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Recruiting NCT07568340

Comparison of Supervised Rehabilitation and Home Exercise Programs in Subacromial Impingement Syndrome

No phase Interventional Subacromial Impingement Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supervised Rehabilitation Program, Home Exercise Program.
Who it may be relevant to
Registry conditions: Subacromial Impingement Syndrome. Basic parameters: 30 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Pain Intensity [Time frame: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)]
Secondary outcome measures (5)
  • Upper Extremity Function [Time frame: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)]
  • Shoulder Range of Motion [Time frame: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)]
  • Grip Strength [Time frame: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)]
  • Sleep Quality [Time frame: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)]
  • Quality of Life-WHOQOL-BREF [Time frame: Baseline (Day 0, prior to intervention) and Week 4 (end of intervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Kırsehir Ahi Evran University — Kırşehir

Publications

  • 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. PMID 31726386
  • 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. PMID 24847788
  • 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. PMID 37003655

Identifiers

NCT: NCT07568340 · 2520

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