- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07744165
Muscle Thickness, Trunk Proprioception, and Postural Stability in Rotator Cuff Pathology
Evaluation of the Relationship Between Latissimus Dorsi and Abdominal Muscle Thickness, Trunk Proprioception, and Postural Stability in Patients With Rotator Cuff Pathology
The rotator cuff consists of the supraspinatus, infraspinatus, teres minor, and subscapularis muscles and their tendons, which surround and stabilize the shoulder joint. Rotator cuff-related disorders may cause pain, particularly during arm elevation and external rotation, and may limit shoulder movement and daily function.
Shoulder function depends not only on the muscles surrounding the shoulder but also on the coordinated transfer of force through the trunk and extremities, known as the kinetic chain. Impairments in trunk muscle function, core stability, proprioception, and balance may therefore negatively affect shoulder mechanics.
This study aims to investigate the relationships between latissimus dorsi and abdominal muscle thickness, trunk proprioception, and postural stability in individuals with rotator cuff pathology. The study will also examine whether these measurements differ between individuals with rotator cuff pathology and healthy participants.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The rotator cuff consists of the supraspinatus, infraspinatus, teres minor, and subscapularis muscles and their tendons and surrounds the shoulder joint. Rotator cuff syndrome includes various conditions affecting the rotator cuff, such as subacromial impingement syndrome, bursitis, tendinitis, and partial- or full-thickness rotator cuff tears. Rotator cuff-related shoulder pain generally refers to a painful clinical condition that occurs during shoulder elevation and external rotation and is accompanied by limitations in shoulder movement and function. Its etiology is multifactorial. The combination of extrinsic mechanical compression, such as narrowing of the subacromial space, and tendon overuse, such as repetitive overhead activities, has been identified as one of the main mechanisms underlying rotator cuff pathology. Diagnosis is based on medical history, physical examination, and imaging when necessary.
Sequential physiological muscle activations in the upper and lower extremities create an integrated biomechanical task. This sequential organization is referred to as the kinetic chain. During activities predominantly involving the upper extremity, energy is generated and transferred from the proximal to the distal segments. A disruption within the kinetic chain may result in dysfunctional biomechanical outcomes and contribute to the development of pain and injury. Impairments in the proximal components of the kinetic chain may negatively affect shoulder function. Therefore, in patients with shoulder disorders, all components that may impair kinetic chain function should be evaluated.
Core stability is defined as the ability to control the position and movement of the trunk over the pelvis in order to enable optimal force generation and the transfer and control of force and movement to the distal segment during activity. Core muscle activity provides both stability and movement. This mechanism enables proximal stability for distal mobility, the sequential transfer of force from proximal to distal segments, and the generation of intersegmental moments that move and protect the distal joints. The core region is important for providing local strength and balance. It is also positioned at the center of almost all kinetic chains involved in sporting activities. Therefore, adequate core muscle strength facilitates effective control of balance and movement and supports the optimal functioning of kinetic chains associated with both upper- and lower-extremity activities.
The sensorimotor system includes all sensory and motor components involved in maintaining joint stability, together with their central integration and processing mechanisms. This system consists of several components, including proprioception, joint position sense, kinesthesia, force sense, and neuromuscular control. When a shoulder injury occurs, not only mechanical structures such as the joint capsule and glenoid labrum may be affected, but the sensorimotor system may also be impaired. Shoulder injuries may be accompanied by deficits in both proprioception and neuromuscular control, which may consequently result in balance impairments.
Some studies have suggested that pain may also contribute to balance impairment. A possible explanation is that pain-processing mechanisms, the neuronal networks responsible for balance control, and pain-related muscle inhibition partly involve shared pathways within the central nervous system. A recent study conducted in Türkiye that investigated balance in patients with shoulder pain reported a significant difference in balance between the patient and control groups. The study also found that balance impairment was positively associated with pain severity.
This study aims to investigate the relationships between latissimus dorsi and abdominal muscle thickness, trunk proprioception, and postural stability in individuals with rotator cuff pathology. The study will also examine whether these measurements differ between individuals with rotator cuff pathology and healthy participants.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bade Özkan, MD
- Número de teléfono: +905346738855
- Correo electrónico: badeozkann@gmail.com
Ubicaciones de estudio
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Kadıköy
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Istanbul, Kadıköy, Turquía (Türkiye), 34722
- Reclutamiento
- Göztepe Prof. Dr. Süleyman Yalçın City Hospital
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Contacto:
- Bade Özkan, M.D.
