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

NCT02553811 | Completed DMC

• 1 other identifier: 244468
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Compression Neuropathy, Carpal Tunnel; Median Neuropathy, Carpal Tunnel

Keywords

carpal tunnel syndrome; clinical examination; diagnosis; clinical trial; median nerve compression; accuracy; ultrasonography; electromyography; electrodiagnostic testing

Outcome Measures

Primary Outcomes (3)

• Accuracy of the ultrasonography (US)

  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).

  four months

• Accuracy of the electromyograph (EMG)

  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).

  fours months

• Life quality

  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).

  fours months

Secondary Outcomes (1)

• Improvement in severity of symptoms and functional status of the patients

  four months

Study Arms (1)

intervention

EXPERIMENTAL

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

Diagnostic Test: accuracy diagnostic

Interventions

accuracy diagnostic DIAGNOSTIC_TEST

effectiveness of the ultrasonography and electromiography for best performance and diagnostic accuracy in carpal tunnel syndrome

Also known as: accuracy of the ultrasonography, accuracy of the electromiography

intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Hospital Regional do Vale do Paraiba

Taubaté, São Paulo, 12030-180, Brazil

Location

Related Publications (2)

• 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.

  RESULT

• Pimentel BFR, Faloppa F, Tamaoki MJS, Belloti JC. Effectiveness of ultrasonography and nerve conduction studies in the diagnosing of carpal tunnel syndrome: clinical trial on accuracy. BMC Musculoskelet Disord. 2018 Apr 12;19(1):115. doi: 10.1186/s12891-018-2036-4.

  PMID: 29649998 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Disease

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• João C Belloti, researcher

  Federal University Of the São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 18, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

BR (1)