NCT07265765

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

November 25, 2025

Last Update Submit

December 6, 2025

Conditions

Keywords

pilates exercisesubacromial impingement

Outcome Measures

Primary Outcomes (2)

  • shoulder function

    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.

    measured at baseline then after 6 weeks

  • Shoulder Pian

    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

    at baseline and after 6 weeks

Secondary Outcomes (2)

  • shoulder ROM(abduction and internal rotation)

    measured at baseline and after 6 weeks

  • shoulder muscle strength(UT,MT,LT,SA,ER,IR)

    measured at baseline and after 6 weeks

Study Arms (2)

conventional group

ACTIVE COMPARATOR
Behavioral: Conventional

pilates exercise group

EXPERIMENTAL
Behavioral: Pilates exercise

Interventions

ConventionalBEHAVIORAL

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

conventional group

patients who received the Pilates exercise in form of (shoulder drop, chest opener, book opening, scarecrow, dart, quadruped exercise, spine twist exercise).

pilates exercise group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Giza Governorate, 11432, Egypt

Location

Related Publications (9)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Congresses as TopicExercise Movement Techniques

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and OrganizationsPhysical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator (Physical Therapist)

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 5, 2025

Study Start

June 16, 2025

Primary Completion

July 27, 2025

Study Completion

August 18, 2025

Last Updated

December 15, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations