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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01972165
Enrollment
67
Registered
2013-10-30
Start date
2011-11-30
Completion date
2013-07-31
Last updated
2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndrome

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.

Interventions

PROCEDUREMini-incision carpal tunnel release

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
27 Years to 82 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change of the Boston Carpal Tunnel Questionnaire (BCTQ)preoperatively and 24 weeks post-operationThe 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

MeasureTime frameDescription
Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnairepreoperatively and 24 weeks post-operationThe 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

MeasureTime frameDescription
Change of Ultrasonographic median nerve morphologypreoperatively and 24 weeks post-operationFor 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026