- Número de teléfono: +905346738855
- Correo electrónico: badeozkann@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Rotator Cuff Pathology Group
- Willing to participate in the study and able to provide written informed consent
- Aged 18 years or older
- Unilateral shoulder pain lasting for at least 3 months
- Right-hand dominance
- Diagnosis of rotator cuff pathology
Healthy Control Group
- Willing to participate in the study and able to provide written informed consent
- Aged 18 years or older
- Right-hand dominance
- No current shoulder pain
Exclusion Criteria:
- Unwilling or unable to provide written informed consent
- Younger than 18 years
- History of a chronic orthopedic or neurological condition that may affect shoulder, abdominal, or periscapular muscle function
- History of injury or surgery involving the abdominal region
- Bilateral shoulder pain or bilateral shoulder pathology
- Chronic low back pain
- Recent history of lumbar spine injury or surgery
- Presence of a comorbid condition that may cause balance impairment
- History of neuromuscular disease
- History of malignancy
- Pregnancy
- Receipt of physical therapy or rehabilitation for the shoulder region within the previous 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Rotator Cuff Pathology Group
Adults with unilateral shoulder pain lasting at least 3 months and magnetic resonance imaging-confirmed rotator cuff pathology.
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Healthy Control Group
Healthy adults without shoulder pain or a known history of rotator cuff pathology.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Abdominal Muscle Thicknesses
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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The thicknesses of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles will be measured separately in millimeters using diagnostic ultrasonography.
Participants will be assessed in the supine position with a pillow placed under the knees.
Lateral abdominal muscle measurements will be performed at the midpoint of a line drawn between the anterior superior iliac spine and the inferior border of the lowest rib at the midaxillary line.
Rectus abdominis thickness will be measured immediately above the umbilicus at the thickest visible region of the muscle.
Minimal transducer pressure will be applied to avoid compression of the muscle tissue.
Each measurement will be repeated three times, and the mean of the three measurements will be used in the analysis.
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During the single assessment visit at enrollment (Day 1)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Latissimus Dorsi Muscle Thickness
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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Latissimus dorsi muscle thickness will be measured with participants in the prone position, with both upper extremities relaxed and positioned alongside the body and the trunk maintained in a neutral position.
The measurement site will be identified at the level of the 10th rib along a line drawn between the midpoint of the axilla and a point located 2 cm medial to the posterior superior iliac spine.
The ultrasound transducer will be positioned perpendicular to the 10th rib at this level, and latissimus dorsi muscle thickness will be measured at this site.
Minimal transducer pressure will be applied to avoid compression of the muscle tissue.
Each measurement will be repeated three times, and the mean of the three measurements will be used in the analysis.
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During the single assessment visit at enrollment (Day 1)
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Static Postural Stability
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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Static postural stability will be assessed using a pedobarographic platform.
Participants will stand on the platform under standardized testing conditions, and postural sway parameters recorded by the system will be used to evaluate static balance.
Higher postural sway values indicate poorer static postural stability.
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During the single assessment visit at enrollment (Day 1)
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Trunk Proprioception
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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Trunk proprioception will be assessed using a digital inclinometer and the active repositioning method.
Participants will sit at the edge of a bed with the feet supported, hips and knees flexed to 90°, and the pelvis stabilized.
The inclinometer will be positioned over the T4 spinous process.
After three practice trials, participants will perform 30° trunk flexion with their eyes open and maintain the target position for 5 seconds.
They will then return to the target position with their eyes closed.
The absolute difference between the target and reproduced angles will be recorded in degrees.
Three measurements will be performed, and the mean repositioning error will be used in the analysis.
Higher values indicate poorer trunk proprioception.
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During the single assessment visit at enrollment (Day 1)
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Timed Up and Go Test (TUG)
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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Functional mobility will be assessed using the Timed Up and Go Test.
Participants will be instructed to rise from a chair, walk a distance of 3 meters at a comfortable pace, turn, walk back to the chair, and sit down.
The time required to complete the test will be recorded in seconds.
A longer completion time indicates poorer functional mobility.
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During the single assessment visit at enrollment (Day 1)
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Walking Speed
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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Walking speed will be assessed during a standardized walking test and calculated in meters per second by dividing the walking distance by the time required to complete the test.
A higher value indicates a faster walking speed.
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During the single assessment visit at enrollment (Day 1)
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Abdominal Flexion and Lateral Flexion Muscle Strength
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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Abdominal flexion and lateral flexion muscle strength will be assessed using standardized manual muscle testing procedures.
Muscle strength will be graded on an ordinal scale from 0 to 5, where 0 indicates no visible or palpable muscle contraction and 5 indicates the ability to complete the movement against full manual resistance.
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During the single assessment visit at enrollment (Day 1)
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Flexor Endurance Test
Periodo de tiempo: During the single assessment visit at enrollment (Day 1)
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Trunk flexor endurance will be assessed using the flexor endurance test.
Participants will sit with the trunk supported at approximately 60°, the hips and knees flexed to 90°, and the arms crossed over the chest.
The support will then be moved approximately 10 cm backward, and participants will be instructed to maintain the position for as long as possible.
The test will end when the trunk falls below the 60° position.
The duration will be recorded in seconds, with shorter times indicating lower trunk flexor endurance.
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During the single assessment visit at enrollment (Day 1)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC TRUNK BALANCE 2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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