Overview

This trial is active, not recruiting.

Conditions carpal tunnel syndrome, compression neuropathy, carpal tunnel, median neuropathy, carpal tunnel
Treatment accuracy diagnostic
Sponsor Federal University of São Paulo
Start date April 2013
End date October 2015
Trial size 145 participants
Trial identifier NCT02553811, 244468

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Primary purpose diagnostic
Arm
(Experimental)
accuracy diagnostic in carpal tunnel syndrome = evaluation and comparison clinical examination X ultrasound X electromyography
accuracy diagnostic effectiveness of clinical examination
effectiveness of clinical examination, ultrasound and electromiography for best performance and diagnostic accuracy in carpal tunnel syndrome

Primary Outcomes

Measure
Effectiveness of clinical examination (CE) in the diagnosis of carpal tunnel syndrome (CTS)
time frame: four months
Effectiveness of ultrasound (US) in the diagnosis of carpal tunnel syndrome (CTS)
time frame: four months
Effectiveness of electromyography (EMG) in the diagnosis of carpal tunnel syndrome (CTS)
time frame: four months

Secondary Outcomes

Measure
Assessment of quality of life by Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) in carpal tunnel syndrome (CTS)
time frame: four months

Eligibility Criteria

Female participants from 40 years up to 80 years old.

Inclusion criteria: - one affected hand (even if involvement is unilateral or bilateral). - have agreed and signed the Informed Consent (IC) - which has made some sort of conservative treatment for CTS (oral anti-inflammatory and systemic, physical therapy, immobilization and infiltration) with no improvement for patients of the study group and with improvement for patients of the control group. - presence of at least 4 of the 6 criteria for clinical diagnostic tool Graham et al for CTS(CTS-6) for patients of the study group and presence of at least 1 of the 6 criteria for clinical diagnostic tool Graham et al for CTS(CTS-6) for patients of the control group. Exclusion criteria: - No concordance and not signature of the Consent term and Informed (IC) - diseases of the cervical spine (radiculopathy, osteoarthritis). - sequelae of previous surgery on wrist and hand. - other compression syndromes of upper limb and shoulder girdle.

Additional Information

Official title Effectiveness of Clinical Examination, Ultrasound and Electromyography in the Diagnosis of Carpal Tunnel Syndrome: Study Protocol for a Clinical Trial of Accuracy
Principal investigator João C Belloti, researcher
Description 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 other benchmarks, such as the degree of clinical improvement after surgical treatment of CTS or a combination of clinical signs and symptoms. The value of diagnostic tests for CTS can be established by comparing the diagnostic strategies and studying how they can affect the likelihood of STC. This spectrum can be considered the results of surgical treatment as the golden standard, as these are directly related to the diagnosis of CTS. Surgical treatment by classical open surgery is the definitive treatment of CTS and provides relief from symptoms, mainly the remission of paresthesia, with satisfactory results in up to 98% of the cases. The discomfort caused by paresthesia in the quality of life of patients and impairs daily manual activities and the quality of sleep is considerable in CTS. The remission of paresthesia is a clinical improvement parameter of the disease being an expected and relevant outcome for the patient. Primary and well-designed controlled studies with good methodological quality to guide the diagnostic practices and evaluate their effectiveness in an integrated manner in carpal tunnel syndrome (CTS) are unusual and challenging in the current literature. This study protocol, innovative in its method has as primary objective to determine the effectiveness of the clinical examination (CE), the ultrasound (US) and electromyograph (EMG) for evaluating and comparing the best performance and diagnostic accuracy. The study design is a clinical trial of accuracy, primary, longitudinal, controlled, prospective, and performed in a single center. This clinical trial follows the accuracy STARD recommendations (Standards for Reporting of Diagnostic Accuracy). The diagnostic interventions such as initial clinical evaluation will be performed by an experienced hand surgeon and consist of medical history with the application and avaliation of 6 clinical diagnostic criteria for CTS according to Graham et al (CTS 6) that are: paresthesia, night paresthesia, weakness and/or atrophy thenar musculature, Tinel signal, Phalen test and loss of 2-points discrimination. The ultrasonography (US) of the wrist for patients in the study group and the control group will be considered for evaluation of diagnostic accuracy, US examinations of the wrist conducted randomly by experienced and reputable origin for any reason during the period of 6 months prior to initial clinical evaluation. If not performe US, a futher examination will be required after the initial clinical evaluation. For the diagnosis of CTS will be considered as the cutoff point value greater than or equal to 10.0 mm² diameter of the median nerve (direct method) in the proximal anatomical limit of the carpal tunnel at the wrist as having STC. The electromyography (EMG) of the upper limbs for patients in the study group and the control group will be considered for evaluation of diagnostic accuracy, EMG examination of the upper limbs conducted randomly by experienced and reputable origin for any reason within six months preceding the initial clinical evaluation. If not performed EMG, a further examination will be required after the initial clinical evaluation. For the diagnosis of CTS will be considered as the cutoff point to measure the sensory conduction velocity (second finger-wrist segment) equal to or less than 50 m / s as having STC. After the examinations of US and EMG, only patients in the study group shall be submitted to surgical treatment for CTS. The surgery will be of an ambulatory character, with Bier local intravenous anesthetic technique, with the use of xylocaine 1% without vasoconstrictor and intravenous sedation. The surgical technique is surgical decompression via classical open surgery for carpal tunnel. All patients will receive medical discharge on the same day as the day of surgery. During the medical discharge process, the patient and his companion are given information about the surgery, postoperative care and day and time of the outpatient visit for dressing. The first dressing is performed after one week of the date of surgery and the stitches are removed after 2 weeks. Each patient will be followed on an outpatient basis and monthly to the 4th month after surgery. The statistical methodology and characteristics of the patients will be evaluated descriptively. For categorical variables, relative, absolute frequencies, and numeric variables will be presented as summary measures (mean and standard deviation). To compare the accuracies of the US and EMG the McNemar test will be used. Clinical diagnosis of CTS will be compared with the US and EMG using the chi-square test. Will be calculated the sensitivity, specificity, positive predictive value and negative in two diagnostic groups by calculating paired samples, using as a reference the standard surgical treatment and comparing this with the results of US and EMG. The calculations of positive and negative predictive value showing the probability of the patient having or not CTS when the result is positive (with disease) and negative (no disease) respectively. The accuracy between the clinical diagnosis and the US and between the clinical diagnosis and EMG will be evaluated by Kappa coefficient. To compare the proportion of correct diagnoses between the 2 groups the chi-square test will be used. The effectiveness of clinical examination shall be calculated by comparing the percentage of true positive cases of surgical treatment compared to true positives cases found by clinical examination, US and EMG. The summary measures will be accompanied by their 95% confidence interval. Will be considered p <0.05 as significant. The sample size calculation was carried out considering the difference of at least 20% in the accuracy of diagnostic tests for the clinical diagnosis with statistical power of 84.4% and 5% significance level. To do so, a total of 145 patients with CTS divided into 115 patients for the study group and 30 patients for the control group, will be required. There is a lack of accuracy of properly designed studies with good quality evidence to recommend good diagnostic practices in CTS. This study protocol presents the innovative proposal of conducting a clinical trial of accuracy, specifically designed when there is no golden standard defined for the diagnosis of the CTS, using the reference paresthesia after surgery as a relevant outcome from the standpoint of the patient. The use of more accurate diagnostic criteria with a more effective diagnostic protocol for the clinical examination, the US and the EMG, based on a high level of evidence will lead directly into the paradigm shift for clinical decision-making, effective and safe CTS treatment.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.