Rotator Cuff SyndromeNCT06797232
The Effect of Body Awareness Level on Shoulder Functionality and Psychological Factors in Rotator Cuff Pathologies
An observational study of Rotator Cuff Syndrome, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Rotator cuff syndrome is a prevalent musculoskeletal condition and the most common cause of shoulder pain. It typically begins with tendonitis and may progress to partial or complete tendon rupture due to subacromial space narrowing or overuse. Read more about this study
- Who is it for?
- Ages 30 to 65 daysHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Syndrome
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Feb 2025to 19 Jun 2025
- How long will I take part?
- 50 Days
- Phase
- Observational
- 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 30 to 65 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 20 participants aged 30-65 years with rotator cuff tendinopathy who meet the inclusion criteria, along with 25 healthy volunteers of the same age and gender, will be included.
Who may be able to join
- Diagnosis of partial supraspinatus rupture by an orthopedics and traumatology specialist
- Shoulder pain lasting more than 4 weeks
- Unilateral shoulder pain,
- Not having been previously included in any physiotherapy program due to a shoulder problem,
- Body mass index (BMI) ≤ 30 kg/m²
- Individuals being cooperative
Show all 9Show fewer
- Individuals between the ages of 30-65
- Healthy volunteer participants
- Participants of the same age and gender
Who cannot join
- Having had shoulder surgery before,
- Receiving local corticosteroid injection/corticosteroid treatment within the last three months,
- Presence of uncontrolled neurological, cardiac, systemic disease that will prevent function,
- Presence of disease that will affect the cognitive and visual systems.
- Presence of shoulder pain in the last 6 months
- Pain in 90° shoulder abduction and flexion
Show all 9Show fewer
- Presence of night pain in the shoulder
- Having a body mass index (BMI) >30 kg/m2
- Having any systemic, neurological or rheumatological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Effect of Body Awareness Level on Shoulder Functionality and Psychological Factors in Rotator Cuff Pathologies"
Rotator cuff syndrome is a prevalent musculoskeletal condition and the most common cause of shoulder pain. It typically begins with tendonitis and may progress to partial or complete tendon rupture due to subacromial space narrowing or overuse. Its incidence increases with age and is more common in women, often resulting in significant functional loss, reduced shoulder mobility, and lower quality of life. Shoulder pain leads to limitations in daily activities and can trigger kinesiophobia, or fear of movement, further exacerbating physical and psychological impairments.
In addition to physical limitations, individuals with rotator cuff syndrome often experience psychological challenges such as stress, anxiety, and depression. Psychological resilience-a factor influencing general well-being-plays a critical role in coping with chronic pain. High psychological resilience is associated with reduced pain severity, better shoulder functionality, and lower levels of kinesiophobia. Kinesiophobia, in turn, can lead to movement avoidance, muscle disuse, and further deterioration in function.
Read more
Basic body awareness (BBA), defined through both experiential and movement dimensions, involves understanding how the body functions and interacts with the environment. It is shaped by multiple sensory systems including proprioception, interoception, and exteroception. Body awareness is linked to pain perception, functional movement, and health-related quality of life.
Although BBA has been studied in stroke, mental health, and chronic pain, its role in shoulder rehabilitation has not been sufficiently explored. This study aims to investigate the relationship between basic body awareness, shoulder functionality, and psychological factors in individuals with rotator cuff syndrome.
Read the detailed description
Rotator cuff syndrome is one of the musculoskeletal system disorders that covers a wide area. It is the most common cause of shoulder pain. The acute process begins with tendonitis of the tendons and can lead to partial rupture, degenerative changes, and eventually complete rupture. Its etiology is multifactorial, with the narrowing of the subacromial space or excessive use of the tendon being the main mechanisms. The lifetime incidence of shoulder pain observed in the general population is reported to be 67%, occurring more frequently in women than in men. Aging or other factors may be related to intrinsic degeneration associated with tendinopathy. The frequency of occurrence increases with age, leading to significant social participation and healthcare costs.
Shoulder pain and progressively increasing restriction of shoulder joint movement cause a reduction in shoulder joint positional awareness, upper extremity function, and quality of life. Losses in shoulder function affect individuals in many daily life skills, especially activities of daily living. The pain phenomenon that occurs during shoulder movements is the primary reason for these losses. Following this pain phenomenon, fear of movement or avoidance of movement may occur, leading to kinesiophobia.
In individuals with rotator cuff syndrome, there are not only functional impairments but also psychological impairments. The concept of "Psychological Resilience," which is among the psychological factors, is known to affect overall well-being. Especially in cases of persistent chronic shoulder pain, thoughts such as hopelessness and stress have a significant impact on psychosocial status. Psychosocial factors are thought to be quite effective in the severity of patients' pain and restrictions in joint range of motion. The literature indicates that individuals with high musculoskeletal pain have a high prevalence of anxiety and depression, particularly in chronic pain patients, and that psychological factors should be addressed.
