Comparison of Subjective Outcomes and Changes of Ultrasonographic Morphology of Median Nerves of Mini-open and Endoscopic Carpal Tunnel Release in Patients With Idiopathic Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Idiopathic Carpal Tunnel Syndrome
• Interventions: Procedure: Mini-incision carpal tunnel release; Procedure: Endoscopic carpal tunnel release

• Registration Number: NCT01972165
• Lead Sponsor: Yonsei University

Brief Summary

A few studies have shown that the mini-incision release technique decreases the pathologic swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic release technique similarly reverses these pathological changes in the median nerve along the carpal tunnel in patients with CTS compared with the mini-incision release.

Investigators therefore conducted the current study to compare the subjective outcomes and US-measured morphological changes in the median nerve in patients with CTS who received either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function scores and the DASH scores, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or endoscopic carpal tunnel release.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-23
• Last Update Submitted: 2013-10-23
• Study First Posted: 2013-10-30
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Patients who are 20 years or older.
• Patients with idiopathic CTS that was confirmed by electrodiagnostic tests
• Patients with idiopathic CTS who were scheduled for carpal tunnel release

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Exclusion Criteria

• Patients with a history of wrist-area fracture or dislocation
• Patients with previous carpal tunnel release
• Patients with associated cervical radiculopathy, cubital tunnel syndrome, thoracic outlet syndrome, diabetes mellitus, hypothyroidism, arthritis, or Burger's disease
• Patients with cognitive impairment that affected the patient's ability to complete the questionnaires
• Patients with worker's compensation issues
• Patients with inadequate follow-up (i.e., less than 24 weeks post-operation)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Mini-incision carpal tunnel release	Mini-incision carpal tunnel release group
Group II	Endoscopic carpal tunnel release	Endoscopic carpal tunnel release group

Primary Outcome Measures

Name	Time	Method
Change of the Boston Carpal Tunnel Questionnaire (BCTQ)	preoperatively and 24 weeks post-operation	The BCTQ is a disease-specific status scale that incorporates both a symptom severity scale and a functional scale. The symptom severity scale (BCTQ-S) is comprised of eleven items that address the severity, frequency, and duration of symptoms, whereas the functional status scale (BCTQ-F) is comprised of eight questions that assess the difficulty of performing eight daily tasks. Each question offers five possible responses of increasing severity, which are scored from 1 (none) to 5 (most severe); the mean values of all the items in the BCTQ were calculated.

Secondary Outcome Measures

Name	Time	Method
Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	preoperatively and 24 weeks post-operation	The DASH quantifies general disabilities related to the upper extremity. The questionnaire contains 30 items: 21 questions that assess difficulties with specific tasks, five that evaluate symptoms, and four that evaluate social function, work function, sleep, and confidence. The DASH scores are scaled between 0 and 100 with higher scores representing greater upper extremity disability.

Trial Locations

Locations (1)

Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of