Clinical trial NCT01972165: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Carpal Tunnel Syndrome
Keywords: Carpal tunnel syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 67
Sex: ALL
Minimum age (years): 27
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
timeFrame: preoperatively and 24 weeks post-operation
Secondary outcomes:
measure: Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: preoperatively and 24 weeks post-operation
Other outcomes:
measure: Change of Ultrasonographic median nerve morphology
timeFrame: preoperatively and 24 weeks post-operation
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System
Study officials:
References:
citation: Oh WT, Kang HJ, Koh IH, Jang JY, Choi YR. Morphologic change of nerve and symptom relief are similar after mini-incision and endoscopic carpal tunnel release: a randomized trial. BMC Musculoskelet Disord. 2017 Feb 3;18(1):65. doi: 10.1186/s12891-017-1438-z.