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

Hospital Universitario Virgen Macarena438 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

438

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasound studyDIAGNOSTIC_TEST

based on the recommendations of the American Association of Electrodiagnostic Medicine (AAEM) (1)

Neurophysiological testDIAGNOSTIC_TEST

ultrasound protocol described by Chen et al. (2)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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). 2. Age: 18 to 75 years. 3. Consent to participate in the study. Exclusion Criteria: 1. Previous surgery on the wrist 2. Acquired or hereditary pathology causing peripheral neuropathies 3. Polyneuropathy of any etiology 4. Rheumatoid arthritis 5. Diabetes Mellitus

Locations (1)

Hospital Universitario Virgen de la Macarena

Seville, Spain

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 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

Time frame: January 2021 to September 2022

Boston Carpal Tunnel Questionnaire

Time frame: 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

Time frame: From September 2022 to May 2023

Data from ClinicalTrials.gov

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