Clincosm LogoSign in Get a demo

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

Sponsor
Ministry of Health and Population, Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT06148805
Collaborator
Cairo University (Other)
60
Enrollment
1
Location
4
Arms
15
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: pilates exercise and diaphragm manual technique
 N/A

Detailed Description

Musculoskeletal complains are common work-related problems in Egypt. Egyptian preparatory school teachers were 96% (El Gendy and Korish,2017). Dental society revealed high response rate (93%) with 53.8% have complains related to neck/shoulder (Diaa Eldien et al.,2021).Physical therapists (PTs) are frequently exposed to work-related musculoskeletal disorders .Shoulder problems represent (47.7%) (Abu-Taleb and Rehan, 2021).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) (Abou-ElWafa et al.,2012 and Mourad, 2021).

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients diagnosed with rotator cuff tendinopathy for duration greater than three months (Eda and Emin,2016). 40 and 60 years of age from both genders (Yamamoto et al.,2019) Patient's BMI within normal range between 18.5 and 24.9 (Gumina et al.,2014) 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). The arm pain during resisted testing (usually abduction and/or lateral rotation) (Eda and Emin,Patients diagnosed with rotator cuff tendinopathy for duration greater than three months (Eda and Emin,2016). 40 and 60 years of age from both genders (Yamamoto et al.,2019) Patient's BMI within normal range between 18.5 and 24.9 (Gumina et al.,2014) 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). The arm pain during resisted testing (usually abduction and/or lateral rotation) (Eda and Emin,
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Pilates Exercises and Diaphragm Manual Therapy Techniques in Rotator Cuff Tendinopathy
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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: Group B

    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

    		•
    Experimental: Group c

    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: Group D

    fifteen patients diagnosed with shoulder rotator cuff tendinopathy for at least 3 months randomly selected from ministry of health units will receive 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. shoulder pain [4 weeks]

      visual analog scale pain threshold will be carried out by pressure algometer

    2. strength of shoulder muscle [4 weeks]

      hand heled dynamometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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,

    Exclusion Criteria:
      1. Stiff shoulder such as adhesive capsulitis 2. Any previse 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MOH Cairo Ramsis Saint Abbassia , Cairo. Egypt 222

    Sponsors and Collaborators

    • Ministry of Health and Population, Egypt
    • Cairo University

    Investigators

    • Study Director: Mohamed Ali, professor, Ministry of Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mona Samir Ismail El shahawy, mona samir ismail el shahawy, Adel Rashad Ahmed, Amaal Hassan Ibrahim,Mohamed Ali Amin, Ghada Abed Elmoniem Abed Allaha, Ministry of Health and Population, Egypt
    ClinicalTrials.gov Identifier:
    NCT06148805
    Other Study ID Numbers:
    • P.T.REC/012/004001
    First Posted:
    Nov 28, 2023
    Last Update Posted:
    Nov 28, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mona Samir Ismail El shahawy, mona samir ismail el shahawy, Adel Rashad Ahmed, Amaal Hassan Ibrahim,Mohamed Ali Amin, Ghada Abed Elmoniem Abed Allaha, Ministry of Health and Population, Egypt
    Shoulder Tendinitis
    shoulder rotator cuff tendinopathy
    Pilates exercise
    diaphragmatic respiratory technique
    physical therapy
    Additional relevant MeSH terms:
    Tendinopathy

    Study Results

    No Results Posted as of Nov 28, 2023