- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05584345
EFFECTS OF BREATHING EXERCISES ON PAIN AND FUNCTIONALITY IN ROTATOR CUFF TEARS: A RANDOMIZED CONTROLLED TRIAL
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 Locations
-
-
-
Istanbul, Turkey (Türkiye), 34820
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The participants were between the ages of 30 and 55
- No history of shoulder surgery
- Exhibited restricted shoulder joint range of motion,
- A diagnosed rotator cuff tear
Exclusion Criteria:
- individuals with a history of significant shoulder trauma
- anatomical deformities, skeletal fractures, diagnosed orthopedic or rheumatologic disorders, participation in a physiotherapy program within the last six months
- Presence of a cardiac pacemaker, current infections, recent myocardial infarction (within the last six months), or any other condition that could interfere with their ability to perform the prescribed exercises
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: Conventional therapy
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.
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.
In addition, participants will receive manual therapy techniques, including Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding.
Each manual therapy technique was performed with 10 repetitions per participant
|
|
Experimental: breathing exercises and conventional therapy program
In addition to traditional physiotherapy, respiratory exercises will be applied.
|
In addition to the treatment program applied in conventional therapy and manual therapy,, participants in this group also will perform diaphragmatic breathing exercises, pursed-lip breathing exercises, and relaxation breathing exercises.
Each breathing exercise will be performed with 10 repetitions under physiotherapist supervision.
Participants were also asked to continue the breathing exercises at home, performing them three times a day with 10 repetitions per session for a duration of six weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog scale (VAS)
Time Frame: From enrollment to the end of treatment at six weeks
|
Pain intensity will be with VAS that is a tool commonly used to assess the intensity of musculoskeletal pain (18).
The VAS will be used to evaluate the level of shoulder pain experienced by participants at rest, and during activity.
Participants were asked to rate their pain intensity on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain."
The participants' responses will be recorded in the case report forms.
|
From enrollment to the end of treatment at six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goniometric Measurement
Time Frame: From enrollment to the end of treatment at six weeks
|
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 enrollment to the end of treatment at six weeks
|
|
DASH
Time Frame: From enrollment to the end of treatment at six weeks
|
The DASH scale, created by the American Academy of Orthopedic Surgeons in collaboration with other professional organizations, is a standardized instrument used to evaluate physical limitations and functional impairments in individuals with upper extremity conditions.
The DASH questionnaire includes three distinct subdomains.
The first section consists of 30 questions, with 21 items focusing on the patient's difficulties in performing daily activities, five items assessing symptoms, and the remaining four items addressing social functioning, work productivity, sleep quality, and self-confidence.
Higher scores on the DASH questionnaire indicate greater levels of disability and functional limitation, whereas lower scores reflect less disability and better functional status
|
From enrollment to the end of treatment at six weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary Assesments
Time Frame: From enrollment to the end of treatment at six weeks
|
A firstMed SP-10 electronic handheld spirometer will be used to evaluate respiratory function (Fig. 3).
Spirometers are devices that measure airflow or volume changes over time during inspiration and expiration.
They represent the most fundamental test method for identifying and quantifying abnormalities or dysfunctions in pulmonary function.
Participants will be seated in a chair in a relaxed upright position.
A nose clip will be applied to prevent air leakage.
Each participant was instructed to place a disposable mouthpiece between their lips and teeth, ensuring no air escaped.
They were then encouraged to perform a rapid and deep inspiration followed immediately by a forceful and complete expiration.
Participants will be expected to exhale for at least 6 seconds.
The test will be terminated once adequate expiration will be achieved.
Among at least three properly performed consecutive trials, the highest value will be recorded.
|
From enrollment to the end of treatment at six weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Burak Menek, PhD, Medipol University
- Principal Investigator: UMUT İSLAM TAYBOĞA, RA, Medipol University
- Principal Investigator: Sule Ayan, Msc, 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-10840098-202.3.02-240
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.
Clinical Trials on Rotator Cuff Syndrome
-
Elite College of Management Sciences, Gujranwala...CompletedRotator Cuff Tendinopathy | Rotator Cuff SyndromePakistan
-
Rafeef Hassan AsiriActive, not recruitingRotator Cuff Tendonitis | Rotator Cuff Syndrome | Shoulder Pain SyndromeSaudi Arabia
-
Tartu University HospitalUniversity of TartuNot yet recruitingRotator Cuff Tears | Rotator Cuff Syndrome
-
Ivan WongCompletedRotator Cuff Injury | Full Thickness Rotator Cuff Tear | Rotator Cuff Syndrome | Disorder of Rotator Cuff | Skin Graft (Allograft) (Autograft) FailureCanada
-
Clinical Exercise Physiology and Rehabilitation...Not yet recruitingRotator Cuff Tear or Rupture, Not Specified as Traumatic | Rotator Cuff Tears | Rotator Cuff Tendinosis | Rotator Cuff Syndrome | Rotator Cuff Impingement
-
Université de SherbrookeCentre de recherche du Centre hospitalier universitaire de SherbrookeCompletedRotator Cuff Injuries | Rotator Cuff Tendinosis | Rotator Cuff Impingement Syndrome | Rotator Cuff Syndrome of Shoulder and Allied Disorders | Rotator Cuff Impingement
-
Medipol UniversityActive, not recruitingRotator Cuff Injuries | Rotator Cuff SyndromeTurkey (Türkiye)
-
Guna S.p.aCompletedRotator Cuff Injuries | Tendinopathy | Rotator Cuff Tendinitis | Syndrome Rotator Cuff | Tendinoses, Rotator CuffItaly
-
OrthoSpace Ltd.CompletedRotator Cuff SyndromeUnited States, Canada
-
Cairo UniversityRecruitingRotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Impingement SyndromeEgypt
Clinical Trials on Conventional Treatment and manual therapy
-
Cairo UniversityCompletedChronic Obstructive Pulmonary DiseaseEgypt
-
Istanbul Medipol University HospitalCompleted
-
Riphah International UniversityCompletedUPPER CROSS SYNDROMEPakistan
-
University Hospital, GhentCompletedChronic PeriodontitisBelgium
-
Bartın UnıversityThe Scientific and Technological Research Council of TurkeyEnrolling by invitationBruxism | Physiotherapy | Orafacial PainTurkey
-
Universidad Complutense de MadridCompleted
-
Atılım UniversityNot yet recruitingEfficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back PainCentral Sensitization | Manual TherapyTurkey
-
Universidad Europea de MadridCompletedLymphatic Diseases
-
Clear Passage Therapies, IncUnknownQuality of Life | Bowel Obstruction | Small Bowel ObstructionUnited States
-
Riphah International UniversityCompletedMechanical Low Back PainPakistan