Investigation of the Effect of Respiratory Exercises on Pain and Functionality in Individuals With Rotator Cuff Syndrome
Primary Purpose
Rotator Cuff Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Treatment
Respiratory Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Syndrome focused on measuring respiratory exercises, rotator cuff syndrome, pain
Eligibility Criteria
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.
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CONTROL
RESPIRATORY EXERCISES GROUP
Arm Description
Traditional physiotherapy applications will be applied.
In addition to traditional physiotherapy and respiratory exercises wiil be applied.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05584345
First Posted
September 20, 2022
Last Updated
July 3, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05584345
Brief Title
Investigation of the Effect of Respiratory Exercises on Pain and Functionality in Individuals With Rotator Cuff Syndrome
Official Title
Investigation of the Effect of Respiratory Exercises on Pain and Functionality in Individuals With Rotator Cuff Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
July 3, 2023 (Actual)
Study Completion Date
July 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Syndrome
Keywords
respiratory exercises, rotator cuff syndrome, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
Traditional physiotherapy applications will be applied.
Arm Title
RESPIRATORY EXERCISES GROUP
Arm Type
Experimental
Arm Description
In addition to traditional physiotherapy and respiratory exercises wiil be applied.
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Respiratory Exercises
Intervention Description
Diaphragmatic breathing and thoracic expansion breathing exercises will be applied 5 days a week.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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.
Time Frame
from pre-interventional time to post-interventional about 1st week
Secondary Outcome Measure Information:
Title
Goniometric Measurement
Description
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.
Time Frame
from pre-interventional time to post-interventional about 1st week
Title
The Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
from pre-interventional time to post-interventional about 1st week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BURAK MENEK, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
UMUT İSLAM TAYBOĞA, RA
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ALPER CEYLAN, RA
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34820
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Effect of Respiratory Exercises on Pain and Functionality in Individuals With Rotator Cuff Syndrome
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