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Myofascial Versus Conventional Physiotherapy (MYONAMASTE)

31 de agosto de 2020 atualizado por: The Greater Poland Cancer Centre

Myofascial Versus Conventional Physiotherapy in Post-mastectomy Patients: a Randomized Controlled Trial

A total of 61 patients who underwent total mastectomy for breast cancer with axillar lymph dissection and adjuvant radiotherapy were enrolled in this trial.

The patients were randomized by toss of a coin to the treatment (n=30) or control (n=26) groups; of these, 48 met all study protocol requirements, including the final assessment. Inclusion criteria were: presence of functional difficulties in the shoulder area and/or upper torso on the surgical side, and 2) eligibility for physiotherapy (determined by the treating physician). Patients with recurrent disease and/or inflammatory or acute ailments were excluded. All patients gave their informed consent to participate in the study.

The treatment group received myofascial treatment while patients in the control group received conventional therapy consisting of exercise and massage.

Visão geral do estudo

Descrição detalhada

Treatment duration in both groups was a mean of 4 weeks. Therapy was performed daily excluding weekends and consisted of 45 minutes of individual work with an oncological physiotherapist. In the treatment group, manual myofascial techniques were used to decrease muscle tension and increase elasticity of the soft tissues in the surgical area as well as in tissues that could affect range of motion (ROM) and cause pain. Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side. The exact sequence and number of procedures differed in each patient according to need as determined by prior functional examination. The control group underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area. Both groups before or after every of the treatment procedure underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.

Patient interviews and diagnostic examinations were performed at baseline (pre-treatment) and after treatment finalization. The following variables were assessed during the diagnostic examination of the muscle length with Janda's protocol:

Pectoralis Major - pars clavicularis - the normal length of these fibers allows the patient's arm (in an extended position close to the body) to rest below the horizontal.

Pectoralis Major - pars sternocostalis - the normal length of these fibers allows the abducted the patient's arm to 90° to rest below the horizontal.

Pectoralis Major - pars abdomen - the normal length of these pectoral fibers allows the abducted the patient's arm to 150° with slight external rotation to rest in a horizontal position.

Latissimus dorsi - the normal length allows the arm to rest horizontally to the table with the lumbar spine flat on the table.

Descending part of trapezius - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.

Levator scapulae - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.

Tipo de estudo

Intervencional

Inscrição (Real)

61

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.

Locais de estudo

    • Wielkopolska
      • Poznań, Wielkopolska, Polônia, 61-866
        • Greater Poland Cancer Centre

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • presence of functional difficulties in the shoulder area and/or upper torso on the surgical side
  • eligibility for physiotherapy (determined by the treating physician)
  • signed informed consent to participate in the study.

Exclusion Criteria:

  • patients with recurrent disease and/or inflammatory or acute ailments were excluded.

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: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: TREATMENT GROUP
Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side. The exact sequence and number of procedures differed in each patient according to need as determined by prior functional examination. Before or after every of the treatment procedure treatment group patients underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.
Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side.
Outro: CONTROL GROUP
Treatment duration was a mean of 4 weeks. Therapy was performed daily excluding weekends and consisted of 45 minutes of individual work with an oncological physiotherapist. The control group underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area. Before or after every of the treatment procedure control group patients underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.
Underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
muscle length
Prazo: 2 years

muscle length with Janda's protocol

Pectoralis Major - pars clavicularis - the normal length of these fibers allows the patient's arm (in an extended position close to the body) to rest below the horizontal.

Pectoralis Major - pars sternocostalis - the normal length of these fibers allows the abducted the patient's arm to 90° to rest below the horizontal.

Pectoralis Major - pars abdomen - the normal length of these pectoral fibers allows the abducted the patient's arm to 150° with slight external rotation to rest in a horizontal position.

Latissimus dorsi - the normal length allows the arm to rest horizontally to the table with the lumbar spine flat on the table.

Descending part of trapezius - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.

Levator scapulae - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt [Page et al. 2010].

2 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Active ROM in the shoulder joint on the surgical side
Prazo: 2 years
complete pathological response (pCR, pathologic Complete Response)
2 years
pathological response
Prazo: 2 years
ROM of the shoulder joint on the surgical side (flexion; extension; abduction; internal rotation; external rotation in horizontal flexion
2 years
Pain intensity
Prazo: 2 years
VAS - A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain imaginable (10) . A patient marks a point ( 0 to 10) on the line that matches the amount of pain she feels."
2 years
Scar mobility
Prazo: 2 years
Made by the centimeter measure as difference of distance from the bone point, to the most limited place in the scar. It was measured in directions: cranial (distance from the ridge of the coracoid) and in the transverse direction (the distance from the xiphoidal process). The centimeter measure was the distance from the bone point (xiphoid process and coracoid), to the most limited place in the scar (which was marked on the patient's examination card so that the measurement could be repeated to the same place
2 years
Presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome
Prazo: 2 years
Was observed presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome
2 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Sławomir Marszałek, PhD, Greater Poland Cancer Centre

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 janeiro de 2013

Conclusão Primária (Real)

31 de dezembro de 2014

Conclusão do estudo (Real)

31 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de abril de 2020

Primeira postagem (Real)

30 de abril de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de setembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2020

Última verificação

1 de abril de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • MYONAMASTE

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

produto fabricado e exportado dos EUA

Não

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Ensaios clínicos em Terapia

Ensaios clínicos em manual myofascial techniques

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