Evaluation by Clinical and Hand Ultrasound in Carpal Tunnel Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Open Carpal Tunnel Release
Procedure/SurgeryAll 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.
Treatment groups
106 Participants
are divided into 1 treatment groupGroup A: Surgical Cohort1 intervention
Trial outcomes
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.
Time frame
Baseline (preoperative) and at 3 and 6 months post-surgerySecondary outcomes
1
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.
Time frame
Baseline (preoperative) and at 3 and 6 months post-surgery2
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).
Time frame
Baseline (preoperative) and at 3 and 6 months post-surgery3
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.
Time frame
Baseline (preoperative) and at 3 and 6 months post-surgery4
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).
Time frame
Baseline (preoperative) and at 3 and 6 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov