- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07265765
Effectiveness of Pilates Exercise in Patients With Subacromial Impingement Syndrome
Subacromial Impingement Syndrome(SIS) is considered as one of the most common causes of shoulder pain, can be the source of considerable pain, disability and leads to limitations in activities of daily living.
This study aimed to investigate the effectiveness of the Pilates versus conventional treatment on shoulder pain, function, ROM and muscle strength in patients with SIS.
Study Overview
Status
Intervention / Treatment
Detailed Description
Shoulder pain is the third most common chronic pain among musculoskeletal disorders, following low back pain and knee pain; it is usually characterized as non-traumatic complaints that arise from arm, neck and shoulder regions.
Approximately 50% of those experiencing shoulder pain have symptoms that indicate subacromial impingement syndrome (SIS) diagnosis; the prognosis varies widely; from pain to limited range of motion affecting their daily life activities: with about 40% of individuals suffer from pain one year later after their initial consulting with their primary care clinician.
The SIS is a painful condition that characterized by narrowing of the subacromial space that causes inflammation and degeneration of rotator cuff structures, resulting in pain during arm elevating.
Previous research identified many causes for the impingement such as poor posture, overuse or repetitive trauma, age-related changes, fatigue of the scapular and glenohumeral muscles, biomechanical alterations, neuromuscular adaptations, rotator cuff and deltoid muscle imbalances.
It leads to pain, disability, limited range of motion (ROM), loss of muscle strength, poor quality of life and sleep disturbances. There are many treatment approaches adopted for SIS such as conservative, pharmaceutical and surgical approach in severe cases.
Regarding the conservative it is considered the main treatment of SIS it often includes therapeutic exercises such as scapular stabilization exercises, rotator cuff strengthening exercises, stretching exercises and Pilates exercise that are effective in restoring shoulder function.
Pilates exercise was developed by Joseph Pilates as a comprehensive exercise, emphasizes the connection between mind and body control, making it a valuable tool in rehabilitation for enhancing core muscle strength, endurance, flexibility, posture, ROM, overall health, and quality of life are prevalent for both healthy individuals and rehabilitation purposes for SIS.
Pilates has been shown to effectively reduce shoulder pain, improve ROM, enhance posture, and support functional recovery in individuals with chronic shoulder pain, as highlighted in studies emphasizing its role in core stability and movement control even though it has a favorable impacts, the evidence to demonstrate its effect is limited.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza Governorate
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Cairo, Giza Governorate, Egypt, 11432
- Faculty of Physical Therapy Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female patients aged between 35-65 years old
- Presence of shoulder pain for at least three months
- Painful arc of movement during flexion or abduction or both
- The patient will be diagnosed with SIS if the tests of the Neer, Empty Can, and Hawkins will be positive during the physical examination.
Exclusion Criteria:
- History of any surgical procedure to the affected upper extremity (Heron et al., 2017 and).
- History of trauma, fracture, instability and shoulder dislocation to the shoulder in less than 12 weeks previously (EDA et al., 2016).
- History of presence of cervical symptoms (neck pain, numbness or tingling in the upper extremity) (Heron et al., 2017).
- History of corticosteroid injection in the shoulder region in the last 6 months (Turgut et al., 2017).
- None- cooperative participants or cognitive impairment (a communication problem) (EDA et al., 2016).
- History of any systemic illness, reflex sympathetic dystrophy and related syndromes e.g. rheumatoid arthritis, ankylosing spondylitis, diagnosed by physician (Heron et al., 2017 and Turgut et al., 2017).
- Passive limitation of range of movement, stiff shoulder and less than 90 active elevation (Heron et al., 2017 and EDA et al., 2016).
- Evidence of complete rotator cuff tear (positive drop arm test) (Heron et al., 2017).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: conventional group
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patients received conventional physical therapy exercise program that include (rotator cuff strength exercise, scapular stability exercise and posterior capsule stretch exercise) for 18 sessions for 6 weeks
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Experimental: pilates exercise group
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patients who received the Pilates exercise in form of (shoulder drop, chest opener, book opening, scarecrow, dart, quadruped exercise, spine twist exercise).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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shoulder function
Time Frame: measured at baseline then after 6 weeks
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measured by the Arabic version of the SPADI (Shoulder Pain and Disability Index) is a self-report questionnaire designed to assess shoulder pain and disability in outpatients.
