Shoulder TendinitisNCT06148805
Effect of Pilates Exercises and Diaphragm Manual Therapy Techniques in Rotator Cuff Tendinopathy
A study testing pilates exercise and diaphragm manual technique in people with Shoulder Tendinitis and Shoulder Rotator Cuff Tendinopathy, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Shoulder Tendinitis, Shoulder Rotator Cuff Tendinopathy
- What is being tested?
- pilates exercise and diaphragm manual technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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) (
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
MOH
Cairo, Ramsis Saint Abbassia , Cairo., 222
mohmad ali, pofessor, 00201111287279, rehabtareqmohamad@gmail.com
About this study
- 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).
- 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).
- 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).
Read the 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.
- Being tested
- pilates exercise and diaphragm manual technique
- Keywords
- Shoulder Tendinitis, shoulder rotator cuff tendinopathy, Pilates exercise, diaphragmatic respiratory technique, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilates exercise and diaphragm manual techniqueOther
Also called exercises
pilates exercises
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: pilates exercise and diaphragm manual technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
strength of shoulder muscle
hand heled dynamometer
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Oct 2023
- Primary completion1 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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,
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Mona Samir Ismail El shahawy, Ministry of Health and Population, Egypt
- Investigators
- Mohamed Ali, professor, Study director, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148805
- Sponsor's protocol ID
- P.T.REC/012/004001
- Status last verified
- Jan 2024
- First submitted
- 19 Nov 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises and Diaphragm Manual Therapy Techniques in Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT06148805
- Acronym / sponsor ID
- P.T.REC/012/004001
- Keywords
- Shoulder Tendinitis, shoulder rotator cuff tendinopathy, Pilates exercise, diaphragmatic respiratory technique, physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Collaborators
- Cairo University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
- 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).
- 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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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,
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: pilates exercise and diaphragm manual techniquefifteen 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 | Experimental | Other: pilates exercise and diaphragm manual techniquefifteen 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 comparator | Other: pilates exercise and diaphragm manual techniquefifteen 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 | Experimental | Other: pilates exercise and diaphragm manual techniquefifteen 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 |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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) (
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pilates exercise and diaphragm manual techniqueAlso: exercisespilates exercises | Other | Pilates Group, diaphragmatic Group, pilates and diaphragmatic Group, traditional Group |
Primary outcome
shoulder pain
Time frame: 4 weeks
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
strength of shoulder muscle
Time frame: 4 weeks
hand heled dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Shoulder Tendinitis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis
Calcific Tendinitis of Shoulder
Recruiting
Electroacupuncture and Cupping for Shoulder Tendinitis
Shoulder Tendinopathy, Shoulder Tendinitis
RecruitingPhase 3
Hyaluronic Acid in Shoulder Tendinopathy
Shoulder Tendinitis
Active, not recruiting
Eccentric Contraction Exercise For Shoulder Pain Syndrome
Shoulder Pain Syndrome, Rotator Cuff Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Ali, professor study director
Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pilates exercise and diaphragm manual technique in people with Shoulder Tendinitis and Shoulder Rotator Cuff Tendinopathy, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amaal Ibrahim, professor (00201111287279, rehabtareqmohamad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder pain (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.