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

Sponsor
Hospital Universitario Virgen Macarena (Other)
Overall Status
Recruiting
CT.gov ID
NCT05556278
Collaborator
(none)
438
1
35
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound study
  • Diagnostic Test: Neurophysiological test

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
438 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Intervention

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

Diagnostic Test: Neurophysiological test
ultrasound protocol described by Chen et al. (2)
Other Names:
  • Nerve conduction study
  • Outcome Measures

    Primary Outcome Measures

    1. Demographic variables [January 2021 to September 2022]

      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).

    2. Electrodiagnostic variables [January 2021 to September 2022]

      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.

    3. Ultrasound variables [January 2021 to September 2022]

      The cross-sectional area (CSA), range of median nerve thinning, wrist-forearm index, flexor retinaculum bulge, power Doppler uptake, and existence of notches

    4. Boston Carpal Tunnel Questionnaire [January 2021 to September 2022]

    5. Cost evaluation [From September 2022 to May 2023]

      Costs of the consumables established by the Andalusian Health Service used in both tests and the average time for each of the tests

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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).

    1. Age: 18 to 75 years.

    2. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario Virgen de la Macarena Sevilla Spain 41009

    Sponsors and Collaborators

    • Hospital Universitario Virgen Macarena

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hospital Universitario Virgen Macarena
    ClinicalTrials.gov Identifier:
    NCT05556278
    Other Study ID Numbers:
    • RHB-02/2019
    First Posted:
    Sep 27, 2022
    Last Update Posted:
    Sep 27, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hospital Universitario Virgen Macarena
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2022