NCT06148805

Brief Summary

  1. 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. 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. 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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

November 19, 2023

Last Update Submit

January 12, 2024

Conditions

Keywords

Shoulder Tendinitisshoulder rotator cuff tendinopathyPilates exercisediaphragmatic respiratory techniquephysical therapy

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

EXPERIMENTAL

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

diaphragmatic Group

EXPERIMENTAL

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

traditional Group

ACTIVE COMPARATOR

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 and diaphragmatic Group

EXPERIMENTAL

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

Interventions

pilates exercises

Also known as: exercises
Pilates Groupdiaphragmatic Grouppilates and diaphragmatic Grouptraditional Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

MOH

Cairo, Ramsis Saint Abbassia , Cairo., 222, Egypt

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mohamed Ali, professor

    Ministry of Health

    STUDY DIRECTOR

Central Study Contacts

Amaal Ibrahim, professor

CONTACT

Gada Abed Allaha, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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,
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

Locations