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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Merve ÖNOĞUL ÖZMEN, Medıcal Doctor
  • Telefonnummer: (0312)7970000 +905398981401
  • E-mail: drmerveonogul@gmail.com

Undersøgelse Kontakt Backup

  • Navn: Ali GÜNERİ, Medıcal Doctor
  • Telefonnummer: (0312)7970000 +905077512047
  • E-mail: draliguneri@gmail.com

Studiesteder

  • Tyrkiet (Türkiye)
    • Gaziantep
      • Gaziantep, Gaziantep, Tyrkiet (Türkiye), 06170
        • Rekruttering
        • Gaziantep City Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Merve ÖNOĞUL ÖZMEN, Medical Doctor
        • Underforsker:
          • Ali GÜNERİ, Medical Doctor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TECAR Therapy + Exercise
Participants will receive active TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Enhed: 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.
Sham-komparator: Sham TECAR Therapy + Exercise
Participants will receive sham TECAR therapy combined with a standardized home exercise program for the treatment of lateral epicondylitis.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Visual Analog Scale (VAS)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pressure Pain Threshold Measurement with Algometry
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gaziantep City Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. maj 2026

Primær færdiggørelse (Anslået)

11. december 2026

Studieafslutning (Anslået)

11. maj 2027

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HÜ-KAEK-2026-00096

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Data will be available after publication of the study results.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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