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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05584345
Other study ID # E-10840098-772.02-4787
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2022
Est. completion date July 3, 2023

Study information

Verified date July 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

As it causes pain and disability in individuals with rotator cuff lesions, which is one of the most common causes of shoulder pain, it affects performance in activities of daily living. Shoulder pain significantly affects the quality of life of individuals. The aim of conventional treatment in Rotator Cuff injuries is to reduce the inflammation in the area and to enable the shoulder to perform its normal functions. Conventional treatment is to restore muscle balance in the shoulder area. Muscle balance is achieved by strengthening the teres minor, infraspinatus, and subscapularis, which are also the humeral head depressors, and by strengthening the serratus anterior, levator scapula. For strengthening, the shoulder must have a full range of motion. In our study, stretching exercises, cold pack, Ultrasound, TENS, wand, and Codman exercises, which are classical physiotherapy methods, will be applied to all three groups. There are also studies in the literature investigating the effects of traditional physiotherapy methods on individuals with shoulder Rotator Cuff syndrome. The benefits of breathing exercises on pain, shoulder joint range of motion, and balance have all been researched in the literature. Increased diaphragm activity also guarantees that posture and body positions are maintained healthily. Diaphragm activity generally alters how an individual perceives pain. Diaphragmatic breathing is a therapeutic approach for musculoskeletal disorders.


Description:

Breathing techniques have been demonstrated to reduce shoulder pain and increase ROM at the literature. However, no study has been found on the effectiveness of breathing exercises applied in addition to conventional physiotherapy in individuals with Rotator Cuff syndrome. Based on all of this knowledge, it was designed for this study to examine the efficacy of breathing exercises used in combination with traditional physiotherapy in patients with Rotator Cuff syndrome.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 3, 2023
Est. primary completion date July 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Restricted shoulder joint range of motion 2. Having Rotator Cuff Syndrome 3. Not having had any shoulder surgery 4. Being between the ages of 18 - 65 Exclusion Criteria: 1. Major trauma to the shoulder 2. Anatomical deformities and skeletal system fractures 3. Diagnosed orthopedic or rheumatological diseases 4. Being included in a physiotherapy program in the last 6 months 5. Having a cardiac pacemaker 6. Presence of active infection 7. Myocardial infarction in the last 6 months 8. Participants who have any illness that prevents them from doing the exercises will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional Treatment
Cold pack, ultrasound, TENS, finger ladder, Codman, shoulder wheel, and Wand exercises, as well as stretching and capsule exercises, will be used in addition to conventional physiotherapy. Exercises with a wand will be performed 10 times in each direction. There will be 30 repetitions in each direction of the Codman exercises. 5 days a week, for a total of 30 sessions, the afflicted shoulder will get 6 minutes of daily US treatment, with complete contact to the shoulder area and at a right angle. All patients will receive manual stretching in the shoulder flexion, abduction, extension, external rotation, and internal rotation directions. The physiotherapist will perform these stretches 5 times in each direction, pausing for 20 seconds at the conclusion of each repeat. TENS will be applied for 20 minutes. In addition, a 15-minute cold pack application will be made to the shoulder region. The application of theraband strengthening exercises will depend on the patients' state.
Respiratory Exercises
Diaphragmatic breathing and thoracic expansion breathing exercises will be applied 5 days a week.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Rating Scale (NRS) NRS is widely used in research and clinical settings to represent pain intensity. NRS is stated as the absence of pain as 0 and the worst possible pain as 10. from pre-interventional time to post-interventional about 1st week
Secondary Goniometric Measurement In our study, the degrees of flexion, extension, abduction, internal rotation, and external rotation of the affected shoulder will be measured by means of a universal goniometer. Flexion and abduction 0-180 degrees, extension 45 degrees, internal and external rotation 0-90 degrees will be taken as reference. from pre-interventional time to post-interventional about 1st week
Secondary The Disabilities of the Arm, Shoulder and Hand (DASH) Introduced by the American Academy of Orthopedic Surgeons and other organizations, DASH is a scale that evaluates physical limitations and function in upper extremity problems. The DASH questionnaire includes three sub-parameters. The first part contains 30 questions; 21 questions measure the patient's difficulty in daily life functions, 5 questions measure symptoms, and the other 4 questions measure social function, work, sleep, and self-confidence. A 4-question section (optionally answered Business Model (DASHFS)) measures the patient's disability in working life. from pre-interventional time to post-interventional about 1st week
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