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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556278
• Other study ID #: RHB-02/2019
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2022
• Source: Hospital Universitario Virgen Macarena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 438
• Est. completion date: May 31, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Ultrasound study
based on the recommendations of the American Association of Electrodiagnostic Medicine (AAEM) (1)
• Neurophysiological test
ultrasound protocol described by Chen et al. (2)

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

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. Epub 2016 Sep 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic variables	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).	January 2021 to September 2022
Primary	Electrodiagnostic variables	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.	January 2021 to September 2022
Primary	Ultrasound variables	The cross-sectional area (CSA), range of median nerve thinning, wrist-forearm index, flexor retinaculum bulge, power Doppler uptake, and existence of notches	January 2021 to September 2022
Primary	Boston Carpal Tunnel Questionnaire		January 2021 to September 2022
Primary	Cost evaluation	Costs of the consumables established by the Andalusian Health Service used in both tests and the average time for each of the tests	From September 2022 to May 2023