Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction

Study Overview
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Brief Summary
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The main objective is to investigate the value of ultrasound in the diagnosis of Carpal Tunnel Syndrome (CTS), and among the secondary objectives, to establish the ultrasound parameters that are predictors of CTS in comparison with neurophysiological studies, attempting to standardize a protocol and reference values that determine the presence or absence of CTS. Finally, cost-effectiveness analysis is proposed.

Detailed Description
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The reference test with which the ultrasound is compared is the neurophysiological test (NPT). The expected timeline for the study is to be performed between July 2020 and May 2023.

Official Title
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Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Diagnostic Test: Ultrasound study
* Diagnostic Test: Neurophysiological test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting clinical symptoms suggestive of CTS, at least one of the following: Neuropathic profile pain in wrist-hand at the level of the median nerve territory (wrist, first-second-third, and radial half of the fourth finger by palmar and/or volar side), possibility of irradiation of the pain towards the forearm and/or arm. Nocturnal symptoms. Hypotrophy or atrophy of the thenar eminence. Self-described sensory alteration (sensation of cramping, numbness, tingling, hypoalgesia or analgesia). Age: 18 to 75 years. Consent to participate in the study. Exclusion Criteria: Previous surgery on the wrist Acquired or hereditary pathology causing peripheral neuropathies Polyneuropathy of any etiology Rheumatoid arthritis Diabetes Mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>An electroneurography and an ultrasound study will be performed to patients with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria. | Diagnostic Test: Ultrasound study<br>* based on the recommendations of the American Association of Electrodiagnostic Medicine (AAEM) (1)<br>Diagnostic Test: Neurophysiological test<br>* ultrasound protocol described by Chen et al. (2)<br>* Other names: Nerve conduction study;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic variables | Sex, age, time of evolution of the clinic, manual dominance, hand affected, body mass index, employment status, type of work (pink, white or blue collar), time worked, triggers of symptoms, what symptoms are relieved with, as well as toxic habits, whether they are smokers (to be answered affirmative or negative) or alcohol consumers (to be answered affirmative or negative). | January 2021 to September 2022 | 
| Electrodiagnostic variables | Motor conduction velocity of the median nerve (calculating distal motor latency and wrist-elbow motor conduction velocity), motor conduction velocity of the ulnar nerve (calculating distal motor latency, lower and upper wrist-elbow motor conduction velocity), orthodromic sensory conduction of the median, ulnar and radial nerve, as well as antidromic sensory conduction of the median, ulnar and radial nerve. | January 2021 to September 2022 | 
| Ultrasound variables | The cross-sectional area (CSA), range of median nerve thinning, wrist-forearm index, flexor retinaculum bulge, power Doppler uptake, and existence of notches | January 2021 to September 2022 | 
| Boston Carpal Tunnel Questionnaire |  | January 2021 to September 2022 | 
| Cost evaluation | Costs of the consumables established by the Andalusian Health Service used in both tests and the average time for each of the tests | From September 2022 to May 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carpal tunnel syndrome, nerve conduction study, ultrasound, screening, diagnosis