- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Muharrem Gökhan Beydağı, PhD
- Numer telefonu: +905323581105
- E-mail: mgbeydagi@firat.edu.tr
Lokalizacje studiów
-
-
MErkez
-
Elâzığ, MErkez, Turcja (Türkiye), 23200
- Rekrutacyjny
- Firat University
-
Kontakt:
- Muharrem Gökhan Beydağı, PhD
- Numer telefonu: 05323581105
- E-mail: mgbeydagi@firat.edu.tr
-
Kontakt:
- Muhammet Şahin Elbastı, MD
-
Główny śledczy:
- Muhammet Şahin Elbastı, MD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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.
|
|
Aktywny komparator: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Supraspinatus Muscle Pennation Angle
Ramy czasowe: Baseline and 6 weeks
|
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:
|
Baseline and 6 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Supraspinatus Muscle Fiber Length
Ramy czasowe: Baseline and 6 weeks
|
Measured using B-mode ultrasonography at baseline and after 6 weeks. Supraspinatus Fascicle Length:
|
Baseline and 6 weeks
|
|
Change in Physiological Cross-Sectional Area of Supraspinatus
Ramy czasowe: Baseline and 6 weeks
|
Measured via ultrasound imaging at baseline and after 6 weeks. Physiological Cross-Sectional Area (PCSA):
|
Baseline and 6 weeks
|
|
Change in Pain Intensity (VAS)
Ramy czasowe: Baseline and 6 weeks
|
Pain intensity will be assessed using the Visual Analog Scale (0-10 cm). Visual Analog Scale for Pain:
|
Baseline and 6 weeks
|
|
Change in Shoulder Range of Motion
Ramy czasowe: Baseline and 6 weeks
|
Measured using a goniometer for flexion, abduction, internal and external rotation. Shoulder Range of Motion:
|
Baseline and 6 weeks
|
|
Change in Shoulder Muscle Strength
Ramy czasowe: Baseline and 6 weeks
|
Measured using a hand-held dynamometer during isometric contraction. Shoulder Muscle Strength
|
Baseline and 6 weeks
|
|
Change in Functional Status (DASH Scores)
Ramy czasowe: Baseline and 6 weeks
|
Functional status will be assessed using DASH questionnaires. Disabilities of the Arm, Shoulder and Hand (DASH) Score
|
Baseline and 6 weeks
|
|
Change in Functional Status (SPADI Scores)
Ramy czasowe: Baseline and 6 weeks
|
Functional status will be assessed using SPADI questionnaires. Shoulder Pain and Disability Index (SPADI):
|
Baseline and 6 weeks
|
|
Change in Kinesiophobia (Tampa Scale)
Ramy czasowe: Baseline and 6 weeks
|
Measured using the Tampa Scale of Kinesiophobia. Tampa Scale for Kinesiophobia:
|
Baseline and 6 weeks
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FU_MGBeydagi_RC_B_2026/05
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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