Idiopathic Carpal Tunnel Syndrome Clinical Trial
| Verified date | October 2013 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 67 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 27 Years to 82 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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. | preoperatively and 24 weeks post-operation | No |
| Primary | 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. | preoperatively and 24 weeks post-operation | No |
| Secondary | 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. | preoperatively and 24 weeks post-operation | No |