Набор скоро начнётся NCT07587931

Concentric vs Eccentric Full Can Exercise in Partial Rotator Cuff Tears

Без фазы С лечением Partial Rotator Cuff Tears Rotator Cuff Injuries Shoulder Pain Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Concentric Full Can Exercise, Eccentric Full Can Exercise, Standard Physiotherapy Program.
Кому может быть актуально: Состояния в реестре: Partial Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain Syndrome. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of the Effects of Concentric and Eccentric Full Can Exercises on Supraspinatus Muscle Architecture in Individuals With Partial Rotator Cuff Tears

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Concentric Full Can Exercise
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.
Другое Eccentric Full Can Exercise
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.
Другое Standard Physiotherapy Program
Includes therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS), and standard shoulder rehabilitation exercises applied to all participants.

Первичные конечные точки

Change in Supraspinatus Muscle Pennation Angle [Срок оценки: Baseline and 6 weeks]

Вторичные конечные точки (8)

Change in Supraspinatus Muscle Fiber Length [Срок оценки: Baseline and 6 weeks]
Change in Physiological Cross-Sectional Area of Supraspinatus [Срок оценки: Baseline and 6 weeks]
Change in Pain Intensity (VAS) [Срок оценки: Baseline and 6 weeks]
Change in Shoulder Range of Motion [Срок оценки: Baseline and 6 weeks]
Change in Shoulder Muscle Strength [Срок оценки: Baseline and 6 weeks]
Change in Functional Status (DASH Scores) [Срок оценки: Baseline and 6 weeks]
Change in Functional Status (SPADI Scores) [Срок оценки: Baseline and 6 weeks]
Change in Kinesiophobia (Tampa Scale) [Срок оценки: Baseline and 6 weeks]

Критерии участия

Критерии включения

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