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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | An electroneurography and an ultrasound study will be performed to patients with clinical suspicion of CTS and fulfilling the inclusion/exclusion criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound study | Diagnostic Test | based on the recommendations of the American Association of Electrodiagnostic Medicine (AAEM) (1) |
|
| 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 |
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Inclusion Criteria:
Presenting clinical symptoms suggestive of CTS, at least one of the following:
Age: 18 to 75 years.
Consent to participate in the study.
Exclusion Criteria:
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Patients with clinical suspicion of CTS that come consecutively from the Neurophysiology Department of the Virgen Macarena Hospital in Seville (Spain).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Macarena | Recruiting | Seville | 41009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12115985 | Background | 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. | |
| 27629754 |
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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.
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D004194 | Disease |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000092184 | Nerve Conduction Studies |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| Neurophysiological test | Diagnostic Test | ultrasound protocol described by Chen et al. (2) |
|
|
| 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. |
| 37948425 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |