跳至主要内容
临床试验/NCT02553811
NCT02553811已完成不适用

Accuracy of Ultrasonography and Electromyography in the Diagnosis of Carpal Tunnel Syndrome

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
115
试验地点
2
主要终点
Life quality

研究概览

简要总结

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 evaluated and compared the diagnostic accuracy of the ultrasonography (US) and electromyography (EMG), considering the postoperative status of remission of paresthesia as the reference standard in the diagnosis of CTS.

详细描述

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 reference standard universally accepted for the diagnosis of CTS contributes to this scenario.

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 reference standard. 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 reference 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, innovative in its method has as primary objective to compare the accuracy of ultrasonography in relation electromyography in the diagnosis of carpal tunnel syndrome, using to the results of the surgical treatment as the reference standard.

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).

Patients with clinical suspicion of CTS, who were referred and attended consecutively in our specialty clinic in hand surgery, were submitted to an initial clinical evaluation (ACI), by a same specialist in hand surgery, who used the CTS-6 clinical diagnostic instrument of GRAHAM et al. (2006), represented by a logistic regression model that estimates the diagnostic probability of CTS based on the presence or absence of the 6 diagnostic criteria that are: paresthesia, night paresthesia, weakness and/or atrophy thenar musculature, Tinel signal, Phalen test and loss of 2-points discrimination.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with a CTS-6 clinical diagnostic instrument of GRAHAM et al. (2006) with score equal to or greater than 12 points
  • Female gender
  • Aged 40 to 80 years
  • Patients with unilateral or bilateral involvement (only one hand was considered for inclusion)
  • Patients who agreed to participate in this study and who signed the informed consent form (TCLE)
  • Patients who underwent some kind of previous conservative treatment for CTS without clinical improvement.

排除标准

  • Cervical radiculopathy
  • Thoracic outlet syndrome
  • Pronator syndrome
  • Patients with history of previous surgical release of the carpal tunnel
  • Patients with sequelae of fracture of the wrist
  • Patients who did not agree to participate or who did not sign the TCLE.

研究组 & 干预措施

intervention

Experimental

accuracy diagnostic in carpal tunnel syndrome = evaluation and comparison ultrasonography X electromyography

干预措施: accuracy diagnostic (Diagnostic Test)

结局指标

主要结局

Life quality

时间窗: fours months

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a disease-specific STC questionnaire, self-administered, translated and validated for the Portuguese language, which evaluates two components: a symptom severity scale with 11 questions and a functional status scale with 8 issues. All patients in this study responded to two BCQT, the first after initial clinical evaluation and the second at the end of the fourth month of postoperative follow-up. To assess the improvement of severity and functional status of the patients in this study, a medically significant improvement in the two scales was expected between the means of the second Boston questionnaire (according to BCQT) compared to the means of the first Boston questionnaire (first BCQT).

Accuracy of the electromyograph (EMG)

时间窗: fours months

Patients with CTS who obtained as a result of surgical treatment, remission of paresthesia were considered to be truly ill, and patients who did not receive remission of paresthesia were considered non-diseased. The remission of paresthesia evaluated after surgical treatment was considered the reference standard for the diagnosis of CTS. The accuracy of EMG was assessed by evaluating the results of the EMG (positive or negative) in relation to the results of surgery (remission of paresthesia or non-remission of paresthesia).

Accuracy of the ultrasonography (US)

时间窗: four months

Patients with CTS who obtained as a result of surgical treatment, remission of paresthesia were considered to be truly ill, and patients who did not receive remission of paresthesia were considered non-diseased. The remission of paresthesia evaluated after surgical treatment was considered the reference standard for the diagnosis of CTS. The accuracy of US was assessed by evaluating the results of the US (positive or negative) in relation to the results of surgery (remission of paresthesia or non-remission of paresthesia).

次要结局

  • Improvement in severity of symptoms and functional status of the patients(four months)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benedito Felipe Rabay Pimentel

master

Federal University of São Paulo

研究点 (2)

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