Rotator Cuff SyndromeNCT05584345
EFFECTS OF BREATHING EXERCISES ON PAIN AND FUNCTIONALITY IN ROTATOR CUFF TEARS: A RANDOMIZED CONTROLLED TRIAL
A study testing Conventional Treatment and manual therapy and Manual therapy and Respiratory Exercises in people with Rotator Cuff Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- Conventional Treatment and manual therapy and Manual therapy and Respiratory Exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2022to 3 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- Conventional Treatment and manual therapy, Manual therapy and Respiratory Exercises
- Keywords
- respiratory exercises, rotator cuff syndrome, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Treatment and manual therapyOther
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
Manual therapy and Respiratory ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | Traditional physiotherapy applications will be applied. Receives: Other: Conventional Treatment and manual therapy |
| breathing exercises and conventional therapy program | Experimental | In addition to traditional physiotherapy, respiratory exercises will be applied. Receives: Other: Manual therapy and Respiratory Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at six weeks
Secondary outcomes (2)
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.
Measured: From enrollment to the end of treatment at six weeks
DASH
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
Measured: From enrollment to the end of treatment at six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start30 Oct 2022
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burak menek, Istanbul Medipol University Hospital
- Investigators
- BURAK MENEK, PhD, Principal investigator, Medipol UniversityUMUT İSLAM TAYBOĞA, RA, Principal investigator, Medipol UniversitySule Ayan, Msc, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584345
- Sponsor's protocol ID
- E-10840098-202.3.02-240
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF BREATHING EXERCISES ON PAIN AND FUNCTIONALITY IN ROTATOR CUFF TEARS: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT05584345
- Acronym / sponsor ID
- E-10840098-202.3.02-240
- Conditions
- Rotator Cuff Syndrome
- Keywords
- respiratory exercises, rotator cuff syndrome, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Other: Conventional Treatment and manual therapyTraditional physiotherapy applications will be applied. |
| breathing exercises and conventional therapy program | Experimental | Other: Manual therapy and Respiratory ExercisesIn addition to traditional physiotherapy, respiratory exercises will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Treatment and manual therapyCold 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 | Other | Conventional therapy |
| Manual therapy and Respiratory ExercisesIn 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. | Other | breathing exercises and conventional therapy program |
Primary outcome
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.
2 secondary outcomes
Goniometric Measurement
Time frame: From enrollment to the end of treatment at six weeks
DASH
Time frame: From enrollment to the end of treatment at six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BURAK MENEK, PhD principal investigator
Medipol University
UMUT İSLAM TAYBOĞA, RA principal investigator
Medipol University
Sule Ayan, Msc principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Treatment and manual therapy and Manual therapy and Respiratory Exercises in people with Rotator Cuff Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog scale (VAS) (time frame: From enrollment to the end of treatment at six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.