- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05584345
Investigation of the Effect of Respiratory Exercises on Pain and Functionality in Individuals With Rotator Cuff Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: BURAK MENEK, PhD
- Phone Number: +9054444761640
- Email: bmenek@medipol.edu.tr
Study Contact Backup
- Name: UMUT İSLAM TAYBOĞA, RA
- Phone Number: +905397173931
- Email: umut.tayboga@medipol.edu.tr
Study Locations
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Istanbul, Turkey, 34820
- Istanbul Medipol University
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Contact:
- UMUT İSLAM TAYBOĞA, RA
- Phone Number: +905397173931
- Email: umut.tayboga@medipol.edu.tr
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Contact:
- BURAK MENEK, PhD
- Phone Number: +905444761640
- Email: bmenek@medipol.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Restricted shoulder joint range of motion
- Having Rotator Cuff Syndrome
- Not having had any shoulder surgery
- Being between the ages of 18 - 65
Exclusion Criteria:
- Major trauma to the shoulder
- Anatomical deformities and skeletal system fractures
- Diagnosed orthopedic or rheumatological diseases
- Being included in a physiotherapy program in the last 6 months
- Having a cardiac pacemaker
- Presence of active infection
- Myocardial infarction in the last 6 months
- Participants who have any illness that prevents them from doing the exercises will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CONTROL
Traditional physiotherapy applications will be applied.
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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.
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Experimental: RESPIRATORY EXERCISES GROUP
In addition to traditional physiotherapy and respiratory exercises wiil be applied.
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Diaphragmatic breathing and thoracic expansion breathing exercises will be applied 5 days a week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale (NRS)
Time Frame: from pre-interventional time to post-interventional about 1st week
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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.
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from pre-interventional time to post-interventional about 1st week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goniometric Measurement
Time Frame: from pre-interventional time to post-interventional about 1st week
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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.
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from pre-interventional time to post-interventional about 1st week
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The Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: from pre-interventional time to post-interventional about 1st week
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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.
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from pre-interventional time to post-interventional about 1st week
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Collaborators and Investigators
Investigators
- Principal Investigator: ALPER CEYLAN, RA, Medipol University
- Principal Investigator: Burak Menek, PhD, Medipol University
- Principal Investigator: UMUT İSLAM TAYBOĞA, RA, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-4787
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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