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

9 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

62

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Merve ÖNOĞUL ÖZMEN, Medıcal Doctor
  • Número de teléfono: (0312)7970000 +905398981401
  • Correo electrónico: drmerveonogul@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Ali GÜNERİ, Medıcal Doctor
  • Número de teléfono: (0312)7970000 +905077512047
  • Correo electrónico: draliguneri@gmail.com

Ubicaciones de estudio

  • Turquía (Türkiye)
    • Gaziantep
      • Gaziantep, Gaziantep, Turquía (Türkiye), 06170
        • Reclutamiento
        • Gaziantep City Hospital
        • Contacto:
          • Merve ÖNOĞUL ÖZMEN, Medical Doctor
          • Número de teléfono: 05398981401
          • Correo electrónico: drmerveonogul@gmail.com
        • Investigador principal:
          • Merve ÖNOĞUL ÖZMEN, Medical Doctor
        • Sub-Investigador:
          • Ali GÜNERİ, Medical Doctor

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: TECAR Therapy + Exercise
Participants will receive active TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Dispositivo: 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.
Comparador falso: Sham TECAR Therapy + Exercise
Participants will receive sham TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Visual Analog Scale (VAS)
Periodo de tiempo: 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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pressure Pain Threshold Measurement with Algometry
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Gaziantep City Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de mayo de 2026

Finalización primaria (Estimado)

11 de diciembre de 2026

Finalización del estudio (Estimado)

11 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

8 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HÜ-KAEK-2026-00096

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

Data will be available after publication of the study results.

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • SAVIA
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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