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

Comparison of Supervised Rehabilitation and Home Exercise Programs in Subacromial Impingement Syndrome (SAIS-REHAB)

5 de maio de 2026 atualizado por: Merve Kurt-Aydin, Izmir Katip Celebi University

Comparison of the Effectiveness of a Physiotherapist-Supervised Rehabilitation Program and Home Exercise Education in Subacromial Impingement Syndrome

This randomized controlled trial aims to compare the effectiveness of physiotherapist-supervised rehabilitation and home exercise programs in individuals with subacromial impingement syndrome (SAIS). SAIS is a common musculoskeletal disorder characterized by shoulder pain, reduced range of motion, and functional limitations, negatively affecting quality of life.

Participants diagnosed with SAIS will be randomly assigned to one of three groups: a supervised rehabilitation group, a home exercise group, or a control group. Randomization will be performed using an online randomization tool. Individuals in the supervised rehabilitation group will receive a structured physiotherapy program administered by a physiotherapist, while those in the home exercise group will perform a standardized exercise program at home following initial instruction. Participants in the control group will not receive any intervention during the study period and will be assessed only.

Outcome measures including pain intensity, upper extremity function, range of motion, grip strength, sleep quality, and quality of life will be evaluated at baseline and after the intervention period. The results of this study are expected to provide evidence regarding the comparative effectiveness of supervised and home-based exercise approaches in the management of SAIS.

Visão geral do estudo

Descrição detalhada

Subacromial impingement syndrome (SAIS) is one of the most common causes of shoulder pain, leading to decreased range of motion, muscle weakness, functional limitations, and reduced quality of life. Exercise-based rehabilitation is considered a primary conservative treatment approach. However, access to supervised physiotherapy services may be limited due to long waiting times and healthcare system constraints. Home exercise programs may serve as an alternative, but evidence comparing their effectiveness with supervised rehabilitation remains limited.

This study is designed as a randomized controlled trial to compare the effectiveness of physiotherapist-supervised rehabilitation and home exercise programs in individuals with SAIS. A total of 63 participants who meet the inclusion criteria will be recruited and randomly assigned into three groups: supervised rehabilitation, home exercise, and control.

Randomization will be performed using an online randomization tool. Participants allocated to the supervised rehabilitation group will receive a structured rehabilitation program consisting of pain management modalities, range of motion exercises, strengthening exercises, and functional training under the supervision of a physiotherapist, five days per week for four weeks. The home exercise group will receive a structured exercise program including stretching, strengthening, and mobility exercises after a single training session and will continue the program independently at home. Participants in the control group will not receive any intervention during the study period and will be included in the supervised rehabilitation program after the final assessment.

Outcome measures will include pain intensity assessed by Visual Analog Scale, upper extremity function assessed by the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH), shoulder range of motion measured by goniometer, grip strength measured by dynamometer, sleep quality assessed by a single-item sleep quality scale, and quality of life assessed by the WHOQOL-BREF. Assessments will be conducted at baseline and at the end of the 4-week intervention period.

The findings of this study will contribute to the literature by providing evidence on the comparative effectiveness of supervised rehabilitation and home-based exercise programs and may guide clinical decision-making in the management of SAIS.

Tipo de estudo

Intervencional

Inscrição (Estimado)

63

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

    • Kırşehir
      • Kırşehir, Kırşehir, Turquia (Türkiye), 40100
        • Recrutamento
        • Kırşehir Ahi Evran University
        • Contato:

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

Sim

Descrição

Inclusion Criteria:

  • Voluntary participation in the study
  • Literate in Turkish
  • Aged between 30 and 65 years
  • No visual or hearing impairment
  • Diagnosed with unilateral subacromial impingement syndrome by a specialist physician
  • Positive painful arc test, Infraspinatus test, and Hawkins-Kennedy test
  • Pain during overhead activities

Exclusion Criteria:

  • Presence of a mental or psychological disorder that may affect study findings
  • Inadequate cooperation
  • History of upper extremity fracture within the last 6 months
  • Presence of cervical neurological symptoms
  • Glenohumeral instability
  • Acromioclavicular joint pathology
  • Full-thickness rotator cuff tear or total rupture
  • Signs of glenohumeral osteoarthritis
  • History of frozen shoulder

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: Supervised Rehabilitation
Participants in this group will receive a physiotherapist-supervised rehabilitation program five days per week for four weeks. The program will include pain management approaches, stretching exercises, range of motion exercises, scapular stabilization exercises, strengthening exercises, and activity modification training according to standard physiotherapy procedures.
A physiotherapist-supervised rehabilitation program including pain management approaches, stretching exercises, range of motion exercises, scapular stabilization exercises, strengthening exercises, and activity modification training administered five days per week for four weeks.
Experimental: Home Exercise Program
Participants in this group will receive a structured home exercise program after an education session. The program will include stretching, range of motion, scapular stabilization, and strengthening exercises to be performed independently at home for four weeks.
A structured home exercise program including stretching, range of motion, scapular stabilization, and strengthening exercises performed independently at home for four weeks following an education session.
Sem intervenção: Control
Participants in this group will not receive any intervention during the four-week study period. Baseline and follow-up assessments will be performed. Individuals who are required to wait more than four weeks before starting physiotherapy sessions will be included in this group.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pain Intensity
Prazo: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Pain intensity will be assessed using the Visual Analog Scale (0-10 cm) during rest, activity, and night pain. Higher scores indicate greater pain severity.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Upper Extremity Function
Prazo: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Upper extremity function will be assessed using the Disabilities of the Arm, Shoulder and Hand Questionnaire-Short Form (DASH-SF; 0-100). Higher scores indicate greater disability.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Shoulder Range of Motion
Prazo: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Shoulder flexion, extension, abduction, internal rotation, and external rotation range of motion will be measured using a universal goniometer.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Grip Strength
Prazo: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Grip strength of the affected upper extremity will be assessed using a hand dynamometer.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Sleep Quality
Prazo: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Sleep quality will be assessed using the Single-Item Sleep Quality Scale (0-10). Higher scores indicate poorer sleep quality.
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Quality of Life-WHOQOL-BREF
Prazo: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
Quality of life will be assessed using the WHOQOL-BREF questionnaire. Higher scores indicate better quality of life
Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)

Colaboradores e Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

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)

2 de dezembro de 2025

Conclusão Primária (Estimado)

2 de setembro de 2026

Conclusão do estudo (Estimado)

2 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de abril de 2026

Primeira postagem (Real)

5 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2520

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

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 .

Ensaios clínicos em Síndrome do impacto subacromial

Ensaios clínicos em Supervised Rehabilitation Program

Se inscrever