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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06451094
Other study ID # E2-23-3833
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date February 15, 2024

Study information

Verified date June 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: The aim of this study was to evaluate the effect of Transfer Energy Capacitive and Resistive (TECAR) therapy on pain, symptom severity and function in patients diagnosed with carpal tunnel syndrome (CTS) based on clinical and electromyography (EMG) findings and to compare it with ultrasound therapy (US). Methods: A total of 42 patients aged between 18 and 65 years, were randomly divided into two groups; group 1, US therapy 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions, group 2 TECAR therapy 5 min capacitive (CAP) and 10 min resistive (RES), 3 days a week for 2 weeks, for a total of 6 sessions. Both groups received paraffin therapy and wrist orthosis. All Patients were evaluated using the Visual Analog Scale (VAS) for pain and paresthesia levels, the Boston Carpal Tunnel Questionnaire (BCTQ) for symptom severity and functional levels. Additionally, median nerve CSA was measured by ultrasound, at the baseline, post-treatment, first and third months.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date February 15, 2024
Est. primary completion date November 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18 years of age and over - had pain and numbness in their hands for more than 3 months were evaluated - Patients diagnosed with mild and moderate CTS by EMG Exclusion Criteria: - metabolic, rheumatic, or neurological diseases that could affect the median nerve cross-sectional area (CSA) - patients who had previously undergone surgery on the wrist, - oncology patients, - pregnancy, - pacemakers.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
US therapy
3 MHz probe with a BTL brand device at a dose of 1.5 watts/cm2 for 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions.
TECAR
Transfer Energy Capacitative and Resistive Therapy

Locations

Country Name City State
Turkey Özge TEZEN Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) 0 min , 10 is maximum pain score baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
Primary Boston Carpal Tunnel Questionnaire (BCTQ) symptom severity on functional tasks (Symptom Severity Scale), involving 11 items, and the other one on function status properly (Functional Status Scale), involving 8 items. Both subscales of BCTQ are scored between 1 and 5, and higher scores illustrate a greater degree of disability. baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
Secondary Median nerve cross-sectional area (CSA) measurement Median nerve CSA was measured by ultrasound on axial view at the scaphoid-pisiform level which is a reliable measurement for CTS. Three measurements were taken for analysis and the average value was recorded baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
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