Rotator Cuff SyndromeNCT07086066
Diaphragm Mobilization With Rotator Cuff Lesions
A study testing Diaphragm mobilization and conventional physical therapy in people with Rotator Cuff Syndrome, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The glenohumeral joint is the least restricted joint in terms of mobility compared to other joints in the human body. The rotator cuff is a part of the shoulder complex consisting of four muscles and their tendons, which are responsible for stabilizing the shoulder joint. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Rotator Cuff Syndrome
- What is being tested?
- Diaphragm mobilization and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Jun 2025
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals aged between 25 and 55
- Individuals diagnosed with a rotator cuff injury through radiological methods
- Individuals experiencing severe pain (VAS ≥ 3) and functional loss
- Individuals who are willing to participate in the study and have signed the written informed consent form after understanding the purpose and procedure of the study
Who cannot join
- Individuals with a history of rotator cuff surgery
- Individuals with a history of shoulder subluxation
- Individuals with a history of SLAP lesions
- Individuals with respiratory system diseases
- Individuals with nerve damage (e.g., brachial plexus lesions) or neurological disorders that may affect shoulder movements
- Individuals with psychological disorders (e.g., depression, anxiety) that may affect pain perception
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Diaphragm Mobilization on Range of Motion, Function, and Pain in Patients With Rotator Cuff Lesions
The glenohumeral joint is the least restricted joint in terms of mobility compared to other joints in the human body. The rotator cuff is a part of the shoulder complex consisting of four muscles and their tendons, which are responsible for stabilizing the shoulder joint. These muscles are the supraspinatus, infraspinatus, teres minor, and subscapularis. The supraspinatus muscle enables shoulder abduction, infraspinatus and teres minor provide external rotation, and the subscapularis is responsible for internal rotation.
The presence of a rotator cuff lesion is the most common cause of shoulder pain. It usually results from the tear, inflammation, or injury of one or more rotator cuff muscles. It is more prevalent in elderly individuals and is characterized by severe shoulder pain, limited range of motion, and functional loss. These symptoms negatively impact the patient's performance and significantly reduce their quality of life.
Read more
The diaphragm is a large, dome-shaped muscle and the primary muscle of respiration. It is innervated by the phrenic nerve, which is connected to the vagus nerve. During breathing, the diaphragm's movements can directly or indirectly influence the sympathetic and parasympathetic nervous systems, thereby modulating pain perception in the body.
Moreover, there is a significant relationship between the shoulder and diaphragm in terms of myofascial connections and neural innervation. Effective functioning of the diaphragm not only contributes to proper respiration but also positively affects spinal mobility and overall posture. It supports the efficiency of upper body structures such as the cervical spine, shoulder, and neck.
Proper diaphragmatic function contributes to core stability, which in turn may reduce the load on shoulder structures. Manual techniques targeting the diaphragm can enhance its function, potentially reducing the mechanical load on the shoulder complex, alleviating pain, and improving the patient's overall functional capacity.
Read the detailed description
This randomized controlled study aims to evaluate the clinical effects of diaphragm mobilization on joint range of motion, pain, and functional status in individuals diagnosed with rotator cuff lesions. The study will be conducted at Sancak Medical Physical Therapy Center between February 10, 2025, and March 15, 2025. Fifty volunteer participants, both male and female, aged between 25 and 55, will be included. All participants will have clinically diagnosed and radiologically confirmed rotator cuff injuries, accompanied by significant pain or functional limitation, indicated by a Visual Analog Scale (VAS) score greater than 3. Before participating in the study, each individual will provide informed consent.
Participants will be randomly assigned to one of two groups: the experimental group or the control group. Demographic information such as age, gender, occupation, educational status, and body mass index will be collected prior to treatment. Pain levels will be assessed using the Visual Analog Scale (VAS), a simple and widely accepted tool where 0 indicates no pain and 10 represents the most severe pain imaginable. Range of motion will be measured using a universal goniometer, specifically focusing on shoulder flexion, abduction, internal rotation, and external rotation angles. Functional capacity will be evaluated with the Upper Extremity Functional Index (UEFI), a self-reported questionnaire used to measure disability in individuals with upper extremity musculoskeletal disorders. The UEFI consists of 20 items, and the total score ranges from 0 to 80, with higher scores indicating better function.
