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

NCT05556278 | Unknown

• 1 other identifier: RHB-02/2019
• Study Type: observational
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; nerve conduction study; ultrasound; screening; diagnosis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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; Diagnostic Test: Neurophysiological test

Interventions

Ultrasound study DIAGNOSTIC_TEST

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

Intervention

Neurophysiological test DIAGNOSTIC_TEST

ultrasound protocol described by Chen et al. (2)

Also known as: Nerve conduction study

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).
• Age: 18 to 75 years.
• Consent to participate in the study.

You may not qualify if:

• Previous surgery on the wrist
• Acquired or hereditary pathology causing peripheral neuropathies
• Polyneuropathy of any etiology
• Rheumatoid arthritis
• Diabetes Mellitus

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Hospital Universitario Virgen de la Macarena

Seville, 41009, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 12115985 BACKGROUND

• 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.

  PMID: 27629754 BACKGROUND

• 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.

  PMID: 37948425 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Disease

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 27, 2022
• Study Start: July 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: May 31, 2023
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

ES (1)