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
1 other identifier
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 18, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedOctober 30, 2013
October 1, 2013
1.7 years
October 18, 2013
October 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
preoperatively and 24 weeks post-operation
Other Outcomes (1)
Change of Ultrasonographic median nerve morphology
preoperatively and 24 weeks post-operation
Study Arms (2)
Group I
EXPERIMENTALMini-incision carpal tunnel release group
Group II
ACTIVE COMPARATOREndoscopic carpal tunnel release group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 28158978DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2013
First Posted
October 30, 2013
Study Start
November 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 30, 2013
Record last verified: 2013-10