Rotator Cuff InjuriesNCT07180225
Manual Therapy Combined With Breathing
A study testing Conventional therapy+manual therapy and Conventional therapy+manual therapy+breathing exercises in people with Rotator Cuff Injuries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Conventional therapy+manual therapy and Conventional therapy+manual therapy+breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2024to 15 Jul 2024
- 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
- being between 18 and 65 years of age;
- the presence of at least one of the following clinical findings: positive Neer Impingement Test, positive Hawkins-Kennedy Impingement test, or painful arc during active abduction or flexion
- experiencing pain in at least one of the resisted tests for internal rotation, external rotation, abduction, or flexion
- being able to participate in the face-to-face treatment program consisting of a total of 18 sessions
Who cannot join
- a history of upper extremity fracture; undergoing shoulder surgery on the affected side within the past 12 months
- significant shoulder weakness or loss of active shoulder function; the presence of systemic musculoskeletal disorders
- symptom reproduction during active or passive cervical movements; the presence of consciousness disorders, cognitive impairments; and having any diagnosed cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Therapy Combined With Breathing Exercises in Management of Rotator Cuff Impingement Syndrome
Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function.
Read the detailed description
Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function. The study was conducted with fifty-two individuals aged 18-65 diagnosed with rotator cuff impingement syndrome. Individuals who met the inclusion criteria were randomly and equally assigned to two groups. Participants in the control group received the cold pack, TENS, and conventional exercise program. Participants in the intervention group received manual therapy combined with respiratory exercises in addition to this therapy program. All participants received therapy three times a week for a total of six weeks. The Visual Analog Scale (VAS) and Shoulder Pain and Disability Index (SPADI), shoulder range of motion (ROM) assessments, and a spirometer were used for evaluation.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Conventional therapy+manual therapy, Conventional therapy+manual therapy+breathing exercises
- Keywords
- breathing exercises, manual therapy, conventional therapy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapy+manual therapyOther
Conventional therapy contains TENS and physiotherapist-supervised exercise program. These exercises are Wand exercises (15 repetitions each), codman exercises (1 minute in each direction), shoulder wheel exercises (5 minutes total), finger ladder exercises (10 repetitions), isometric exercises (10 repetitions each), capsular stretching exercises (10 repetitions each), pectoral muscle stretching and stabilization exercises (10 repetitions), shoulder stabilization exercises (5 minutes total), and strengthening exercises for the shoulder flexor, extensor, abductor, adductor, internal rotator, and external rotator muscles (15 repetitions each). In addition to them, manual therapy were applied to the shoulder region.
Conventional therapy+manual therapy+breathing exercisesOther
In addition to the treatment program of Group I, breathing exercises were added. Each manual therapy technique was performed with 10 repetitions per participant. Similarly, participants were instructed to perform each breathing exercise with 10 repetitions. They 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 |
|---|---|---|
| GROUP I | Experimental | Participants received conventional TENS applied to painful points in the shoulder region. Following TENS, patients performed a physiotherapist-supervised exercise program.At the beginning of the treatment, participants were provided with normal range of motion exercises and isometric strengthening exercises.Also, Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding techniques were added. Receives: Other: Conventional therapy+manual therapy |
| GROUP II | Experimental | In addition to the treatment program applied in Group 1, participants in the intervention group received the following: Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding, diaphragmatic breathing exercises, pursed-lip breathing exercises, and relaxation breathing exercises. Receives: Other: Conventional therapy+manual therapy+breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation
Pain intensity was assesed with visual anaolg scale (VAS) that is a tool commonly used to assess the intensity of musculoskeletal pain. The VAS was 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 were recorded in the case report forms
Measured: Baseline and 6 weeks
Disability
Shoulder Pain and Disability Index (SPADI) is a self-reported, shoulder specific questionnaire developed to assess pain intensity and disability levels in individuals with musculoskeletal shoulder pain.The disability subscale includes eight items, where patients rate the difficulty, they experienced while performing daily activities in the past week, using a scale from 0 (no difficulty) to 10 (so difficult that assistance is required). The total SPADI score was calculated by converting the total raw score into a percentage. The final score ranges from 0 to 100, with higher scores indicating greater levels of pain and disability
Measured: Baseline and 6 weeks
Range of motion evaluation
A universal goniometer was used to measure the shoulder joint's ROM in flexion, extension, abduction, internal rotation, and external rotation. Measurements were recorded in degrees. Each movement was performed three times, and the average of these three measurements was used for analysis. After each measurement, the participant returned their arm to the neutral position before the next repetition. The normal ROM values for the shoulder joint are as follows: 0-180° for flexion and abduction, 0-45° for extension and adduction, and 0-90° for internal and external rotation
Measured: Baseline and 6 weeks
Pulmonary system evaluation
A firstMed SP-10 electronic handheld spirometer was used to evaluate respiratory function. 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 were expected to exhale for at least 6 seconds. The test was terminated once adequate expiration was achieved. Among at least three properly performed consecutive trials, the highest value was recorded
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start10 Feb 2024
- Primary completion10 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies 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
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yilmaz menek, Istanbul Medipol University Hospital
- Investigators
- MERVE YILMAZ MENEK, PhD, Principal investigator, İstanbul Medipol universityŞULE AYAN, Principal investigator, İstanbul Medipol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180225
- Sponsor's protocol ID
- E-10840098-202.3.02-240-5
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Sep 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy Combined With Breathing Exercises in Management of Rotator Cuff Impingement Syndrome
- ClinicalTrials.gov ID
- NCT07180225
- Acronym / sponsor ID
- E-10840098-202.3.02-240-5
- Conditions
- Rotator Cuff Injuries
- Keywords
- breathing exercises, manual therapy, conventional therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 18 Sep 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.
Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function.
Detailed description
Rotator cuff impingement syndrome is one of the most common causes of shoulder pain and functional limitation, with manual therapy frequently employed in its management. This study aimed to investigate the additional effects of incorporating breathing exercises into manual therapy on pain and function. The study was conducted with fifty-two individuals aged 18-65 diagnosed with rotator cuff impingement syndrome. Individuals who met the inclusion criteria were randomly and equally assigned to two groups. Participants in the control group received the cold pack, TENS, and conventional exercise program. Participants in the intervention group received manual therapy combined with respiratory exercises in addition to this therapy program. All participants received therapy three times a week for a total of six weeks. The Visual Analog Scale (VAS) and Shoulder Pain and Disability Index (SPADI), shoulder range of motion (ROM) assessments, and a spirometer were used for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP I | Experimental | Other: Conventional therapy+manual therapyParticipants received conventional TENS applied to painful points in the shoulder region. Following TENS, patients performed a physiotherapist-supervised exercise program.At the beginning of the treatment, participants were provided with normal range of motion exercises and isometric strengthening exercises.Also, Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding techniques were added. |
| GROUP II | Experimental | Other: Conventional therapy+manual therapy+breathing exercisesIn addition to the treatment program applied in Group 1, participants in the intervention group received the following: Glenohumeral joint (GH) distraction, glenohumeral joint inferior gliding, anterior gliding, and posterior gliding, scapulothoracic joint distraction, scapulothoracic joint superior, inferior, medial, and lateral gliding, diaphragmatic breathing exercises, pursed-lip breathing exercises, and relaxation breathing exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being between 18 and 65 years of age;
- the presence of at least one of the following clinical findings: positive Neer Impingement Test, positive Hawkins-Kennedy Impingement test, or painful arc during active abduction or flexion
- experiencing pain in at least one of the resisted tests for internal rotation, external rotation, abduction, or flexion
- being able to participate in the face-to-face treatment program consisting of a total of 18 sessions
Key exclusion criteria (3 listed)
- a history of upper extremity fracture; undergoing shoulder surgery on the affected side within the past 12 months
- significant shoulder weakness or loss of active shoulder function; the presence of systemic musculoskeletal disorders
- symptom reproduction during active or passive cervical movements; the presence of consciousness disorders, cognitive impairments; and having any diagnosed cardiovascular disease
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 therapy+manual therapyConventional therapy contains TENS and physiotherapist-supervised exercise program. These exercises are Wand exercises (15 repetitions each), codman exercises (1 minute in each direction), shoulder wheel exercises (5 minutes total), finger ladder exercises (10 repetitions), isometric exercises (10 repetitions each), capsular stretching exercises (10 repetitions each), pectoral muscle stretching and stabilization exercises (10 repetitions), shoulder stabilization exercises (5 minutes total), and strengthening exercises for the shoulder flexor, extensor, abductor, adductor, internal rotator, and external rotator muscles (15 repetitions each). In addition to them, manual therapy were applied to the shoulder region. | Other | GROUP I |
| Conventional therapy+manual therapy+breathing exercisesIn addition to the treatment program of Group I, breathing exercises were added. Each manual therapy technique was performed with 10 repetitions per participant. Similarly, participants were instructed to perform each breathing exercise with 10 repetitions. They 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 | GROUP II |
Primary outcome
Pain evaluation
Time frame: Baseline and 6 weeks
Pain intensity was assesed with visual anaolg scale (VAS) that is a tool commonly used to assess the intensity of musculoskeletal pain. The VAS was 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 were recorded in the case report forms
Disability
Time frame: Baseline and 6 weeks
Shoulder Pain and Disability Index (SPADI) is a self-reported, shoulder specific questionnaire developed to assess pain intensity and disability levels in individuals with musculoskeletal shoulder pain.The disability subscale includes eight items, where patients rate the difficulty, they experienced while performing daily activities in the past week, using a scale from 0 (no difficulty) to 10 (so difficult that assistance is required). The total SPADI score was calculated by converting the total raw score into a percentage. The final score ranges from 0 to 100, with higher scores indicating greater levels of pain and disability
Range of motion evaluation
Time frame: Baseline and 6 weeks
A universal goniometer was used to measure the shoulder joint's ROM in flexion, extension, abduction, internal rotation, and external rotation. Measurements were recorded in degrees. Each movement was performed three times, and the average of these three measurements was used for analysis. After each measurement, the participant returned their arm to the neutral position before the next repetition. The normal ROM values for the shoulder joint are as follows: 0-180° for flexion and abduction, 0-45° for extension and adduction, and 0-90° for internal and external rotation
Pulmonary system evaluation
Time frame: Baseline and 6 weeks
A firstMed SP-10 electronic handheld spirometer was used to evaluate respiratory function. 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 were expected to exhale for at least 6 seconds. The test was terminated once adequate expiration was achieved. Among at least three properly performed consecutive trials, the highest value was recorded
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 18 Sep 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.
MERVE YILMAZ MENEK, PhD principal investigator
İstanbul Medipol university
ŞULE AYAN principal investigator
İstanbul 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 therapy+manual therapy and Conventional therapy+manual therapy+breathing exercises in people with Rotator Cuff Injuries, 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 18 Sep 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?
Pain evaluation (time frame: Baseline and 6 weeks). The study lists 4 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 18 Sep 2025.