Kırsehir Ahi Evran University
Kırşehir, 40100, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07568340
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.
Interested in participating?
Request Info30 year–65 year
All sexes
Interventional
Not applicable
Kırşehir, 40100, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Izmir Katip Celebi University
Other
Comparison of the Effectiveness of a Physiotherapist-Supervised Rehabilitation Program and Home Exercise Education in Subacromial Impingement Syndrome
Acronym: SAIS-REHAB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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