- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06451094
Effectiveness Transfer Energy Capacitive and Resistive Therapy in Patients With Carpal Tunnel Syndrome
Comparison of the Effectiveness of Ultrasound and Transfer Energy Capacitive and Resistive (TECAR) Therapy in Patients With Carpal Tunnel Syndrome
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Özge TEZEN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: US therapy, paraffin therapy
Group 1, US therapy to the palmar region of the wrist, 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions and Paraffin therapy to the wrist area by dipping the hand 3 times into a paraffin bath and removing it, covering the entire wrist with paraffin, and waiting for 15 min (2 weeks, 5 times a week, for a total of 10 sessions).
|
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.
|
|
Experimental: TECAR therapy, paraffin therapy
Group 2, TECAR therapy to the palmar region of the wrist, 5 min capacitive (CAP) and 10 min resistive (RES), 3 days a week for 2 weeks, for a total of 6 sessions and Paraffin therapy to the wrist area by dipping the hand 3 times into a paraffin bath and removing it, covering the entire wrist with paraffin, and waiting for 15 min (2 weeks, 5 times a week, for a total of 10 sessions).
|
Transfer Energy Capacitative and Resistive Therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
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0 min , 10 is maximum pain score
|
baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
|
|
Boston Carpal Tunnel Questionnaire (BCTQ)
Time Frame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median nerve cross-sectional area (CSA) measurement
Time Frame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
|
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
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baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2-23-3833
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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