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

NCT ID: NCT05556278

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

438 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-05-31

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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Intervention

An electroneurography and an ultrasound study will be performed to patients with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria.

Ultrasound study

Intervention Type DIAGNOSTIC_TEST

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

Neurophysiological test

Intervention Type DIAGNOSTIC_TEST

ultrasound protocol described by Chen et al. (2)

Interventions

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Ultrasound study

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

Intervention Type DIAGNOSTIC_TEST

Neurophysiological test

ultrasound protocol described by Chen et al. (2)

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Nerve conduction study

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen Macarena

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Virgen de la Macarena

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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María de la Paz Murciano Casas, MD

Role: primary

+34 955 00 80 00

Manuel Rodríguez-Piñero Durán, MD

Role: backup

+34 955 00 80 00

References

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American Association of Electrodiagnostic Medicine, American Academy of Neurology, and American Academy of Physical Medicine and Rehabilitation. Practice parameter for electrodiagnostic studies in carpal tunnel syndrome: summary statement. Muscle Nerve. 2002 Jun;25(6):918-22. doi: 10.1002/mus.10185. No abstract available.

Reference Type BACKGROUND
PMID: 12115985 (View on PubMed)

Chen YT, Williams L, Zak MJ, Fredericson M. Review of Ultrasonography in the Diagnosis of Carpal Tunnel Syndrome and a Proposed Scanning Protocol. J Ultrasound Med. 2016 Nov;35(11):2311-2324. doi: 10.7863/ultra.15.12014. Epub 2016 Sep 14.

Reference Type BACKGROUND
PMID: 27629754 (View on PubMed)

Murciano Casas MP, Rodriguez-Pinero M, Jimenez Sarmiento AS, Alvarez Lopez M, Jimenez Jurado G. Evaluation of ultrasound as diagnostic tool in patients with clinical features suggestive of carpal tunnel syndrome in comparison to nerve conduction studies: Study protocol for a diagnostic testing study. PLoS One. 2023 Nov 10;18(11):e0281221. doi: 10.1371/journal.pone.0281221. eCollection 2023.

Reference Type DERIVED
PMID: 37948425 (View on PubMed)

Other Identifiers

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RHB-02/2019

Identifier Type: -

Identifier Source: org_study_id

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