Effect of Pilates Exercises and Diaphragm Manual Therapy Techniques in Rotator Cuff Tendinopathy
1 other identifier
interventional
60
1 country
1
Brief Summary
- 1.To investigate the effect of Pilates exercises program on pain intensity, pain threshold, shoulder lateral rotator strength, abduction strength and shoulder function in patients with (RCT).
- 2.To investigate the effect of diaphragm manual therapy techniques on pain intensity, pain threshold, shoulder lateral rotator strength, abduction strength and shoulder function in patients with (RCT).
- 3.To determine the effect of combination between Pilates exercises program and diaphragm manual therapy techniques on pain intensity, pain threshold, shoulder lateral rotator strength, abduction strength and shoulder function in patients with (RCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 19, 2023
CompletedFirst Posted
Study publicly available on registry
November 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 17, 2024
January 1, 2024
7 months
November 19, 2023
January 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
shoulder pain
visual analog scale (scale from 0 to 10 where 0 means no pain and 10 means unbearable pain pain threshold will be carried out by pressure algometer
4 weeks
strength of shoulder muscle
hand heled dynamometer
4 weeks
Study Arms (4)
Pilates Group
EXPERIMENTALfifteen patients diagnosed with shoulder rotator cuff tendinopathy for at least 3 months randomly selected from ministry of health units will receive Pilates exercises program additional to traditional (RCT) physical therapy program containing Hot-Pack (HP), Therapeutic Ultrasound (US) and upper extremity strengthening and stretching exercise program) * The assessment of pain intensity was carried out by visual analog scale * The assessment of pain threshold was carried out by pressure algometer. * The assessment of lateral rotation strength and abduction strength were carried out by hand heled dynamometer. * The assessment of shoulder function was carried out by Arabic version of the Disability of the Arm, Shoulder and Hand (DASH-Arabic) * The assessment of the functional exercise performance was carried out by Six-min walk test
diaphragmatic Group
EXPERIMENTALfifteen patients diagnosed with shoulder rotator cuff tendinopathy for at least 3 months randomly selected from ministry of health units will receive diaphragm manual therapy techniques and traditional rotator cuff tendinopathy physical therapy program containing Hot-Pack (HP), Therapeutic Ultrasound (US) and upper extremity strengthening and stretching exercise program) * The assessment of pain intensity was carried out by visual analog scale * The assessment of pain threshold was carried out by pressure algometer. * The assessment of lateral rotation strength and abduction strength were carried out by hand heled dynamometer. * The assessment of shoulder function was carried out by Arabic version of the Disability of the Arm, Shoulder and Hand (DASH-Arabic) * The assessment of the functional exercise performance was carried out by Six-min walk test
traditional Group
ACTIVE COMPARATORfifteen patients diagnosed with shoulder rotator cuff tendinopathy for at least 3 months randomly selected from ministry of health units will receive 15 received traditional rotator cuff tendinopathy physical therapy program containing Hot-Pack (HP), Therapeutic Ultrasound (US) and upper extremity strengthening and stretching exercise program) * The assessment of pain intensity was carried out by visual analog scale * The assessment of pain threshold was carried out by pressure algometer. * The assessment of lateral rotation strength and abduction strength were carried out by hand heled dynamometer. * The assessment of shoulder function was carried out by Arabic version of the Disability of the Arm, Shoulder and Hand (DASH-Arabic) * The assessment of the functional exercise performance was carried out by Six-min walk test
pilates and diaphragmatic Group
EXPERIMENTALfifteen patients diagnosed with shoulder rotator cuff tendinopathy for at least 3 months randomly selected from ministry of health units will receive diaphragm manual therapy, Pilates exercises program and traditional rotator cuff tendinopathy physical therapy program containing Hot-Pack (HP), Therapeutic Ultrasound (US) and upper extremity strengthening and stretching exercise program) * The assessment of pain intensity was carried out by visual analog scale * The assessment of pain threshold was carried out by pressure algometer. * The assessment of lateral rotation strength and abduction strength were carried out by hand heled dynamometer. * The assessment of shoulder function was carried out by Arabic version of the Disability of the Arm, Shoulder and Hand (DASH-Arabic) * The assessment of the functional exercise performance was carried out by Six-min walk test
Interventions
pilates exercises
Eligibility Criteria
You may qualify if:
- Patients diagnosed with rotator cuff tendinopathy for duration greater than three months
- Body Mass Index between 18.5 and 24.9
- patients complain of shoulder pain at the tip of the shoulder and the upper, outer arm.
- pain during resisted arm test (usually abduction and/or lateral rotation) (
You may not qualify if:
- \. shoulder stiffness 2. Previous dislocation or sublation of shoulder joint. 3. Previous shoulder surgery 4. Glenohumeral joint and acromioclavicular joint degeneration 5. Neurological deficit in the neck or arm 6. Heavy Smokers. 7. Any Cardiopulmonary pathology. 8. Recent Thoracic surgery 9. Any deformity of spine 10. History of Thyroid Disorders 11. Cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ministry of Health and Population, Egyptlead
- Cairo Universitycollaborator
Study Sites (1)
MOH
Cairo, Ramsis Saint Abbassia , Cairo., 222, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohamed Ali, professor
Ministry of Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator mona samir ismail el shahawy, Prof.Adel Rashad Ahmed, prof.Amaal Hassan Ibrahim, clinical Dr.Mohamed Ali Amin, asst. profGhada Abed Elmoniem Abed Allaha
Study Record Dates
First Submitted
November 19, 2023
First Posted
November 28, 2023
Study Start
October 1, 2023
Primary Completion
May 1, 2024
Study Completion
December 31, 2024
Last Updated
January 17, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share