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- Ensayo clínico NCT07697495
Scapulothoracic Stabilization and Postural Training in Upper Extremity Lymphedema
Effects of Scapulothoracic Stabilization and Postural Training Added to Standard Lymphedema Care on Muscle Strength, Posture and Functional Outcomes in Secondary Upper Extremity Lymphedema: A Single-Center Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Secondary upper extremity lymphedema is a common complication following breast cancer treatment and is characterized by chronic swelling, pain, reduced muscle strength, impaired upper extremity function, and postural alterations. These impairments may negatively affect daily activities, body perception, and quality of life. Although Complex Decongestive Therapy (CDT) is considered the gold standard for lymphedema management, conventional treatment primarily focuses on edema reduction and does not specifically address scapular stability, postural alignment, or neuromuscular control.
Altered scapulothoracic biomechanics and postural dysfunction are frequently observed in individuals with breast cancer-related lymphedema. These impairments may contribute to shoulder dysfunction, muscle weakness, compensatory movement patterns, and persistent functional limitations. Scapulothoracic stabilization exercises aim to restore scapular muscle balance and improve dynamic shoulder stability, whereas postural training promotes optimal alignment and body awareness. The combined application of these interventions may enhance functional recovery beyond the effects of standard CDT alone; however, evidence from randomized controlled trials remains limited.
This single-center, prospective, randomized controlled trial aims to evaluate the effectiveness of adding scapulothoracic stabilization and postural training to standard lymphedema care in women with secondary upper extremity lymphedema following breast cancer surgery. Participants will be randomly allocated to either a control group receiving standard lymphedema care or an intervention group receiving standard care plus scapulothoracic stabilization and postural training. Randomization will be performed using a computer-generated allocation sequence, and all outcome assessments will be conducted by a blinded assessor.
Outcome measures will be collected at baseline, immediately after completion of treatment, and at a 2-month follow-up. Primary and secondary outcomes will include scapular muscle strength measured with a handheld dynamometer (MicroFET2), postural alignment assessed using the PostureScreen application, upper extremity function evaluated with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, limb volume calculated from serial circumference measurements, and neck awareness assessed using the Fremantle Neck Awareness Questionnaire (FreNAQ). The findings of this study are expected to provide evidence regarding the clinical benefits of incorporating targeted scapulothoracic stabilization and postural training into conventional lymphedema rehabilitation and may contribute to the development of more comprehensive rehabilitation protocols for breast cancer survivors.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: İdil Esin Ünlü, Assist. Prof. Dr.
- Número de teléfono: +90 506 515 66 22
- Correo electrónico: idil.unlu@toros.edu.tr
Ubicaciones de estudio
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Adana, Turquía (Türkiye)
- Reclutamiento
- Adana Şehir Eğitim ve Araştırma Hastanesi
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Contacto:
- Deniz TUNCA, PT
- Número de teléfono: +90 532 409 36 33
- Correo electrónico: denizcanoglu82@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Female patients aged 18 to 65 years.
- Diagnosed with secondary upper extremity lymphedema following breast cancer surgery (mastectomy).
- Willing to participate in the study.
- Able to provide written informed consent.
Exclusion Criteria:
- Active infection (e.g., cellulitis or lymphangitis).
- Advanced shoulder or cervical pathology.
- Neurological disorders affecting upper extremity function.
- Metastatic disease.
- Receiving active chemotherapy.
- Participation in another intensive lymphedema rehabilitation program within the previous 3 months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Scapulothoracic Stabilization
Participants assigned to the experimental group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises, together with a structured scapulothoracic stabilization and postural training program.
The additional exercise program is designed to improve scapular muscle function, postural alignment, and upper extremity function.
Assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
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Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
A supervised exercise program consisting of scapulothoracic stabilization exercises and postural training designed to improve scapular muscle strength, postural alignment, and upper extremity function.
The program will be provided in addition to standard Complex Decongestive Therapy throughout the treatment period.
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Comparador activo: Control
Participants assigned to the control group will receive standard Complex Decongestive Therapy (CDT), including manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises according to routine clinical practice.
Outcome assessments will be performed at baseline, immediately after treatment, and at a 2-month follow-up.
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Standard Complex Decongestive Therapy consisting of manual lymphatic drainage, compression therapy, skin care, and therapeutic exercises.
Treatment will be delivered according to established clinical guidelines and routine lymphedema rehabilitation protocols.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Upper Extremity Function
Periodo de tiempo: Baseline, immediately after completion of treatment, and 2 months after treatment
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Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire.
The DASH is a validated 30-item patient-reported outcome measure evaluating symptoms and functional limitations of the upper extremity.
Scores range from 0 to 100, with higher scores indicating greater disability.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Change in Head Anterior Translation
Periodo de tiempo: Baseline, immediately after completion of treatment, and 2 months after treatment
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Head anterior translation will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Change in Shoulder Height Asymmetry
Periodo de tiempo: Baseline, immediately after completion of treatment, and 2 months after treatment.
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Shoulder height asymmetry will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment.
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Change in Shoulder Anterior Translation
Periodo de tiempo: Baseline, immediately after completion of treatment, and 2 months after treatment.
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Shoulder anterior translation will be assessed using the PostureScreen mobile application.
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Baseline, immediately after completion of treatment, and 2 months after treatment.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Scapular Muscle Strength
Periodo de tiempo: Baseline, immediately after completion of treatment, and 2 months after treatment
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Scapular muscle strength (upper, middle, and lower trapezius muscles) will be measured using a handheld dynamometer (MicroFET2) with the isometric make-test method.
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Baseline, immediately after completion of treatment, and 2 months after treatment
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- 25.02.2026-1214/23
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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