Lateral EpicondylitisNCT07634224
Evaluation of the Effectiveness of Capacitive and Resistive Energy Transfer Therapy for Lateral Epicondylitis
A study testing TECAR Therapy + Exercise in people with Lateral Epicondylitis and Capacitive and Resistive Electric Transfer Therapy, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of Capacitive and Resistive Energy Transfer (TECAR) therapy in patients with lateral epicondylitis. Participants will be randomly assigned to either a TECAR plus exercise group or a sham TECAR plus exercise group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Capacitive and Resistive Electric Transfer Therapy, Exercise
- What is being tested?
- TECAR Therapy + Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2026to 11 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lateral epicondylitis who have experienced elbow pain for at least 6 weeks and have at least two positive provocative tests (Cozen's, Mill's, or Maudsley's test).
- Age between 18 and 65 years.
- Unilateral pain and tenderness over the lateral epicondyle lasting longer than 6 weeks.
- Clinically diagnosed lateral epicondylitis.
- No cognitive impairment.
- Willingness to participate and provide informed consent.
Who cannot join
- History of interventional injection to the affected elbow within the previous 3 months.
- Receipt of physical therapy for the affected elbow within the previous 3 months.
- Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous 2 weeks.
- History of fracture or surgery involving the affected elbow.
- Presence of a chronic inflammatory disease.
- History of malignancy.
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- Active infection.
- Pregnancy.
- Presence of a cardiac pacemaker or other electronic implant.
- Coagulation disorders.
- Cervical radiculopathy, entrapment neuropathy, or peripheral nerve injury.
- Body mass index (BMI) ≥ 35 kg/m².
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep City Hospital
Gaziantep, Gaziantep, 06170
Merve ÖNOĞUL ÖZMEN, Medical Doctor, 05398981401, drmerveonogul@gmail.com
Merve ÖNOĞUL ÖZMEN, Medical Doctor
About this study
Official title: Effectiveness of Capacitive and Resistive Energy Transfer Therapy in Patients With Lateral Epicondylitis: A Sham-Controlled, Double-Blind Randomized Clinical Trial
This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of Capacitive and Resistive Energy Transfer (TECAR) therapy in patients with lateral epicondylitis. Participants will be randomly assigned to either a TECAR plus exercise group or a sham TECAR plus exercise group.
Both groups will receive a standardized home exercise program including elbow and wrist range-of-motion, stretching, eccentric strengthening, and handgrip strengthening exercises. The TECAR group will additionally receive active TECAR therapy, while the control group will receive sham TECAR treatment using the same device and treatment protocol without therapeutic energy delivery.
Outcome assessments will be performed by a blinded evaluator at baseline, immediately after treatment, and at 1- and 2-month follow-up visits. The study aims to determine whether TECAR therapy provides additional benefits in pain relief, functional improvement, and clinical outcomes when combined with exercise therapy in patients with lateral epicondylitis.
Read the detailed description
This study is planned as a prospective, randomized, double-blind, sham-controlled clinical trial involving patients diagnosed with lateral epicondylitis who present to the Physical Medicine and Rehabilitation Outpatient Clinic of Gaziantep City Hospital.
Participants will be randomly allocated into two groups using a computer-generated randomization method:
- Group 1: TECAR therapy + exercise group
- Group 2: Sham TECAR therapy + exercise group
All participants in both groups will receive a home-based exercise program consisting of elbow and wrist range-of-motion exercises, stretching exercises, eccentric strengthening exercises, and handgrip strengthening exercises. The exercise program will be explained in detail by a physiotherapist, and participants will be instructed to perform each exercise 10 repetitions, three times daily, throughout the treatment period. Adherence to the exercise program will be monitored through weekly telephone follow-ups and daily exercise log sheets completed by the participants at home. Compliance with regular splint use will also be monitored.
Outcome assessments will be conducted by a blinded evaluator at baseline, immediately after completion of treatment, and at the 1st and 2nd months following treatment.
