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

5 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

63

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Turchia (Türkiye)
    • Kırşehir
      • Kırşehir, Kırşehir, Turchia (Türkiye), 40100
        • Reclutamento
        • Kırşehir Ahi Evran University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Intensity
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Upper Extremity Function
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Izmir Katip Celebi University

Collaboratori

Kirsehir Ahi Evran Universitesi

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 dicembre 2025

Completamento primario (Stimato)

2 settembre 2026

Completamento dello studio (Stimato)

2 settembre 2026

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2520

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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