Effect of Pilates Exercises and Diaphragm Manual Therapy Techniques in Rotator Cuff Tendinopathy

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).

Study Overview

• Status: Recruiting
• Conditions: Shoulder Rotator Cuff Tendinopathy; Shoulder Tendinitis
• Intervention / Treatment: Other: pilates exercise and diaphragm manual technique

Detailed Description

Musculoskeletal complains are common work-related problems in Egypt. Egyptian preparatory school teachers were 96%. Dental society revealed high response rate (93%) with 53.8% have complains related to neck/shoulder .Physical therapists (PTs) are frequently exposed to work-related musculoskeletal disorders .Shoulder problems represent (47.7%).Printing workers and municipal solid waste collectors are another group having high prevalence of work-related musculoskeletal disorders that might be related to some individual factors (age, BMI, and duration of employment).

Since pilates shoulder exercise influence shoulder function and pain and to considering the relationship between shoulder muscles and the thoracic cage expansion. Consequently, it is worthy to investigate the efficacy of Pilates exercises program with diaphragm manual therapy techniques in pain intensity, pain threshold, shoulder lateral rotator strength, abduction strength and shoulder function on patient with rotator cuff tendinopathy aiming for function improvement and pain decrease. Therefore, this study is being conducted for this purpose.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amaal Ibrahim, professor; Phone Number: 00201111287279; Email: rehabtareqmohamad@gmail.com
• Study Contact Backup: Name: Gada Abed Allaha, professor; Phone Number: 00201002108267; Email: maha.elgharib@fpt.bu.edu.eg

Study Locations

• Egypt
  • Ramsis Saint Abbassia , Cairo.
    • Cairo, Ramsis Saint Abbassia , Cairo., Egypt, 222
      • Recruiting
      • MOH
      • Contact: mohmad ali, pofessor; Phone Number: 00201111287279; Email: rehabtareqmohamad@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients diagnosed with rotator cuff tendinopathy for duration greater than three months
2. Body Mass Index between 18.5 and 24.9
3. patients complain of shoulder pain at the tip of the shoulder and the upper, outer arm.
4. pain during resisted arm test (usually abduction and/or lateral rotation) (

Exclusion Criteria:

• 1. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates Group; fifteen 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	Other: pilates exercise and diaphragm manual technique; pilates exercises; Other Names: exercises
Experimental: diaphragmatic Group; fifteen 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	Other: pilates exercise and diaphragm manual technique; pilates exercises; Other Names: exercises
Active Comparator: traditional Group; fifteen 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	Other: pilates exercise and diaphragm manual technique; pilates exercises; Other Names: exercises
Experimental: pilates and diaphragmatic Group; fifteen 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	Other: pilates exercise and diaphragm manual technique; pilates exercises; Other Names: exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
strength of shoulder muscle	hand heled dynamometer	4 weeks
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

Collaborators and Investigators

• Sponsor: Ministry of Health and Population, Egypt
• Collaborators: Cairo University
• Investigators: Study Director: Mohamed Ali, professor, Ministry of Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: physical therapy; Pilates exercise; Shoulder Tendinitis; shoulder rotator cuff tendinopathy; diaphragmatic respiratory technique
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: P.T.REC/012/004001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No