- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07568340
Comparison of Supervised Rehabilitation and Home Exercise Programs in Subacromial Impingement Syndrome (SAIS-REHAB)
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Kırşehir
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Kırşehir, Kırşehir, Törökország (Türkiye), 40100
- Toborzás
- Kırşehir Ahi Evran University
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Kapcsolatba lépni:
- Atahan Turhan, PhD
- Telefonszám: 90 386 280 40 81 - 4107 - 4070
- E-mail: atahanturhan@hotmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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.
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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.
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Kísérleti: 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.
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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.
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Nincs beavatkozás: 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.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Pain Intensity
Időkeret: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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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.
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Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Upper Extremity Function
Időkeret: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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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.
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Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Shoulder Range of Motion
Időkeret: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Shoulder flexion, extension, abduction, internal rotation, and external rotation range of motion will be measured using a universal goniometer.
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Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Grip Strength
Időkeret: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Grip strength of the affected upper extremity will be assessed using a hand dynamometer.
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Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Sleep Quality
Időkeret: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Sleep quality will be assessed using the Single-Item Sleep Quality Scale (0-10).
Higher scores indicate poorer sleep quality.
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Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Quality of Life-WHOQOL-BREF
Időkeret: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Quality of life will be assessed using the WHOQOL-BREF questionnaire.
Higher scores indicate better quality of life
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Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)
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Együttműködők és nyomozók
Szponzor
Együttműködők
Publikációk és hasznos linkek
Általános kiadványok
- Gutierrez-Espinoza H, Araya-Quintanilla F, Cereceda-Muriel C, Alvarez-Bueno C, Martinez-Vizcaino V, Cavero-Redondo I. Effect of supervised physiotherapy versus home exercise program in patients with subacromial impingement syndrome: A systematic review and meta-analysis. Phys Ther Sport. 2020 Jan;41:34-42. doi: 10.1016/j.ptsp.2019.11.003. Epub 2019 Nov 6.
- Diercks R, Bron C, Dorrestijn O, Meskers C, Naber R, de Ruiter T, Willems J, Winters J, van der Woude HJ; Dutch Orthopaedic Association. Guideline for diagnosis and treatment of subacromial pain syndrome: a multidisciplinary review by the Dutch Orthopaedic Association. Acta Orthop. 2014 Jun;85(3):314-22. doi: 10.3109/17453674.2014.920991. Epub 2014 May 21.
- Horowitz EH, Aibinder WR. Shoulder Impingement Syndrome. Phys Med Rehabil Clin N Am. 2023 May;34(2):311-334. doi: 10.1016/j.pmr.2022.12.001. Epub 2023 Feb 26.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2520
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
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-
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