TECAR Group (Active Treatment Group):
In addition to the exercise program, participants in the TECAR group will receive TECAR therapy consisting of a capacitive mode application at a frequency of 500 kHz for 5 minutes and a resistive mode application at a frequency of 500 kHz for 10 minutes, for a total treatment duration of 15 minutes per session. Treatment will be administered five sessions per week for two weeks, resulting in a total of 10 sessions. The capacitive mode will be applied to target superficial soft tissues, whereas the resistive mode will be used to affect deeper and higher-impedance connective tissues, such as the common extensor tendon.
Sham TECAR Group (Control Group):
Participants in the sham TECAR group will be treated using the same device, electrode, application area, treatment duration, and procedural protocol as the active treatment group. However, the device will be configured to deliver no therapeutic energy, thereby serving as a sham intervention.
- Being tested
- TECAR Therapy + Exercise, Sham TECAR Therapy + Exercise
- Keywords
- Lateral epicondylitis, Capacitive and resistive energy transfer therapy (TECAR), Exercise therapy, Rehabilitation, Randomized controlled trial
- Medical subject headings
- Tennis Elbow, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAR Therapy + ExerciseDevice
Participants assigned to this group will receive active Capacitive and Resistive Electrical Transfer (TECAR) therapy in addition to a standard home exercise program. Active TECAR therapy will be administered five times a week for two weeks (10 sessions in total), with each session lasting 15 minutes.
Sham TECAR Therapy + ExerciseDevice
Participants assigned to this group will receive sham TECAR therapy in addition to the same standardized home exercise program. The sham intervention will be delivered using the same device, applicator, treatment duration, and application procedures as the active treatment; However, no therapeutic energy will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| TECAR Therapy + Exercise | Experimental | Participants will receive active TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis. Receives: Device: TECAR Therapy + Exercise |
| Sham TECAR Therapy + Exercise | Sham comparator | Participants will receive sham TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis. Receives: Device: Sham TECAR Therapy + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is the most commonly used outcome measure for assessing pain intensity in studies involving lateral epicondylitis. It typically consists of a 10-cm horizontal line anchored by the descriptors "no pain" and "worst imaginable pain" at each end. Participants are asked to mark the point on the line that best represents their perceived pain intensity, and the distance from the left endpoint to the marked point is recorded in centimeters. In the present study, the VAS will be used to assess pain experienced in the elbow region during activity.
Measured: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Secondary outcomes (5)
Pressure Pain Threshold Measurement with Algometry
An algometer is a device used to assess pain sensitivity by measuring the Pressure Pain Threshold (PPT), defined as the minimum pressure required to be perceived as painful. Using a 1 cm² probe, pressure is applied perpendicular to the skin at a rate of 1 kg/s. Participants are instructed to indicate when the sensation changes from pressure to pain. PPT measurement provides a quantitative assessment of pain sensitivity and is widely used in clinical practice.
Measured: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Ultrasonographic evaluation
Ultrasonographic assessments will be performed by an experienced physiatrist blinded to treatment allocation. Participants will be examined in a seated position with the elbow flexed to approximately 90°, the forearm pronated, and the arm supported. Imaging will be conducted using a 7-12 MHz linear transducer, with the common extensor tendon (CET) aligned along its longitudinal axis. CET thickness will be measured at a standardized point located approximately 10 mm distal to its attachment on the lateral epicondyle. In addition to tendon thickness, tendon heterogeneity, focal hypoechoic areas, calcifications, tears, and enthesitis will be evaluated and recorded.
Measured: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Handgrip Strength
Handgrip strength will be measured in kilograms using a hand dynamometer. During the assessment, participants will be seated with the shoulder adducted and in neutral rotation, the elbow flexed to 90°, and the forearm and wrist in a neutral position, with the elbow supported. Participants will be instructed to squeeze the dynamometer up to their pain threshold. Three measurements will be obtained, and the mean value will be recorded.
