- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mahmoud Hamada Mohamed Associate Professor, Ph.D
- 전화번호: 01096968910
- 이메일: mahmoud.mohamed@fpt.bu.edu.eg
연구 장소
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Benha
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Banhā, Benha, 이집트, 11503
- 모병
- Outpatient clinic, faculty of Physical Therapy, Benha university
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연락하다:
- Mahmoud Hamada Mohamed Associate Professor, Ph.D
- 전화번호: 01096968910
- 이메일: mahmoud.mohamed@fpt.bu.edu.eg
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Patient-Rated Elbow Evaluation (PREE) Score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Colour Ultrasonography
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Telerehabilitation of ME 2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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