Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy
Primary Purpose
Carpal Tunnel Syndrome, Entrapment Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
keyhole approach
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring microsurgical treatment, pain, dexterity, Phalen sign, functional status
Eligibility Criteria
Inclusion Criteria:
- Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.
Exclusion Criteria:
- Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
keyhole approach
Arm Description
open minimally invasive approach
Outcomes
Primary Outcome Measures
Levine Severity Scale
pain grades with 5 grades of intensity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03062722
Brief Title
Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy
Official Title
Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 1, 2015 (Actual)
Study Completion Date
July 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ivan Segura Duran
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.
Detailed Description
Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Entrapment Neuropathy
Keywords
microsurgical treatment, pain, dexterity, Phalen sign, functional status
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
keyhole approach
Arm Type
Experimental
Arm Description
open minimally invasive approach
Intervention Type
Procedure
Intervention Name(s)
keyhole approach
Intervention Description
The surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.
Primary Outcome Measure Information:
Title
Levine Severity Scale
Description
pain grades with 5 grades of intensity
Time Frame
2 years follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed diagnosis who had neurologic exam, electromyography, cervical spine X rays showing no structural disturbances and with at least 3 months of persistent pain refractory to medical management and physical therapy.
Exclusion Criteria:
Patients with a history of direct trauma or orthopedic lesions in the carpal region, endocrine and/or metabolic disturbances (hypothyroidism, diabetes) and those that had previous local administration of steroids were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ramos Zuñiga, M.D. PhD
Organizational Affiliation
Universidad se Guadalajara
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28484650
Citation
Ramos-Zuniga R, Garcia-Mercado CJ, Segura-Duran I, Zepeda-Gutierrez LA. Efficacy of Keyhole Approach to Carpal Tunnel Syndrome under Ambulatory Strategy. Neurol Res Int. 2017;2017:3549291. doi: 10.1155/2017/3549291. Epub 2017 Apr 6.
Results Reference
derived
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Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy
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