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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01972165
First received: October 18, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Idiopathic Carpal Tunnel Syndrome
Procedure: Mini-incision carpal tunnel release
Procedure: Endoscopic carpal tunnel release

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Change of the Boston Carpal Tunnel Questionnaire (BCTQ) [ Time Frame: preoperatively and 24 weeks post-operation ] [ Designated as safety issue: No ]
    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:
  • Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: preoperatively and 24 weeks post-operation ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Change of Ultrasonographic median nerve morphology [ Time Frame: preoperatively and 24 weeks post-operation ] [ Designated as safety issue: No ]
    For ultrasonography Examination, each patient underwent an ultrasound (US) examination by a radiologist pre-operatively and 24 weeks post-operation using a scanner with a 12/5-MHz linear array transducer (GE Healthcare LOGIQ S6, Milwaukee, WI). During the examination, the patient sat in a comfortable position facing the examiner. The measured forearm rested on the table with the palm supine and the fingers semi-extended in the neutral position 20. The transducer was placed directly on the patient's skin with gel. The median nerve was first imaged in a longitudinal scan with the US transducer placed at the midline between the radius and ulna and the center of the transducer placed at the distal wrist crease to obtain an initial general overview of the median nerve. This overview of the median nerve was then used to help the examiner obtain optimal axial images.


Enrollment: 67
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I
Mini-incision carpal tunnel release group
Procedure: Mini-incision carpal tunnel release
Active Comparator: Group II
Endoscopic carpal tunnel release group
Procedure: Endoscopic carpal tunnel release

  Eligibility

Ages Eligible for Study:   27 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01972165

Locations
Korea, Republic of
Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01972165     History of Changes
Other Study ID Numbers: 1-2011-0072
Study First Received: October 18, 2013
Last Updated: October 23, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Carpal tunnel syndrome

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on October 16, 2014