Assessments will be carried out at baseline and repeated at the end of the six-week intervention period. The experimental group will receive a combination of conventional physical therapy and diaphragm mobilization. Treatment will occur three times per week, with each session lasting between 40 and 60 minutes over six consecutive weeks. Each session will begin with a 20-minute application of transcutaneous electrical nerve stimulation (TENS), followed by 10 minutes of cryotherapy. Diaphragm mobilization will then be performed while the participant lies in a relaxed supine position. The physiotherapist will palpate the diaphragm and teach the participant diaphragmatic breathing techniques. During expiration, the diaphragm will be mobilized in a posterior and inferior direction. This process will be repeated 10 times in each session. Following diaphragm mobilization, the therapist will apply posterior and inferior gliding techniques to the glenohumeral joint, followed by capsular stretching. Functional rehabilitation will include wand exercises performed in two sets of 10 repetitions and finger ladder exercises involving shoulder flexion and abduction.
The control group will receive only conventional physical therapy. As with the experimental group, therapy will be delivered three times per week for six weeks, with each session lasting between 40 and 60 minutes. Each session will include 20 minutes of TENS and 10 minutes of cryotherapy, followed by posterior and inferior gliding techniques on the glenohumeral joint and capsular stretching. Functional exercises will also include wand exercises (two sets of 10 repetitions) and finger ladder exercises targeting shoulder flexion and abduction, but without the addition of diaphragm mobilization techniques.
This study is designed to investigate whether incorporating diaphragm mobilization into a traditional rehabilitation program yields superior outcomes in reducing pain, improving joint mobility, and enhancing upper extremity function compared to conventional therapy alone. By examining the neuromuscular and postural influences of the diaphragm, the study seeks to identify a potentially valuable and underutilized therapeutic technique that could support shoulder rehabilitation protocols, particularly in individuals with rotator cuff pathology.
- Conditions
- Rotator Cuff Syndrome
- Being tested
- Diaphragm mobilization, conventional physical therapy
- Keywords
- pain, range of motion, function
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm mobilizationOther
This group underwent treatment three times a week, with each session lasting 40 to 60 minutes, over a period of six weeks. Diaphragm mobilization included techniques aimed at increasing muscle elasticity, improving postural balance, and reducing pain by stimulating the sympathetic and parasympathetic nervous systems. In each session, participants received 20 minutes of TENS and 10 minutes of cryotherapy. Following this, diaphragm mobilization was applied. During the application, participants were positioned comfortably in the supine position. The physiotherapist palpated the diaphragm, instructed the participant in diaphragmatic breathing, and asked them to take a deep diaphragmatic breath. During expiration, the diaphragm was mobilized in the posterior and inferior directions. This mobilization was performed 10 times per session. Following that, posterior glide and inferior glide techniques were performed.
conventional physical therapyOther
As with the experimental group, therapy will be delivered three times per week for six weeks, with each session lasting between 40 and 60 minutes. Each session will include 20 minutes of TENS and 10 minutes of cryotherapy, followed by posterior and inferior gliding techniques on the glenohumeral joint and capsular stretching. Functional exercises will also include wand exercises (two sets of 10 repetitions) and finger ladder exercises targeting shoulder flexion and abduction, but without the addition of diaphragm mobilization techniques.
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm mobilization group | Experimental | The experimental group received conventional physical therapy and diaphragm mobilization. Receives: Other: Diaphragm mobilization; Other: conventional physical therapy |
| standard physiotherapy group | Active comparator | The control group will receive only conventional physical therapy. Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
The range of motion will be evaluated using a universal goniometer to measure and document the angles of shoulder flexion, abduction, internal rotation, and external rotation. This instrument allows for reliable and standardized joint angle assessments, contributing to accurate monitoring of mobility improvements throughout the intervention.
Measured: through study completion, an average of 3 months
subjective pain
The Visual Analog Scale (VAS) will evaluate heel pain by asking participants to mark their pain level on a 10 cm scale, where 0 means no pain and 10 signifies severe pain, based on their experience over the past week.
Measured: through study completion, an average of 3 months.
Upper extremity function
The "Upper Extremity Functional Index" will be used for functional assessment. The Upper Extremity Functional Index is a self-administered questionnaire that measures disability in individuals with upper extremity orthopedic conditions. The questionnaire includes 20 activities, and the patient is asked to rate the difficulty of completing each activity. The scores from the 20 questions are summed to obtain a maximum possible score of 80. The lowest possible score is 0. Lower scores indicate greater difficulty in performing upper extremity activities.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Mar 2025
- Primary completion30 May 2025
- Study completion30 Jun 2025
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
- Model description
- There were two groups in the study. The experimental group received conventional physical therapy combined with diaphragm mobilization. The control group received only conventional physical therapy without diaphragm mobilization.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Muhammed Fatih Kavak, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086066
- Sponsor's protocol ID
- 61351342/020-827
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 25 Jul 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Diaphragm Mobilization on Range of Motion, Function, and Pain in Patients With Rotator Cuff Lesions
- ClinicalTrials.gov ID
- NCT07086066
- Acronym / sponsor ID
- 61351342/020-827
- Conditions
- Rotator Cuff Syndrome
- Keywords
- pain, range of motion, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Jul 2025 (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.
