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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 438

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Recruiting
    • Hospital Universitario Virgen de la Macarena
    • Contact: María de la Paz Murciano Casas, MD; Phone Number: +34 955 00 80 00; Email: maripazmurciano@gmail.com
    • Contact: Manuel Rodríguez-Piñero Durán, MD; Phone Number: +34 955 00 80 00; Email: manuel.rodriguezpinero.sspa@juntadeandalucia.es
    • Sub-Investigator: Aguas Santas Jiménez Sarmiento
    • Sub-Investigator: Mercedes Álvarez López
    • Sub-Investigator: Gema Jiménez Jurado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical suspicion of CTS that come consecutively from the Neurophysiology Department of the Virgen Macarena Hospital in Seville (Spain).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Boston Carpal Tunnel Questionnaire		January 2021 to September 2022
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

Collaborators and Investigators

• Sponsor: Hospital Universitario Virgen Macarena

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): October 30, 2022
• Study Completion (ANTICIPATED): May 31, 2023

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (ACTUAL): September 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; ultrasound; diagnosis; screening; nerve conduction study
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: RHB-02/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The full study protocol can be accessed by contacting the trial team at (e-mail). Anonymized participants level data and statistical codes used for the analysis are available on request and subject to data sharing agreements. Data sharing may only be possible after relevant embedded trials have been published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No