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

NCT ID: NCT06148805

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Shoulder Tendinitis Shoulder Rotator Cuff Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Patients diagnosed with rotator cuff tendinopathy for duration greater than three months (Eda and Emin,2016).
2. 40 and 60 years of age from both genders (Yamamoto et al.,2019)
3. Patient's BMI within normal range between 18.5 and 24.9 (Gumina et al.,2014)
4. patients complain of shoulder pain at the tip of the shoulder and the upper, outer arm. The pain is aggravated by reaching, pushing, pulling, lifting, positioning the arm above the shoulder level, or lying on the side (Stiphen and Micheal,1021).
5. The arm pain during resisted testing (usually abduction and/or lateral rotation) (Eda and Emin,
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

pilates exercise and diaphragm manual technique

Intervention Type OTHER

pilates exercises

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

Group Type EXPERIMENTAL

pilates exercise and diaphragm manual technique

Intervention Type OTHER

pilates exercises

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

Group Type ACTIVE_COMPARATOR

pilates exercise and diaphragm manual technique

Intervention Type OTHER

pilates exercises

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

Group Type EXPERIMENTAL

pilates exercise and diaphragm manual technique

Intervention Type OTHER

pilates exercises

Interventions

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pilates exercise and diaphragm manual technique

pilates exercises

Intervention Type OTHER

Other Intervention Names

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exercises

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Ministry of Health and Population, Egypt

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mona Samir Ismail El shahawy

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Ali, professor

Role: STUDY_DIRECTOR

Ministry of Health

Locations

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MOH

Cairo, Ramsis Saint Abbassia , Cairo., Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amaal Ibrahim, professor

Role: CONTACT

00201111287279

Gada Abed Allaha, professor

Role: CONTACT

00201002108267

Facility Contacts

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mohmad ali, pofessor

Role: primary

00201111287279

Other Identifiers

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P.T.REC/012/004001

Identifier Type: -

Identifier Source: org_study_id

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