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
Primary Purpose
Idiopathic Carpal Tunnel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mini-incision carpal tunnel release
Endoscopic carpal tunnel release
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome
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)
Sites / Locations
- Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group I
Group II
Arm Description
Mini-incision carpal tunnel release group
Endoscopic carpal tunnel release group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01972165
Brief Title
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
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Carpal Tunnel Syndrome
Keywords
Carpal tunnel syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Mini-incision carpal tunnel release group
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Endoscopic carpal tunnel release group
Intervention Type
Procedure
Intervention Name(s)
Mini-incision carpal tunnel release
Intervention Type
Procedure
Intervention Name(s)
Endoscopic carpal tunnel release
Primary Outcome Measure Information:
Title
Change of the Boston Carpal Tunnel Questionnaire (BCTQ)
Description
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
Secondary Outcome Measure Information:
Title
Change of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Description
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
Other Pre-specified Outcome Measures:
Title
Change of Ultrasonographic median nerve morphology
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Department of Orthopedic Surgery,Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28158978
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.
Results Reference
derived
Learn more about this trial
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
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