An interventional study of Mini-incision carpal tunnel release and Endoscopic carpal tunnel release in Idiopathic Carpal Tunnel Syndrome, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 27 Years to 82 Years. Per ClinicalTrials.gov, last updated 2013-10-30.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 140 are open to participants now.
This study's enrollment of 67 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mini-incision carpal tunnel release group
Procedure: Mini-incision carpal tunnel release
Endoscopic carpal tunnel release group
Procedure: Endoscopic carpal tunnel release
Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
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.
Time frame: preoperatively and 24 weeks post-operation
Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
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.
Time frame: preoperatively and 24 weeks post-operation
Change of Ultrasonographic median nerve morphology
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.
Time frame: preoperatively and 24 weeks post-operation
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yonsei University