Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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Outcome Measures
Primary Outcome Measures
- 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
- Boston Carpal Tunnel Questionnaire [January 2021 to September 2022]
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- Presenting clinical symptoms suggestive of CTS, at least one of the following:
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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.
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Nocturnal symptoms.
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Hypotrophy or atrophy of the thenar eminence.
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Self-described sensory alteration (sensation of cramping, numbness, tingling, hypoalgesia or analgesia).
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Age: 18 to 75 years.
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Consent to participate in the study.
Exclusion Criteria:
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Previous surgery on the wrist
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Acquired or hereditary pathology causing peripheral neuropathies
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Polyneuropathy of any etiology
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Rheumatoid arthritis
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Diabetes Mellitus
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital Universitario Virgen de la Macarena | Sevilla | Spain | 41009 |
Sponsors and Collaborators
- Hospital Universitario Virgen Macarena
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- RHB-02/2019