Investigation of the Effect of Respiratory Exercises on Pain and Functionality in Individuals With Rotator Cuff Syndrome

July 3, 2023 updated by: burak menek, Istanbul Medipol University Hospital
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.

Study Overview

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
Experimental: RESPIRATORY EXERCISES GROUP
In addition to traditional physiotherapy and respiratory exercises wiil be applied.
Diaphragmatic breathing and thoracic expansion breathing exercises will be applied 5 days a week.

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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Goniometric Measurement
Time Frame: from pre-interventional time to post-interventional about 1st week
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
The Disabilities of the Arm, Shoulder and Hand (DASH)
Time Frame: from pre-interventional time to post-interventional about 1st week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2022

Primary Completion (Actual)

July 3, 2023

Study Completion (Actual)

July 3, 2023

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Rotator Cuff Syndrome

Clinical Trials on Conventional Treatment

3
Subscribe