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Scapulothoracic Stabilization and Postural Training in Upper Extremity Lymphedema

10 de julho de 2026 atualizado por: Idil Esin Unlu, Toros University

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

This single-center randomized controlled trial aims to investigate the effects 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 assigned to receive either standard lymphedema care alone or standard care combined with scapulothoracic stabilization and postural training. Outcomes including scapular muscle strength, posture, upper extremity function, limb volume, and neck awareness will be assessed at baseline, immediately after treatment, and at a 2-month follow-up. The findings are expected to provide evidence regarding the effectiveness of incorporating targeted stabilization and postural exercises into conventional lymphedema rehabilitation.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: İdil Esin Ünlü, Assist. Prof. Dr.
  • Número de telefone: +90 506 515 66 22
  • E-mail: idil.unlu@toros.edu.tr

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
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.
Comparador Ativo: 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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Upper Extremity Function
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment
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.
Baseline, immediately after completion of treatment, and 2 months after treatment
Change in Head Anterior Translation
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment
Head anterior translation will be assessed using the PostureScreen mobile application.
Baseline, immediately after completion of treatment, and 2 months after treatment
Change in Shoulder Height Asymmetry
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment.
Shoulder height asymmetry will be assessed using the PostureScreen mobile application.
Baseline, immediately after completion of treatment, and 2 months after treatment.
Change in Shoulder Anterior Translation
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment.
Shoulder anterior translation will be assessed using the PostureScreen mobile application.
Baseline, immediately after completion of treatment, and 2 months after treatment.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Scapular Muscle Strength
Prazo: Baseline, immediately after completion of treatment, and 2 months after treatment
Scapular muscle strength (upper, middle, and lower trapezius muscles) will be measured using a handheld dynamometer (MicroFET2) with the isometric make-test method.
Baseline, immediately after completion of treatment, and 2 months after treatment

Colaboradores e Investigadores

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Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de março de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de julho de 2026

Primeira postagem (Real)

13 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 25.02.2026-1214/23

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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