EFFECTS OF BREATHING EXERCISES ON PAIN AND FUNCTIONALITY IN ROTATOR CUFF TEARS: A RANDOMIZED CONTROLLED TRIAL
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 18, 2022
CompletedStudy Start
First participant enrolled
October 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2023
CompletedDecember 8, 2025
December 1, 2025
8 months
September 20, 2022
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog scale (VAS)
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 Outcomes (2)
Goniometric Measurement
From enrollment to the end of treatment at six weeks
DASH
From enrollment to the end of treatment at six weeks
Study Arms (2)
Conventional therapy
ACTIVE COMPARATORTraditional physiotherapy applications will be applied.
breathing exercises and conventional therapy program
EXPERIMENTALIn addition to traditional physiotherapy, respiratory exercises will be applied.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University
Istanbul, 34820, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BURAK MENEK, PhD
Medipol University
- PRINCIPAL INVESTIGATOR
UMUT İSLAM TAYBOĞA, RA
Medipol University
- PRINCIPAL INVESTIGATOR
Sule Ayan, Msc
Medipol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 20, 2022
First Posted
October 18, 2022
Study Start
October 30, 2022
Primary Completion
July 3, 2023
Study Completion
July 3, 2023
Last Updated
December 8, 2025
Record last verified: 2025-12