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

5 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

63

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Turquie (Türkiye)
    • Kırşehir
      • Kırşehir, Kırşehir, Turquie (Türkiye), 40100
        • Recrutement
        • Kırşehir Ahi Evran University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Supervised Rehabilitation Program
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.
Expérimental: 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.
Comportemental: Home Exercise Program
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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain Intensity
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Upper Extremity Function
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Izmir Katip Celebi University

Collaborateurs

Kirsehir Ahi Evran Universitesi

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

2 décembre 2025

Achèvement primaire (Estimé)

2 septembre 2026

Achèvement de l'étude (Estimé)

2 septembre 2026

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

28 avril 2026

Première publication (Réel)

5 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2520

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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