The glenohumeral joint is the least restricted joint in terms of mobility compared to other joints in the human body. The rotator cuff is a part of the shoulder complex consisting of four muscles and their tendons, which are responsible for stabilizing the shoulder joint. These muscles are the supraspinatus, infraspinatus, teres minor, and subscapularis. The supraspinatus muscle enables shoulder abduction, infraspinatus and teres minor provide external rotation, and the subscapularis is responsible for internal rotation.
The presence of a rotator cuff lesion is the most common cause of shoulder pain. It usually results from the tear, inflammation, or injury of one or more rotator cuff muscles. It is more prevalent in elderly individuals and is characterized by severe shoulder pain, limited range of motion, and functional loss. These symptoms negatively impact the patient's performance and significantly reduce their quality of life.
The diaphragm is a large, dome-shaped muscle and the primary muscle of respiration. It is innervated by the phrenic nerve, which is connected to the vagus nerve. During breathing, the diaphragm's movements can directly or indirectly influence the sympathetic and parasympathetic nervous systems, thereby modulating pain perception in the body.
Moreover, there is a significant relationship between the shoulder and diaphragm in terms of myofascial connections and neural innervation. Effective functioning of the diaphragm not only contributes to proper respiration but also positively affects spinal mobility and overall posture. It supports the efficiency of upper body structures such as the cervical spine, shoulder, and neck.
Proper diaphragmatic function contributes to core stability, which in turn may reduce the load on shoulder structures. Manual techniques targeting the diaphragm can enhance its function, potentially reducing the mechanical load on the shoulder complex, alleviating pain, and improving the patient's overall functional capacity.
Detailed description
This randomized controlled study aims to evaluate the clinical effects of diaphragm mobilization on joint range of motion, pain, and functional status in individuals diagnosed with rotator cuff lesions. The study will be conducted at Sancak Medical Physical Therapy Center between February 10, 2025, and March 15, 2025. Fifty volunteer participants, both male and female, aged between 25 and 55, will be included. All participants will have clinically diagnosed and radiologically confirmed rotator cuff injuries, accompanied by significant pain or functional limitation, indicated by a Visual Analog Scale (VAS) score greater than 3. Before participating in the study, each individual will provide informed consent.
Participants will be randomly assigned to one of two groups: the experimental group or the control group. Demographic information such as age, gender, occupation, educational status, and body mass index will be collected prior to treatment. Pain levels will be assessed using the Visual Analog Scale (VAS), a simple and widely accepted tool where 0 indicates no pain and 10 represents the most severe pain imaginable. Range of motion will be measured using a universal goniometer, specifically focusing on shoulder flexion, abduction, internal rotation, and external rotation angles. Functional capacity will be evaluated with the Upper Extremity Functional Index (UEFI), a self-reported questionnaire used to measure disability in individuals with upper extremity musculoskeletal disorders. The UEFI consists of 20 items, and the total score ranges from 0 to 80, with higher scores indicating better function.
Assessments will be carried out at baseline and repeated at the end of the six-week intervention period. The experimental group will receive a combination of conventional physical therapy and diaphragm mobilization. Treatment will occur three times per week, with each session lasting between 40 and 60 minutes over six consecutive weeks. Each session will begin with a 20-minute application of transcutaneous electrical nerve stimulation (TENS), followed by 10 minutes of cryotherapy. Diaphragm mobilization will then be performed while the participant lies in a relaxed supine position. The physiotherapist will palpate the diaphragm and teach the participant diaphragmatic breathing techniques. During expiration, the diaphragm will be mobilized in a posterior and inferior direction. This process will be repeated 10 times in each session. Following diaphragm mobilization, the therapist will apply posterior and inferior gliding techniques to the glenohumeral joint, followed by capsular stretching. Functional rehabilitation will include wand exercises performed in two sets of 10 repetitions and finger ladder exercises involving shoulder flexion and abduction.
