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

Recruiting

• Conditions: Carpal Tunnel Syndrome
• Interventions: Diagnostic Test: Ultrasound study; Diagnostic Test: Neurophysiological test

• Registration Number: NCT05556278
• Lead Sponsor: Hospital Universitario Virgen Macarena

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.

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Last Update Submitted: 2022-09-23
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27
• Primary Completion: 2022-10-30
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 438

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	Ultrasound study	An electroneurography and an ultrasound study will be performed to patients with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria.
Intervention	Neurophysiological test	An electroneurography and an ultrasound study will be performed to patients with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria.

Primary Outcome Measures

Name	Time	Method
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).
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.
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
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
Boston Carpal Tunnel Questionnaire	January 2021 to September 2022

Trial Locations

Locations (1)

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Spain