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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05556278
Enrollment
438
Registered
2022-09-27
Start date
2020-07-01
Completion date
2023-05-31
Last updated
2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome, nerve conduction study, ultrasound, screening, diagnosis

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTUltrasound study

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

DIAGNOSTIC_TESTNeurophysiological test

ultrasound protocol described by Chen et al. (2)

Sponsors

Hospital Universitario Virgen Macarena
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Demographic variablesJanuary 2021 to September 2022Sex, 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).
Electrodiagnostic variablesJanuary 2021 to September 2022Motor 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.
Ultrasound variablesJanuary 2021 to September 2022The cross-sectional area (CSA), range of median nerve thinning, wrist-forearm index, flexor retinaculum bulge, power Doppler uptake, and existence of notches
Boston Carpal Tunnel QuestionnaireJanuary 2021 to September 2022
Cost evaluationFrom September 2022 to May 2023Costs of the consumables established by the Andalusian Health Service used in both tests and the average time for each of the tests

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026