Carpal Tunnel SyndromeNCT06451094
Effectiveness Transfer Energy Capacitive and Resistive Therapy in Patients With Carpal Tunnel Syndrome
A study testing US therapy and TECAR in people with Carpal Tunnel Syndrome and Energy Transfer Capacitative and Resistive Therapy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome, Energy Transfer Capacitative and Resistive Therapy
- What is being tested?
- US therapy and TECAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- US therapy, TECAR
- Keywords
- Carpal tunnel syndrome, TECAR therapy, median nerve CSA
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US therapyDevice
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.
TECARDevice
Transfer Energy Capacitative and Resistive Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: TECAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
0 min , 10 is maximum pain score
Measured: 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.
Measured: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
Secondary outcomes (1)
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
Measured: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start15 May 2023
- Primary completion15 Nov 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451094
- Sponsor's protocol ID
- E2-23-3833
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40106005
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound and Transfer Energy Capacitive and Resistive (TECAR) Therapy in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06451094
- Acronym / sponsor ID
- E2-23-3833
- Keywords
- Carpal tunnel syndrome, TECAR therapy, median nerve CSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US therapy, paraffin therapy | Experimental | Device: US therapyGroup 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). |
| TECAR therapy, paraffin therapy | Experimental | Device: TECARGroup 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US therapy3 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. | Device | US therapy, paraffin therapy |
| TECARTransfer Energy Capacitative and Resistive Therapy | Device | TECAR therapy, paraffin therapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
0 min , 10 is maximum pain score
Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
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.
1 secondary outcome
Median nerve cross-sectional area (CSA) measurement
Time frame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 40106005Tezen 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.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US therapy and TECAR in people with Carpal Tunnel Syndrome and Energy Transfer Capacitative and Resistive Therapy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.