• Sao Paulo Med J · Jan 2023

    Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review.

    • Rafael Luz Sousa, Vinicius Ynoe de Moraes, Alexandre Figueiredo Zobiole, Luis Renato Nakachima, and João Carlos Belloti.
    • MD. Hand Surgeon and Master's Student, Discipline of Hand and Upper Limb Surgery, Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil.
    • Sao Paulo Med J. 2023 Jan 1; 141 (6): e2022086e2022086.

    BackgroundThe diagnostic criteria for carpal tunnel syndrome (CTS) lack uniformity. Moreover, because CTS is a syndrome, there is no consensus as to which signs, symptoms, clinical and complementary tests are more reproducible and accurate for use in clinical research. This heterogeneity is reflected in clinical practice. Thus, establishing effective and comparable care protocols is difficult.ObjectiveTo identify the diagnostic criteria and outcome measures used in randomized clinical trials (RCTs) on CTS.Desing And SettingSystematic review of randomized clinical trials carried out at the Federal University of São Paulo, São Paulo, Brazil.MethodsWe searched the Cochrane Library, PubMed, and Embase databases for RCTs with surgical intervention for CTS published between 2006 and 2019. Two investigators independently extracted relevant data on diagnosis and outcomes used in these studies.ResultsWe identified 582 studies and 35 were systematically reviewed. The symptoms, paresthesia in the median nerve territory, nocturnal paresthesia, and special tests were the most widely used clinical diagnostic criteria. The most frequently assessed outcomes were symptoms of paresthesia in the median nerve territory and nocturnal paresthesia.ConclusionThe diagnostic criteria and outcome measures used in RCTs about CTS are heterogeneous, rendering comparison of studies difficult. Most studies use unstructured clinical criteria associated with ENMG for diagnosis. The Boston Questionnaire is the most frequently used main instrument to measure outcomes.RegistrationPROSPERO (CRD42020150965- https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965).

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