NCT07582510

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Dec 2026

First Submitted

Initial submission to the registry

May 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 14, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 3, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

medial epicondylitistelerehabilitationgrip strengthPatient-Rated Elbow EvaluationQuick DASH

Outcome Measures

Primary Outcomes (1)

  • Change in Patient-Rated Elbow Evaluation (PREE) Score

    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 Outcomes (3)

  • Colour Ultrasonography

    Baseline and 8 Weeks

  • Grip Strength (hand dynamometer)

    Baseline and 8 Weeks

  • Pain Intensity (Visual Analog Scale)

    Baseline and 8 Weeks

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Participants will receive a structured home-based rehabilitation program delivered through digital platforms with weekly remote supervision.

Other: Telerehabilitation Exercise Program

Supervised Physiotherapy

ACTIVE COMPARATOR

Participants will receive clinic-based physiotherapy sessions including supervised exercises.

Other: Supervised Physiotherapy Program

Interventions

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.

Telerehabilitation

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

Supervised Physiotherapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, faculty of Physical Therapy, Benha university

Banhā, Benha, 11503, Egypt

RECRUITING

MeSH Terms

Conditions

Elbow Tendinopathy

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Central Study Contacts

Mahmoud Hamada Mohamed Associate Professor, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors, including the ultrasound examiner, will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to either telerehabilitation or supervised physiotherapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 13, 2026

Study Start

May 14, 2026

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations