- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07587931
Concentric vs Eccentric Full Can Exercise in Partial Rotator Cuff Tears (FULLCAN-PRCT)
Comparison of the Effects of Concentric and Eccentric Full Can Exercises on Supraspinatus Muscle Architecture in Individuals With Partial Rotator Cuff Tears
This study aims to compare the effects of concentric and eccentric full can exercises on supraspinatus muscle architecture in individuals with partial rotator cuff tears.
Rotator cuff tears are a common cause of shoulder pain and functional limitation. The supraspinatus muscle plays a key role in shoulder movement and stability, and its structure may be affected in individuals with partial tears.
Exercise-based rehabilitation is widely used in the conservative management of these conditions. The full can exercise is commonly prescribed to selectively activate the supraspinatus muscle. However, the effects of different contraction types, specifically concentric and eccentric exercises, on muscle structure and clinical outcomes are not fully understood.
In this study, participants will be randomly assigned to either a concentric or eccentric full can exercise group. Both groups will receive a standard physiotherapy program, including therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS), in addition to the assigned exercise protocol.
The intervention will last for 6 weeks, with sessions performed three times per week. Outcomes will be assessed before and after the intervention.
The primary outcome is the change in supraspinatus muscle pennation angle measured by ultrasound imaging. Secondary outcomes include muscle architecture parameters, pain intensity, range of motion, muscle strength, functional status, and kinesiophobia.
The findings of this study may help improve exercise selection in the rehabilitation of individuals with rotator cuff tears.
연구 개요
상태
상세 설명
Study Design and Setting This study is designed as a prospective, randomized, assessor-blinded, parallel-group clinical trial. The study will be conducted at Firat University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, and Fethi Sekin City Hospital, Department of Physical Medicine and Rehabilitation.
Participants A total of 60 individuals aged between 18 and 65 years with a diagnosis of partial supraspinatus tendon tear confirmed by ultrasound or magnetic resonance imaging will be included. Participants will be randomly allocated into two groups (n=30 per group).
Randomization and Blinding Participants will be assigned to groups using a computer-generated randomization sequence. Allocation will be concealed using sealed, opaque envelopes. Outcome assessments will be performed by a blinded assessor.
Interventions
Both groups will receive a standard physiotherapy program including:
Therapeutic ultrasound Transcutaneous electrical nerve stimulation (TENS) Standard shoulder rehabilitation exercises
The only difference between groups will be the contraction type of the full can exercise:
Concentric Group: Emphasis on the lifting phase (approximately 2 seconds), with minimal eccentric loading Eccentric Group: Emphasis on the lowering phase (approximately 4 seconds), with minimal concentric loading
All interventions will be applied 3 times per week for 6 weeks (total of 18 sessions).
Outcome Measures
Primary Outcome:
Supraspinatus muscle pennation angle measured by B-mode ultrasonography
Secondary Outcomes:
Muscle architecture parameters (fiber length, physiological cross-sectional area) Pain intensity (Visual Analog Scale) Range of motion (goniometric assessment) Muscle strength (hand-held dynamometry) Functional status (DASH, SPADI) Kinesiophobia (Tampa Scale of Kinesiophobia)
Assessments will be performed at baseline (T0) and at the end of the 6-week intervention (T1).
Sample Size and Statistical Analysis Sample size calculation was based on the primary outcome (pennation angle change), assuming an effect size of 0.70, alpha of 0.05, and power of 80%. A minimum of 26 participants per group was required; therefore, 30 participants per group will be recruited to account for potential dropouts.
Data will be analyzed using appropriate statistical methods including mixed-design ANOVA for group and time comparisons. Non-parametric tests will be used if assumptions are not met. Intention-to-treat analysis will be applied.
Ethical Considerations The study will be conducted in accordance with ethical principles for human research. Informed consent will be obtained from all participants prior to inclusion.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muharrem Gökhan Beydağı, PhD
- 전화번호: +905323581105
- 이메일: mgbeydagi@firat.edu.tr
연구 장소
-
-
MErkez
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Elâzığ, MErkez, 터키 (Türkiye), 23200
- 모병
- Firat University
-
연락하다:
- Muharrem Gökhan Beydağı, PhD
- 전화번호: 05323581105
- 이메일: mgbeydagi@firat.edu.tr
-
연락하다:
- Muhammet Şahin Elbastı, MD
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수석 연구원:
- Muhammet Şahin Elbastı, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged between 18 and 65 years
- Diagnosed with partial supraspinatus tendon tear confirmed by ultrasound or magnetic resonance imaging
- Shoulder pain lasting at least 3 months
- Pain intensity ≥3 on the Visual Analog Scale (VAS)
- Willing to participate and provide informed consent
Exclusion Criteria:
- Full-thickness rotator cuff tear
- History of shoulder surgery
- Shoulder instability
- Neurological disorders
- Rheumatological diseases
- Corticosteroid injection within the last 3 months
- Inability to adhere to the exercise program
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 |
|---|---|
|
활성 비교기: Concentric Exercise Group
Participants will receive a standard physiotherapy program including ultrasound, TENS, and shoulder rehabilitation exercises, combined with concentric full can exercises.
The concentric phase (lifting) will be emphasized, while the eccentric phase will be minimally loaded.
|
A strengthening exercise performed in the scapular plane with emphasis on the eccentric phase.
The lowering phase is performed slowly in approximately 4 seconds against resistance, while the concentric phase is minimized.
Exercises are performed 3 times per week for 6 weeks.
Includes therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), and standard shoulder rehabilitation exercises applied to all participants.
|
|
활성 비교기: Eccentric Exercise Group
Participants will receive a standard physiotherapy program including ultrasound, TENS, and shoulder rehabilitation exercises, combined with eccentric full can exercises.
The eccentric phase (lowering) will be emphasized, while the concentric phase will be minimally loaded.
|
Includes therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), and standard shoulder rehabilitation exercises applied to all participants.
A strengthening exercise performed in the scapular plane with emphasis on the eccentric phase.
The lowering phase is performed slowly in approximately 4 seconds against resistance, while the concentric phase is minimized.
Exercises are performed 3 times per week for 6 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Supraspinatus Muscle Pennation Angle
기간: Baseline and 6 weeks
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The pennation angle of the supraspinatus muscle will be measured using B-mode ultrasonography. Measurements will be obtained at baseline (T0) and after 6 weeks (T1). The change between time points will be analyzed. Supraspinatus Muscle Pennation Angle:
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Baseline and 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Supraspinatus Muscle Fiber Length
기간: Baseline and 6 weeks
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Measured using B-mode ultrasonography at baseline and after 6 weeks. Supraspinatus Fascicle Length:
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Baseline and 6 weeks
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Change in Physiological Cross-Sectional Area of Supraspinatus
기간: Baseline and 6 weeks
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Measured via ultrasound imaging at baseline and after 6 weeks. Physiological Cross-Sectional Area (PCSA):
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Baseline and 6 weeks
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Change in Pain Intensity (VAS)
기간: Baseline and 6 weeks
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Pain intensity will be assessed using the Visual Analog Scale (0-10 cm). Visual Analog Scale for Pain:
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Baseline and 6 weeks
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Change in Shoulder Range of Motion
기간: Baseline and 6 weeks
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Measured using a goniometer for flexion, abduction, internal and external rotation. Shoulder Range of Motion:
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Baseline and 6 weeks
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Change in Shoulder Muscle Strength
기간: Baseline and 6 weeks
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Measured using a hand-held dynamometer during isometric contraction. Shoulder Muscle Strength
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Baseline and 6 weeks
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Change in Functional Status (DASH Scores)
기간: Baseline and 6 weeks
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Functional status will be assessed using DASH questionnaires. Disabilities of the Arm, Shoulder and Hand (DASH) Score
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Baseline and 6 weeks
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Change in Functional Status (SPADI Scores)
기간: Baseline and 6 weeks
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Functional status will be assessed using SPADI questionnaires. Shoulder Pain and Disability Index (SPADI):
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Baseline and 6 weeks
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Change in Kinesiophobia (Tampa Scale)
기간: Baseline and 6 weeks
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Measured using the Tampa Scale of Kinesiophobia. Tampa Scale for Kinesiophobia:
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Baseline and 6 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
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