It consists of 13 items: a 5-item pain subscale and an 8 item disability subscale; it is widely used and available in multiple languages such as the Arabic version ;with higher values indicating greater severity.
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measured at baseline then after 6 weeks
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Shoulder Pian
Time Frame: at baseline and after 6 weeks
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measured using Numerical Pain scale It is a self-reported scale where the patient rates their pain on a numerical range, usually from 0 to 10; where the zero indicate less pain and 10 worst pain
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at baseline and after 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
shoulder ROM(abduction and internal rotation)
Time Frame: measured at baseline and after 6 weeks
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measured by Digital goniometer The digital goniometer (DG)is a precise and user-friendly tool for measuring joint ROM in rehabilitation, offering real-time feedback and improved accuracy over the universal goniometer.
It is commonly used for shoulder impingement assessment, helping track progress and ensures safe mobility improvements
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measured at baseline and after 6 weeks
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shoulder muscle strength(UT,MT,LT,SA,ER,IR)
Time Frame: measured at baseline and after 6 weeks
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measured by HHD(Hand Held Dynamometer)(Lafayette) The handheld dynamometer (HHD) (model 01165, Lafayette Instrument Company, Indiana, USA)Is a reliable and objective tool for assessing isometric muscle strength, outperforming manual muscle testing.
Lightweight and portable, it has strong concurrent validity, making it practical for strength evaluation.
It is the preferred method for measuring shoulder rotator strength in symptomatic patients in clinical setting
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measured at baseline and after 6 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
- Chamorro C, Arancibia M, Trigo B, Arias-Poblete L, Jerez-Mayorga D. Absolute Reliability and Concurrent Validity of Hand-Held Dynamometry in Shoulder Rotator Strength Assessment: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Sep 3;18(17):9293. doi: 10.3390/ijerph18179293.
- Alsanawi HA, Alghadir A, Anwer S, Roach KE, Alawaji A. Cross-cultural adaptation and psychometric properties of an Arabic version of the Shoulder Pain and Disability Index. Int J Rehabil Res. 2015 Sep;38(3):270-5. doi: 10.1097/MRR.0000000000000118.
- Nazari G, MacDermid JC, Bryant D, Athwal GS. The effectiveness of surgical vs conservative interventions on pain and function in patients with shoulder impingement syndrome. A systematic review and meta-analysis. PLoS One. 2019 May 29;14(5):e0216961. doi: 10.1371/journal.pone.0216961. eCollection 2019.
- Melo ASC, Moreira JS, Afreixo V, Moreira-Goncalves D, Donato H, Cruz EB, Vilas-Boas JP, Sousa ASP. Effectiveness of specific scapular therapeutic exercises in patients with shoulder pain: a systematic review with meta-analysis. JSES Rev Rep Tech. 2024 Jan 19;4(2):161-174. doi: 10.1016/j.xrrt.2023.12.006. eCollection 2024 May.
- Lee SM, Lee CH, O'Sullivan D, Jung JH, Park JJ. Clinical effectiveness of a Pilates treatment for forward head posture. J Phys Ther Sci. 2016 Jul;28(7):2009-13. doi: 10.1589/jpts.28.2009. Epub 2016 Jul 29.
- Desmeules F, Roy JS, Lafrance S, Charron M, Dube MO, Dupuis F, Beneciuk JM, Grimes J, Kim HM, Lamontagne M, McCreesh K, Shanley E, Vukobrat T, Michener LA. Rotator Cuff Tendinopathy Diagnosis, Nonsurgical Medical Care, and Rehabilitation: A Clinical Practice Guideline. J Orthop Sports Phys Ther. 2025 Apr;55(4):235-274. doi: 10.2519/jospt.2025.13182.
- Byrnes K, Wu PJ, Whillier S. Is Pilates an effective rehabilitation tool? A systematic review. J Bodyw Mov Ther. 2018 Jan;22(1):192-202. doi: 10.1016/j.jbmt.2017.04.008. Epub 2017 Apr 26.
- Atilgan E, Aytar A, Caglar A, Tigli AA, Arin G, Yapali G, Kisacik P, Berberoglu U, Sener HO, Unal E. The effects of Clinical Pilates exercises on patients with shoulder pain: A randomised clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):847-851. doi: 10.1016/j.jbmt.2017.02.003. Epub 2017 Mar 4.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pilates effect in shoulder SIS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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