Measured: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to assess pain and functional disability in patients with lateral epicondylitis. It consists of three subscales: pain (5 items), usual activities (4 items), and specific activities (6 items). Each item is scored on a scale from 0 to 10, with higher scores indicating greater pain or difficulty. The pain subscale ranges from 0 to 50, while the functional subscale ranges from 0 to 50. The total PRTEE score is calculated by summing the pain and functional scores, yielding a total score between 0 and 100, with higher scores indicating greater pain and functional impairment.
Measured: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Quick Disabilities Of The Arm, Shoulder And Hand (Quick-DASH)
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire is a shortened version of the 30-item DASH questionnaire used to assess activity limitations and participation restrictions associated with upper extremity musculoskeletal disorders. It consists of 11 items evaluating difficulty experienced during daily activities over the previous week. Each item is scored on a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to perform). The total score ranges from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start11 May 2026
- Primary completion11 Dec 2026 (estimated)
- Study completion11 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups using a computer-generated randomization sequence. The intervention group will receive active Capacitive and Resistive Electric Transfer (TECAR) therapy in addition to a standardized home exercise program, while the control group will receive sham TECAR therapy combined with the same exercise program. Outcome assessments will be performed by a blinded evaluator at baseline, immediately after treatment, and at 1- and 2-month follow-up visits. The study is designed to evaluate the additional effects of TECAR therapy on clinical outcomes in patients with lateral epicondylitis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Önoğul Özmen, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634224
- Sponsor's protocol ID
- HÜ-KAEK-2026-00096
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) generated and analyzed during the current study will not be publicly shared. However, de-identified data may be made available by the corresponding author upon reasonable request, subject to ethical approval and institutional data-sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Capacitive and Resistive Energy Transfer Therapy in Patients With Lateral Epicondylitis: A Sham-Controlled, Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07634224
- Acronym / sponsor ID
- HÜ-KAEK-2026-00096
- Keywords
- Lateral epicondylitis, Capacitive and resistive energy transfer therapy (TECAR), Exercise therapy, Rehabilitation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 May 2027 (estimated)
- First posted
- 8 Jun 2026 (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.
This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy of Capacitive and Resistive Energy Transfer (TECAR) therapy in patients with lateral epicondylitis. Participants will be randomly assigned to either a TECAR plus exercise group or a sham TECAR plus exercise group.
Both groups will receive a standardized home exercise program including elbow and wrist range-of-motion, stretching, eccentric strengthening, and handgrip strengthening exercises. The TECAR group will additionally receive active TECAR therapy, while the control group will receive sham TECAR treatment using the same device and treatment protocol without therapeutic energy delivery.
Outcome assessments will be performed by a blinded evaluator at baseline, immediately after treatment, and at 1- and 2-month follow-up visits. The study aims to determine whether TECAR therapy provides additional benefits in pain relief, functional improvement, and clinical outcomes when combined with exercise therapy in patients with lateral epicondylitis.
Detailed description
This study is planned as a prospective, randomized, double-blind, sham-controlled clinical trial involving patients diagnosed with lateral epicondylitis who present to the Physical Medicine and Rehabilitation Outpatient Clinic of Gaziantep City Hospital.
Participants will be randomly allocated into two groups using a computer-generated randomization method:
- Group 1: TECAR therapy + exercise group
- Group 2: Sham TECAR therapy + exercise group
All participants in both groups will receive a home-based exercise program consisting of elbow and wrist range-of-motion exercises, stretching exercises, eccentric strengthening exercises, and handgrip strengthening exercises. The exercise program will be explained in detail by a physiotherapist, and participants will be instructed to perform each exercise 10 repetitions, three times daily, throughout the treatment period. Adherence to the exercise program will be monitored through weekly telephone follow-ups and daily exercise log sheets completed by the participants at home. Compliance with regular splint use will also be monitored.
Outcome assessments will be conducted by a blinded evaluator at baseline, immediately after completion of treatment, and at the 1st and 2nd months following treatment.
