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

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ClinicalTrials.gov Identifier: NCT02553811
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Benedito Felipe Rabay Pimentel, Federal University of São Paulo

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 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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Compression Neuropathy, Carpal Tunnel Median Neuropathy, Carpal Tunnel Diagnostic Test: accuracy diagnostic Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Ultrasonography and Electromyography in the Diagnosis of Carpal Tunnel Syndrome
Actual Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: intervention
accuracy diagnostic in carpal tunnel syndrome = evaluation and comparison ultrasonography X electromyography
Diagnostic Test: accuracy diagnostic
effectiveness of the ultrasonography and electromiography for best performance and diagnostic accuracy in carpal tunnel syndrome
Other Names:
  • accuracy of the ultrasonography
  • accuracy of the electromiography




Primary Outcome Measures :
  1. Accuracy of the ultrasonography (US) [ Time Frame: 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).

  2. Accuracy of the electromyograph (EMG) [ Time Frame: 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).

  3. Life quality [ Time Frame: 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).


Secondary Outcome Measures :
  1. Improvement in severity of symptoms and functional status of the patients [ Time Frame: four 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).



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553811


Locations
Brazil
Hospital Regional do Vale do Paraiba
Taubate, São Paulo, Brazil, 12030-180
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: João C Belloti, researcher Federal University Of the São Paulo

Publications of Results:
Pimentel B F, Abicalaf C A, Braga L, Albertoni W M, Fernandes C H, Sernik R A, Faloppa F. Cros-sectional area of the median nerve characterized by ultrasound in patients with carpal tunnel syndrome before and after release of the transverse carpal ligament. Journal of Diagnostic Medical Sonography 2013; 29(3):116-121. Graham B, Regehr G, Naglie G, Wright J G. Development and validation of diagnostic criteria for carpal tunnel syndrome. J Hand Surg 2006; 31A: 919-924 D'Arcy C A, McGee S. The rational clinical examination. Does this patient have carpal tunnel syndrome ? JAMA 2000; 283(23): 3110-3117. McCabe S. Evidence-Based Medicine - Diagnosis of Carpal Tunnel Syndrome. J Hand Surg 2010; 35A: 646-648. Sernik R A, Abicalaf C A, Pimentel B F, Braga-Baiak A, Braga L, Cerri G G. Ultrasound features of carpal tunnel syndrome: a prospective case-control study. Skelectal Radiol 2008; 37: 49-53.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benedito Felipe Rabay Pimentel, master, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02553811     History of Changes
Other Study ID Numbers: 244468
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Benedito Felipe Rabay Pimentel, Federal University of São Paulo:
carpal tunnel syndrome
clinical examination
diagnosis
clinical trial
median nerve compression
accuracy
ultrasonography
electromyography
electrodiagnostic testing

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Median Neuropathy
Disease
Pathologic Processes
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn