Clinical Trial: Diagnosis of Carpal Tunnel Syndrome: Effectiveness of Diagnostic Tests. Clinical Trial of Accuracy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Effectiveness of Clinical Examination, Ultrasound and Electromyography in the Diagnosis of Carpal Tunnel Syndrome: Study Protocol for a Clinical Trial of Accuracy

Brief Summary: There is no golden universal standard for the diagnosis of Carpal Tunnel Syndrome (CTS). In this scenario, for a comparison of the effectiveness of the principal diagnostic tests CTS should determine how they affect the likelihood of disease through a clinical accuracy trial of good methodological quality in order to get answers to what is the best diagnostic strategy in clinical CTS practice. The paresthesia in nerve distribution territory median hands is the most common symptom in patients with CTS. The nuisance caused by paresthesia directly affects the quality of life of patients and impairs daily manual activities and sleep quality. To evaluate the remission of paresthesia is a major clinical criterion for improved STC being an expected relevant outcome for the patient. This study evaluates and compares the diagnostic accuracy of clinical examination (CE), ultrasound (US) and electromyography (EMG), considering the postoperative status of remission of paresthesia as the golden standard in the diagnosis of CTS.

Detailed Summary:

Carpal tunnel syndrome (CTS) is characterized by median nerve compression at the level of the wrist. It represents 90% of compressive neuropathies and is the most common upper member. For being a major cause of disability in hands, the early and accurate diagnosis to obtain a definitive treatment in CTS is essential. Despite this, there is no consensus on which is the most effective diagnostic criteria for CTS. The absence of a golden standard, universally accepted for the diagnosis of CTS contributes to this scenario. The CTS diagnostic practice is controversial because of the inconsistent and large variations in the clinical presentation of signs and symptoms as well as the performance of clinical trials.

The clinical diagnosis is mainly represented by symptoms of numbness in the median nerve distribution territory in the hand and the positivity of provocative tests of Phalen and Tinel and varies considerably in performance and accuracy of the sensitivity values (10-80%) and specificity (55 to 86%). Ultrasonography (US) and electromyography (EMG) are the complementary examinations most often used in the diagnosis of CTS, but overestimated in their performance and require caution in interpreting the results, particularly the lack of a consensus on the ideal cutoff point for considering the diagnosis of CTS. This results in a wide variation in results of sensitivity and specificity for these tests, both the EMG (sensitivity = 82 to 98% and specificity = 19 to 88%) and for the US (sensitivity = 70 to 98% and specificity = 63 to 100%), in addition to a high proportion (20-40%) of false-negative and false-positive.

Most diagnostic accuracy studies at CTS compare the results of the US with EMG, considering most of the time the EMG as a standard of reference. There are few studies comparing the results of the US and EMG using o
Sponsor: Federal University of São Paulo

Current Primary Outcome:

  • Effectiveness of clinical examination (CE) in the diagnosis of carpal tunnel syndrome (CTS) [ Time Frame: four months ]

    To evaluate the effectiveness of the CE in STC will need to evaluate and compare the diagnostic accuracy of CE with the remission of paresthesia as the gold standard for the diagnosis of CTS.

    The accuracy of CE will be given by comparing the pre-operative results of these tests (presence or absence of CTS) in relation to remission or not of paresthesia (gold standart) until the fourth month postoperatively. To determine accuracy, the negative Phalen test and the absence of paresthesia reported by the patient in this period will be considered as "cure" (true positive). The positive Phalen test and not regression paresthesia referred by patients in this period will be considered as non-healing (false positive). For the clinical diagnosis of CTS will be assigned positive / negative or present / absent without unit of measurement.

  • Effectiveness of ultrasound (US) in the diagnosis of carpal tunnel syndrome (CTS) [ Time Frame: four months ]

    To evaluate the effectiveness of the US in STC will need to evaluate and compare the diagnostic accuracy of US with the remission of paresthesia as the gold standard for the diagnosis of CTS.

    The accuracy of US will be given by comparing the pre-operative results of these tests (presence or absence of CTS) in relation to remission or not of paresthesia (gold standart) until the fourth month postoperatively. The US presents a correct result when positive in the presence of CTS (t

    Original Primary Outcome: Same as current

    Current Secondary Outcome: Assessment of quality of life by Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) in carpal tunnel syndrome (CTS) [ Time Frame: four months ]

    Patients in the study group will respond to Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) translated and validated for Portuguese preoperative (after initial clinical evaluation) and postoperative (4th month PO). It is a disease specific questionnaire, self-administered, and evaluates the severity of the symptoms and functional status of patients with CTS. The BCTQ assesses the symptoms and the severity, frequency, time and type. The functional degree of scale evaluates how the syndrome affects daily life. Issues relating to the severity scale are composed of 11 questions. Each question has five answers, placed in order of increasing severity of symptoms. The issues relating to the functional status are composed of 8 questions, each of which corresponds to a functional activity. Each activity has a 5-degree-answer of difficulty progressively worsening.


    Original Secondary Outcome: Same as current

    Information By: Federal University of São Paulo

    Dates:
    Date Received: September 10, 2015
    Date Started: April 2013
    Date Completion: December 2016
    Last Updated: October 20, 2015
    Last Verified: October 2015