after surgery. Assessments include ultrasound imaging, symptom questionnaires, strength tests, and sensory evaluations. Researchers will analyze changes in nerve size and their relationship to functional recovery and patient symptoms to identify factors that predict improvement. The study aims to support better evidence-based monitoring for CTS patients after surgery.

CONDITIONS

Brief Title

Evaluation by Clinical and Hand Ultrasound in Carpal Tunnel Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of primary carpal tunnel syndrome confirmed by symptoms, physical examination, and ultrasound showing nerve cross-sectional area over 10 mm�b2
  • Indication for open carpal tunnel release as part of routine clinical care
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Secondary carpal tunnel syndrome due to inflammatory arthritis, prior wrist trauma, or space-occupying lesions
  • Previous carpal tunnel release surgery on the affected hand
  • Other peripheral neuropathies such as diabetic polyneuropathy or cervical radiculopathy
  • Inability to undergo ultrasound assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo open carpal tunnel release surgery as part of their routine clinical care.

1 surgical visit

Post-operative Follow-up

Duration - 6 months

Participants receive assessments of median nerve ultrasound and clinical function to monitor recovery after surgery.

3 visits at preoperative baseline, 3 months, and 6 months post-surgery

Trial Site Locations

Total: 1 location

1

Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil, 05402-000

Actively Recruiting

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Research Team

J

Joao Carlos Rodrigues, MD, PhD

M

Marcelo Rosa Rezende, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Relationship Between Morphological Change of Median Nerve and Clinical Outcome Before and After Open Carpal Tunnel Release: Ultrasonographic 1-Year Follow-up After Operation.

Tsuyoshi Tajika, Takuro Kuboi, Fumitaka Endo...

https://pubmed.ncbi.nlm.nih.gov/32643958

Quality analysis of prior systematic reviews of carpal tunnel syndrome: an overview of the literature.

Marcelo Cortês Cavalcante, Vinicius Ynoe de Moraes, Guilherme Ladeira Osés...

https://pubmed.ncbi.nlm.nih.gov/36541951

Changes in Clinical Symptoms, Functions, and the Median Nerve Cross-Sectional Area at the Carpal Tunnel Inlet after Open Carpal Tunnel Release.

Jae Kwang Kim, Young-Do Koh, Jong Oh Kim...

https://pubmed.ncbi.nlm.nih.gov/27583113