NCT06451094

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 3, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

Carpal tunnel syndromeTECAR therapymedian nerve CSA

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale (VAS)

    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)

    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 Outcomes (1)

  • Median nerve cross-sectional area (CSA) measurement

    baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month

Study Arms (2)

US therapy, paraffin therapy

EXPERIMENTAL

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).

Device: US therapy

TECAR therapy, paraffin therapy

EXPERIMENTAL

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).

Device: TECAR

Interventions

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.

US therapy, paraffin therapy
TECARDEVICE

Transfer Energy Capacitative and Resistive Therapy

TECAR therapy, paraffin therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özge TEZEN

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Tezen O, Ata AM, Uzun O, Cakir F, Yasar E. Comparison of the effectiveness of ultrasound and transfer energy capacitive and resistive (TECAR) therapy in patients with carpal tunnel syndrome. Lasers Med Sci. 2025 Mar 19;40(1):147. doi: 10.1007/s10103-025-04412-z.

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 10, 2024

Study Start

May 15, 2023

Primary Completion

November 15, 2023

Study Completion

February 15, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

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