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Clinical Trials/NCT03062722
NCT03062722
Completed
Not Applicable

Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory

Ivan Segura Duran0 sites55 target enrollmentJanuary 1, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Ivan Segura Duran
Enrollment
55
Primary Endpoint
Levine Severity Scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2015
End Date
July 1, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ivan Segura Duran
Responsible Party
Sponsor Investigator
Principal Investigator

Ivan Segura Duran

M.D.

University of Guadalajara

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.

Outcomes

Primary Outcomes

Levine Severity Scale

Time Frame: 2 years follow up

pain grades with 5 grades of intensity

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