Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Early Mobilization Following Arthroscopic Rotator Cuff Repair

13 de outubro de 2021 atualizado por: University of Alberta

Early Mobilization Following Arthroscopic Rotator Cuff Repair: a Randomized Controlled Trial

Shoulder rotator cuff (RC) tears are a significant cause of pain and disability. Surgery is done to reconnect the torn RC tendon(s) to the bone. The goals of RC surgery are to decrease pain, and to increase range of motion (ROM) and strength. This is done arthroscopically; through a small incision in the patient's shoulder. After surgery, patients are usually placed in a sling for up to 6 weeks to protect the repaired shoulder tendons. During this time, ROM exercises are only done by using the un-operated arm for assistance. Voluntary or active shoulder movement is usually not permitted to allow the repaired tendons to heal. Unfortunately, some patients develop shoulder stiffness while wearing the sling, which can delay rehabilitation. Any delays in rehabilitation may result in reduced shoulder function, a slower return-to-work or daily activities, and may also impact the health care system, through increased use and cost of rehabilitation.

This study's purpose is to determine if patients can safely stop wearing their sling as early as pain and comfort allow following RC surgery. A total of 200 patients (100 per group) will be randomly assigned to one of two study groups:

Patients in Group A (accelerated rehab) will wear their sling for comfort only following surgery. Self-assisted ROM exercises are allowed at any time. This means that patients may stop wearing their sling if pain and comfort allow, and start active movement for activities of daily living only.

Patients in Group B (standard rehab) will wear their sling for 6 weeks. Like in group A, self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in both groups will be given the same self-assisted ROM exercises after surgery.

Patients who agree to participate in the study will see their surgeon and the study physical therapist/research coordinator on 6 occasions (pre-surgery, 2 weeks, 6 weeks, 3, 6, 12 months post-surgery). Each visit will take about 30 minutes and will include a ROM assessment, strength assessment (as appropriate) and disease-specific quality of life questionnaires. Patients will also undergo an Ultrasound exam to verify that their RC repair is intact at 12-months. Differences in ROM, strength, questionnaire scores, RC integrity, and adverse events will be examined between the two groups. Differences will also be examined according to RC tear size and patient characteristics.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

211

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

  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 2H9
        • Glen Sather Sports Medicine clinic

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 a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Patient is over 18 years of age
  2. Patient has attempted non-operative treatment (i.e. physical therapy consisting of progressive ROM, strengthening, and postural exercises)
  3. Patient has a full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)

Exclusion Criteria:

  1. Patient has a full-thickness tear of the subscapularis and/or teres minor
  2. Patient has undergone previous RC surgery to the affected shoulder
  3. Patient has major joint trauma, infection, or avascular necrosis
  4. Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
  5. Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
  6. Patient has a psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
  7. Patient has a major medical illness where life expectancy is less than 2 years
  8. Patient does not speak/read/understand English
  9. Patient has no fixed address or means of contact
  10. Surgeon or patient has decided to cancel surgery
  11. Surgeon concludes that an arthroscopic repair is not appropriate at time of surgery (based on RC tear characteristics or concomitant shoulder pathology)
  12. Patient unwilling to complete necessary follow-ups

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: Group A (early ROM)
Group A (early ROM) will use the sling for comfort only
Procedimento: No Sling
Early range of motion
Comparador Ativo: Group B (usual care)
Group B (usual care) will be immobilized in a sling for 6 weeks.
Procedimento: Sling
Patients will use the sling for 6 weeks, as per usual care

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Western Ontario Rotator Cuff Index (WORC)
Prazo: Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
a 5-part (physical symptoms, sports/recreation, work, lifestyle, emotions) 21-item disease specific questionnaire. Measured in percentage. 0% = worst, 100 % = best
Baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Range of Motion (ROM)
Prazo: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Measured flexion, abduction, external rotation in 90 degrees abduction [ER(90)], internal rotation in 90 degrees abduction [IR(90)], horizontal adduction, scaption, degrees with a goniometer by the same tester throughout
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Strength
Prazo: Baseline, 6 months, 12 months, 24 months
strength was measured in pounds of force using a dynamometer (microFET3, Hoggan Health Industries, West Jordan, UT). Isometric shoulder flexion, abduction, were measured with the arm in neutral abduction and elbow at 90 degrees flexion. External and internal rotation were measured in 90 degrees of abduction. Peak values were recorded during each contraction which was held for 3 seconds. Values were expressed as raw values.
Baseline, 6 months, 12 months, 24 months
The Short Form (36) Health Survey
Prazo: baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
The Short Form (36) Health Survey is a quality of life questionnaire that looks at eight scales: physical functioning, Role-physical, bodily pain, general health, vitality, social function, role-emotional, mental health. Each scale ranges between 0 (completely disable) to 100 (completely able).
baseline, 6 weeks, 3 months, 6 months, 12 months and 24 months
Adverse Events
Prazo: 2 weeks, 6 weeks, 3 months, 6months

The following complications were monitored throughout study:

  • Medical related: urinary, gastrointestinal, cardiac, pulmonary, metabolic
  • Surgical related: nerve injury, superficial or deep infection, dislocation, frozen shoulder, hematoma, biceps rupture, failure of tendon healing, dermatitis, reflex sympathetic dystrophy (RSD), persistent pain, re-injury.
  • Other

The surgeon responsible for the patient used clinical judgment to make a decision regarding if the complication was related or not to the treatment being tested (use or not of sling).
2 weeks, 6 weeks, 3 months, 6months
Pain in the Shoulder at Baseline, 6 Weeks, 3, 6, 12, 24 Months
Prazo: baseline, 6 weeks, 3, 6, 12, 24 months
Shoulder pain at rest, with activity and at night were measured using a visual analogue scale of 0-10 (no pain to severe pain)
baseline, 6 weeks, 3, 6, 12, 24 months

Colaboradores e Investigadores

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

Patrocinador

University of Alberta

Investigadores

  • Investigador principal: David Sheps, MD,MSc,FRCSC, University of Alberta

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

1 de abril de 2011

Conclusão Primária (Real)

1 de abril de 2015

Conclusão do estudo (Real)

2 de maio de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

8 de abril de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de abril de 2011

Primeira postagem (Estimativa)

12 de abril de 2011

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de outubro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de outubro de 2021

Última verificação

1 de outubro de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RES0005824

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 .

Se inscrever