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

Andalusian Health Service

Status: Enrolling

Conditions: Carpal Tunnel Syndrome

Treatments: Diagnostic Test: Ultrasound study; Diagnostic Test: Neurophysiological test

Study type: Observational

Funder types: Other

Identifiers

NCT05556278

RHB-02/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 438 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

438 participants in 1 patient group

Intervention

Description:

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

Treatment:

Diagnostic Test: Ultrasound study

Diagnostic Test: Neurophysiological test