TECAR Group (Active Treatment Group):
In addition to the exercise program, participants in the TECAR group will receive TECAR therapy consisting of a capacitive mode application at a frequency of 500 kHz for 5 minutes and a resistive mode application at a frequency of 500 kHz for 10 minutes, for a total treatment duration of 15 minutes per session. Treatment will be administered five sessions per week for two weeks, resulting in a total of 10 sessions. The capacitive mode will be applied to target superficial soft tissues, whereas the resistive mode will be used to affect deeper and higher-impedance connective tissues, such as the common extensor tendon.
Sham TECAR Group (Control Group):
Participants in the sham TECAR group will be treated using the same device, electrode, application area, treatment duration, and procedural protocol as the active treatment group. However, the device will be configured to deliver no therapeutic energy, thereby serving as a sham intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups using a computer-generated randomization sequence. The intervention group will receive active Capacitive and Resistive Electric Transfer (TECAR) therapy in addition to a standardized home exercise program, while the control group will receive sham TECAR therapy combined with the same exercise program. Outcome assessments will be performed by a blinded evaluator at baseline, immediately after treatment, and at 1- and 2-month follow-up visits. The study is designed to evaluate the additional effects of TECAR therapy on clinical outcomes in patients with lateral epicondylitis.
| Arm | Type | Receives |
|---|---|---|
| TECAR Therapy + Exercise | Experimental | Device: TECAR Therapy + ExerciseParticipants will receive active TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis. |
| Sham TECAR Therapy + Exercise | Sham comparator | Device: Sham TECAR Therapy + ExerciseParticipants will receive sham TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with lateral epicondylitis who have experienced elbow pain for at least 6 weeks and have at least two positive provocative tests (Cozen's, Mill's, or Maudsley's test).
- Age between 18 and 65 years.
- Unilateral pain and tenderness over the lateral epicondyle lasting longer than 6 weeks.
- Clinically diagnosed lateral epicondylitis.
- No cognitive impairment.
Key exclusion criteria (12 listed)
- History of interventional injection to the affected elbow within the previous 3 months.
- Receipt of physical therapy for the affected elbow within the previous 3 months.
- Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) within the previous 2 weeks.
- History of fracture or surgery involving the affected elbow.
- Presence of a chronic inflammatory disease.
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 |
|---|---|---|
| TECAR Therapy + ExerciseParticipants assigned to this group will receive active Capacitive and Resistive Electrical Transfer (TECAR) therapy in addition to a standard home exercise program. Active TECAR therapy will be administered five times a week for two weeks (10 sessions in total), with each session lasting 15 minutes. | Device | TECAR Therapy + Exercise |
| Sham TECAR Therapy + ExerciseParticipants assigned to this group will receive sham TECAR therapy in addition to the same standardized home exercise program. The sham intervention will be delivered using the same device, applicator, treatment duration, and application procedures as the active treatment; However, no therapeutic energy will be delivered. | Device | Sham TECAR Therapy + Exercise |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
The Visual Analog Scale (VAS) is the most commonly used outcome measure for assessing pain intensity in studies involving lateral epicondylitis. It typically consists of a 10-cm horizontal line anchored by the descriptors "no pain" and "worst imaginable pain" at each end. Participants are asked to mark the point on the line that best represents their perceived pain intensity, and the distance from the left endpoint to the marked point is recorded in centimeters. In the present study, the VAS will be used to assess pain experienced in the elbow region during activity.
5 secondary outcomes
Pressure Pain Threshold Measurement with Algometry
Time frame: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Ultrasonographic evaluation
Time frame: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Handgrip Strength
Time frame: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Quick Disabilities Of The Arm, Shoulder And Hand (Quick-DASH)
Time frame: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) generated and analyzed during the current study will not be publicly shared. However, de-identified data may be made available by the corresponding author upon reasonable request, subject to ethical approval and institutional data-sharing policies.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECAR Therapy + Exercise in people with Lateral Epicondylitis and Capacitive and Resistive Electric Transfer Therapy, run by Gaziantep City Hospital 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve ÖNOĞUL ÖZMEN, Medıcal Doctor (+905398981401 ext. (0312)7970000, drmerveonogul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.