- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07582510
Telerehabilitation vs Supervised Physiotherapy for Medial Epicondylitis (TELE-ME)
Effectiveness of Telerehabilitation Versus Supervised Physiotherapy on Pain, Function, Strength, and Musculoskeletal Ultrasound Parameters in Patients With Medial Epicondylitis: A Randomized Controlled Trial
Studieoversikt
Status
Intervensjon / Behandling
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mahmoud Hamada Mohamed Associate Professor, Ph.D
- Telefonnummer: 01096968910
- E-post: mahmoud.mohamed@fpt.bu.edu.eg
Studiesteder
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Benha
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Banhā, Benha, Egypt, 11503
- Rekruttering
- Outpatient clinic, faculty of Physical Therapy, Benha university
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Ta kontakt med:
- Mahmoud Hamada Mohamed Associate Professor, Ph.D
- Telefonnummer: 01096968910
- E-post: mahmoud.mohamed@fpt.bu.edu.eg
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Telerehabilitation
Participants will receive a structured home-based rehabilitation program delivered through digital platforms with weekly remote supervision.
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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.
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Aktiv komparator: Supervised Physiotherapy
Participants will receive clinic-based physiotherapy sessions including supervised exercises.
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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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Patient-Rated Elbow Evaluation (PREE) Score
Tidsramme: Baseline and 8 Weeks
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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.
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Baseline and 8 Weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Colour Ultrasonography
Tidsramme: Baseline and 8 Weeks
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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.
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Baseline and 8 Weeks
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Grip Strength (hand dynamometer)
Tidsramme: Baseline and 8 Weeks
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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.
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Baseline and 8 Weeks
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Pain Intensity (Visual Analog Scale)
Tidsramme: Baseline and 8 Weeks
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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.
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Baseline and 8 Weeks
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Telerehabilitation of ME 2026
Plan for individuelle deltakerdata (IPD)
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