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Evaluation of the Effectiveness of Capacitive and Resistive Energy Transfer Therapy for Lateral Epicondylitis

9 июня 2026 г. обновлено: Merve Önoğul Özmen, Gaziantep City Hospital

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.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

62

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Merve ÖNOĞUL ÖZMEN, Medıcal Doctor
  • Номер телефона: (0312)7970000 +905398981401
  • Электронная почта: drmerveonogul@gmail.com

Учебное резервное копирование контактов

  • Имя: Ali GÜNERİ, Medıcal Doctor
  • Номер телефона: (0312)7970000 +905077512047
  • Электронная почта: draliguneri@gmail.com

Места учебы

  • Турция (Туркие)
    • Gaziantep
      • Gaziantep, Gaziantep, Турция (Туркие), 06170
        • Рекрутинг
        • Gaziantep City Hospital
        • Контакт:
          • Merve ÖNOĞUL ÖZMEN, Medical Doctor
          • Номер телефона: 05398981401
          • Электронная почта: drmerveonogul@gmail.com
        • Главный следователь:
          • Merve ÖNOĞUL ÖZMEN, Medical Doctor
        • Младший исследователь:
          • Ali GÜNERİ, Medical Doctor

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: TECAR Therapy + Exercise
Participants will receive active TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Устройство: TECAR Therapy + Exercise
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.
Фальшивый компаратор: Sham TECAR Therapy + Exercise
Participants will receive sham TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Устройство: Sham TECAR Therapy + Exercise
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Visual Analog Scale (VAS)
Временное ограничение: 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.
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Pressure Pain Threshold Measurement with Algometry
Временное ограничение: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
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.
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Ultrasonographic evaluation
Временное ограничение: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
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.
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
Handgrip Strength
Временное ограничение: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
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.
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)
Временное ограничение: 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) 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.
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)
Временное ограничение: Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).
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.
Baseline (pre-treatment), Week 2 (post-treatment), Week 6 (1-month follow-up), and Week 10 (2-month follow-up).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Gaziantep City Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

11 мая 2026 г.

Первичное завершение (Оцененный)

11 декабря 2026 г.

Завершение исследования (Оцененный)

11 мая 2027 г.

Даты регистрации исследования

Первый отправленный

3 июня 2026 г.

Впервые представлено, что соответствует критериям контроля качества

3 июня 2026 г.

Первый опубликованный (Действительный)

8 июня 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

11 июня 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • HÜ-KAEK-2026-00096

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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.

Сроки обмена IPD

Data will be available after publication of the study results.

Критерии совместного доступа к IPD

De-identified individual participant data and supporting documents will be available to qualified researchers upon reasonable request to the principal investigator. Access will be granted for scientific research purposes after approval of the research proposal. Data will be shared through secure electronic transfer.

Совместное использование IPD Поддерживающий тип информации

  • САП
  • МКФ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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