- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mahmoud Hamada Mohamed Associate Professor, Ph.D
- Phone Number: 01096968910
- Email: mahmoud.mohamed@fpt.bu.edu.eg
Study Locations
-
-
Benha
-
Banhā, Benha, Egypt, 11503
- Recruiting
- Outpatient clinic, faculty of Physical Therapy, Benha university
-
Contact:
- Mahmoud Hamada Mohamed Associate Professor, Ph.D
- Phone Number: 01096968910
- Email: mahmoud.mohamed@fpt.bu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Patient-Rated Elbow Evaluation (PREE) Score
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colour Ultrasonography
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Telerehabilitation of ME 2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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