The control group will receive only conventional physical therapy. As with the experimental group, therapy will be delivered three times per week for six weeks, with each session lasting between 40 and 60 minutes. Each session will include 20 minutes of TENS and 10 minutes of cryotherapy, followed by posterior and inferior gliding techniques on the glenohumeral joint and capsular stretching. Functional exercises will also include wand exercises (two sets of 10 repetitions) and finger ladder exercises targeting shoulder flexion and abduction, but without the addition of diaphragm mobilization techniques.
This study is designed to investigate whether incorporating diaphragm mobilization into a traditional rehabilitation program yields superior outcomes in reducing pain, improving joint mobility, and enhancing upper extremity function compared to conventional therapy alone. By examining the neuromuscular and postural influences of the diaphragm, the study seeks to identify a potentially valuable and underutilized therapeutic technique that could support shoulder rehabilitation protocols, particularly in individuals with rotator cuff pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There were two groups in the study. The experimental group received conventional physical therapy combined with diaphragm mobilization. The control group received only conventional physical therapy without diaphragm mobilization.
| Arm | Type | Receives |
|---|---|---|
| Diaphragm mobilization group | Experimental | Other: Diaphragm mobilization, Other: conventional physical therapyThe experimental group received conventional physical therapy and diaphragm mobilization. |
| standard physiotherapy group | Active comparator | Other: conventional physical therapyThe control group will receive only conventional physical therapy. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals aged between 25 and 55
- Individuals diagnosed with a rotator cuff injury through radiological methods
- Individuals experiencing severe pain (VAS ≥ 3) and functional loss
- Individuals who are willing to participate in the study and have signed the written informed consent form after understanding the purpose and procedure of the study
Key exclusion criteria (7 listed)
- Individuals with a history of rotator cuff surgery
- Individuals with a history of shoulder subluxation
- Individuals with a history of SLAP lesions
- Individuals with respiratory system diseases
- Individuals with nerve damage (e.g., brachial plexus lesions) or neurological disorders that may affect shoulder movements
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 |
|---|---|---|
| Diaphragm mobilizationThis group underwent treatment three times a week, with each session lasting 40 to 60 minutes, over a period of six weeks. Diaphragm mobilization included techniques aimed at increasing muscle elasticity, improving postural balance, and reducing pain by stimulating the sympathetic and parasympathetic nervous systems. In each session, participants received 20 minutes of TENS and 10 minutes of cryotherapy. Following this, diaphragm mobilization was applied. During the application, participants were positioned comfortably in the supine position. The physiotherapist palpated the diaphragm, instructed the participant in diaphragmatic breathing, and asked them to take a deep diaphragmatic breath. During expiration, the diaphragm was mobilized in the posterior and inferior directions. This mobilization was performed 10 times per session. Following that, posterior glide and inferior glide techniques were performed. | Other | Diaphragm mobilization group |
| conventional physical therapyAs with the experimental group, therapy will be delivered three times per week for six weeks, with each session lasting between 40 and 60 minutes. Each session will include 20 minutes of TENS and 10 minutes of cryotherapy, followed by posterior and inferior gliding techniques on the glenohumeral joint and capsular stretching. Functional exercises will also include wand exercises (two sets of 10 repetitions) and finger ladder exercises targeting shoulder flexion and abduction, but without the addition of diaphragm mobilization techniques. | Other | Diaphragm mobilization group, standard physiotherapy group |
Primary outcome
range of motion
Time frame: through study completion, an average of 3 months
The range of motion will be evaluated using a universal goniometer to measure and document the angles of shoulder flexion, abduction, internal rotation, and external rotation. This instrument allows for reliable and standardized joint angle assessments, contributing to accurate monitoring of mobility improvements throughout the intervention.
subjective pain
Time frame: through study completion, an average of 3 months.
The Visual Analog Scale (VAS) will evaluate heel pain by asking participants to mark their pain level on a 10 cm scale, where 0 means no pain and 10 signifies severe pain, based on their experience over the past week.
Upper extremity function
Time frame: through study completion, an average of 3 months
The "Upper Extremity Functional Index" will be used for functional assessment. The Upper Extremity Functional Index is a self-administered questionnaire that measures disability in individuals with upper extremity orthopedic conditions. The questionnaire includes 20 activities, and the patient is asked to rate the difficulty of completing each activity. The scores from the 20 questions are summed to obtain a maximum possible score of 80. The lowest possible score is 0. Lower scores indicate greater difficulty in performing upper extremity activities.
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 25 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm mobilization and conventional physical therapy in people with Rotator Cuff Syndrome, run by Uskudar University 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 7 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 25 Jul 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?
range of motion (time frame: through study completion, an average of 3 months). The study lists 3 primary outcomes in all. 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 25 Jul 2025.