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Telerehabilitation vs Supervised Physiotherapy for Medial Epicondylitis (TELE-ME)

14. mai 2026 oppdatert av: Mahmoud Hamada Mohamed, Benha University

Effectiveness of Telerehabilitation Versus Supervised Physiotherapy on Pain, Function, Strength, and Musculoskeletal Ultrasound Parameters in Patients With Medial Epicondylitis: A Randomized Controlled Trial

This randomized controlled trial aims to compare the effectiveness of telerehabilitation and supervised physiotherapy in patients with medial epicondylitis. The primary outcome is improvement in pain and function using the Patient-Rated Elbow Evaluation (PREE). Secondary outcomes include pain intensity, grip strength, musculoskeletal ultrasound findings, adherence, and upper limb disability measured by Quick DASH.

Studieoversikt

Detaljert beskrivelse

Medial epicondylitis is a tendinopathy affecting the common flexor origin of the elbow, resulting in pain and functional limitation. Supervised physiotherapy is commonly used; however, telerehabilitation provides an accessible and scalable alternative. Evidence comparing these two delivery models is limited.

This randomized controlled trial will compare telerehabilitation and supervised physiotherapy over an 8-week intervention period. Clinical outcomes will be assessed using PREE, pain intensity, grip strength, and QuickDASH. Musculoskeletal ultrasound will be used to evaluate tendon structural characteristics. The study will also explore the relationship between imaging findings and clinical outcomes.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Benha
      • Banhā, Benha, Egypt, 11503
        • Rekruttering
        • Outpatient clinic, faculty of Physical Therapy, Benha university
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Age 18 to 60 years
  • Clinical diagnosis of medial epicondylitis
  • Symptoms duration ≥6 weeks
  • Pain with resisted wrist flexion
  • Local tenderness at medial epicondyle

Exclusion Criteria:

  • Previous elbow surgery
  • Corticosteroid injection within the past 3 months
  • Cervical radiculopathy
  • Systemic inflammatory disease
  • Bilateral symptoms

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Telerehabilitation
Participants will receive a structured home-based rehabilitation program delivered through digital platforms with weekly remote supervision.
Participants will perform a home-based progressive loading program targeting the wrist flexor-pronator muscles three times per week for 8 weeks. The protocol will progress from isometric exercises in weeks 1-2 (4-5 × 30-45 s holds), to eccentric loading in weeks 3-4 (3 × 15 repetitions), followed by combined concentric-eccentric training in weeks 5-6 (3-4 × 10-12 repetitions), and heavy slow resistance in weeks 7-8 (3-4 × 6-8 repetitions at ~70-85% 1RM). Exercise intensity will be guided by a pain-monitoring model (≤5/10), with progression based on tolerance. Participants will receive weekly video consultations, instructional materials, and adherence will be tracked via digital logs.
Aktiv komparator: Supervised Physiotherapy
Participants will receive clinic-based physiotherapy sessions including supervised exercises.
Participants will undergo an identical progressive loading program targeting the wrist flexor-pronator muscles, administered three times per week for 8 weeks under direct physiotherapist supervision. The intervention will follow the same staged progression: will progress from isometric exercises in weeks 1-2 (4-5 × 30-45 s holds), to eccentric loading in weeks 3-4 (3 × 15 repetitions), followed by combined concentric-eccentric training in weeks 5-6 (3-4 × 10-12 repetitions), and heavy slow resistance in weeks 7-8 (3-4 × 6-8 repetitions at ~70-85% 1RM). Exercise intensity will be guided by a pain-monitoring model (≤5/10), with progression based on tolerance. This supervised approach ensures correct technique, optimal load progression and adherence to the protocol

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Patient-Rated Elbow Evaluation (PREE) Score
Tidsramme: Baseline and 8 Weeks
The PREE is a 15-item questionnaire assessing pain and functional disability. Scores range from 0 to 100, with higher scores indicating worse pain and function.
Baseline and 8 Weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Colour Ultrasonography
Tidsramme: Baseline and 8 Weeks
Change in tendon hypervascularity and hypoechogenicity will be assessed using color Doppler ultrasonography and graded on a four-point scale (Grade 1-Grade 4). Ultrasonographic evaluation will include assessment of hypoechoic changes within the common flexor tendon, tendon sheath thickening, partial or full-thickness tendon ruptures, neovascularization detected by Doppler imaging, and cortical irregularities or damage at the medial epicondyle.
Baseline and 8 Weeks
Grip Strength (hand dynamometer)
Tidsramme: Baseline and 8 Weeks
Measured using a hand dynamometer. Hand grip strength will be assessed using a calibrated hydraulic hand dynamometer with participants seated comfortably, shoulder adducted and neutrally rotated, elbow flexed to 90°, forearm in neutral position, and wrist positioned between 0-30° extension according to standardized testing procedures. Participants will be instructed to perform maximal voluntary grip contraction for approximately 3-5 seconds. Three trials will be recorded for the affected upper limb with a 30-60 second rest interval between attempts, and the mean value in kilograms (kg) will be used for statistical analysis.
Baseline and 8 Weeks
Pain Intensity (Visual Analog Scale)
Tidsramme: Baseline and 8 Weeks
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS) ranging from 0 ("no pain") to 10 ("worst imaginable pain") at rest and during resisted wrist flexion.
Baseline and 8 Weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. mai 2026

Primær fullføring (Antatt)

15. november 2026

Studiet fullført (Antatt)

15. desember 2026

Datoer for studieregistrering

Først innsendt

3. mai 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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