The fear of movement and injury created by kinesiophobia is often followed by movement disorders and depression. It has been reported that individuals with high levels of kinesiophobia will avoid movement due to expecting the disease's course to worsen or for new symptoms to arise. Excessive avoidance of movement will lead to physical limitations in the individual's daily life. Consequently, a reduction in the patient's functionality will be observed. High psychological resilience has been found to be associated with lower pain severity, reduced joint limitations, and lower levels of kinesiophobia.
In physiotherapy, the dual definition of basic body awareness has been made. The first is the experience of the body (experiential dimension), and the second is movements and behaviors (movement dimension). In the context of physiotherapy, another definition of body awareness is the awareness of how the body is used in terms of its function, behavior, self, and interaction with others. Various sensory systems such as proprioception, interoception, exteroception, and the vestibular system are significant in the foundation of body awareness. For body awareness, the processing of interoceptive (sensory inputs coming from within the body) and exteroceptive (processing of inputs coming from outside the body) senses is necessary. Individuals' body awareness is related to movement capacity in daily life activities, health-related quality of life, body image, and pain severity findings.
While chronic basic body awareness has been studied in conditions like mental health, stroke, and chronic musculoskeletal problems, there are no studies examining basic body awareness in shoulder rehabilitation. Considering that psychological factors also affect the etiology of shoulder pain, our study aims to investigate the effect of basic body awareness level on shoulder functionality and psychological factors.
- Conditions
- Rotator Cuff Syndrome
- Keywords
- Body Awareness Body İmage Rotator cuff Mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Cuff Group | "A total of 25 participants aged 30-65 years with rotator cuff tendinopathy who meet the inclusion criteria, along with 25 healthy volunteers of the same age and gender, will be included." | |
| Healthy Group | "A total of 25 participants aged 30-65 years with rotator cuff tendinopathy who meet the inclusion criteria, along with 25 healthy volunteers of the same age and gender, will be included." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Pain Severity rated their feelings of pain on the line by themselves, thereby quantifying the pain.sual Analogue Scale Participants pain intensities ranged from "0" (no pain) to "10" (unbearable pain) to 10 cm will be evaluated with the Visual Pain Scale. The pain intensity of the participants before and after the treatment was evaluated at rest and during activity.
Measured: Baseline
Evaluation of joint range of motion
Baseline digital Absolute + Axis goniometer device will be used. Flexion, extension, abduction, internal and external rotation range of motion of the shoulder joint will be evaluated in degrees. For each joint range of motion value, 3 consecutive measurements will be taken and the average value will be recorded.
Measured: Baseline
American Shoulder and Elbow Surgeons (ASES)
American Shoulder and Elbow Surgeons (ASES) created the ASES questionnaire in order to develop a standardized method for evaluating shoulder function. The goal was to design a questionnaire that was easy to use, assessed function, and was entirely based on patient self-evaluation. The ASES score totals 100 points and allocates 50 points for measuring function and 50 points for pain.
Measured: Baseline
Body Awareness Questionnaire
The body awareness questionnaire is a 18 item scale, with the total scale score calculated as a sum of the items.
Items are scored on a 1-7 scale, with the total scale score calculated as a sum of the items. The questions with asterisks are reverse scored. This means that for example, if someone scored 1 it would now be a score of 5.
Measured: Baseline
Body Image Survey (BIA)
BIA was used to measure the patients' level of satisfaction with their body image. BIA consists of a person's body parts or functions.It is a scale that determines satisfaction. It was shown in the study by Hovardaoğlu et al. that the scale is valid and reliable in Turkish.
Measured: Baseline
Rotator Cuff Quality of Life
It is a questionnaire that evaluates the quality of life in rotator cuff injuries. It is a disease-specific questionnaire and is distinctive in assessing quality of life. It is a questionnaire consisting of 34 questions and 5 subparameters that evaluates the physical symptoms of the disease, work activities, daily living activities, social and emotional status. Each question is calculated out of 100 points and the total score is expressed as a percentage.
Measured: Baseline
The Tampa Scale for Kinesiophobia (TSK)
The Tampa Scale for Kinesiophobia (TSK) is a self-report questionnaire that is used to assess an individual's fear of movement or re-injury. The TSK consists of 17 items that ask respondents to rate their level of agreement with statements related to the fear of movement or re-injury. A high score from the scale indicates a high level of kinesiophobia.
Measured: Baseline
Assessment of Anxiety and Depression
The participants' anxiety and depression levels will be assessed with the Hospital Anxiety and Depression Scale.The scale was developed by Zigmond and Snaith to assess anxiety and depression levels. 7 of the 14 questions assess anxiety and 7 assess depression. Each item is scored between 0 and 3. High scores obtained from the scale indicate high anxiety and depression levels.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start22 Feb 2025
- Primary completion28 Apr 2025
- Study completion19 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 50 Days
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Gorgulu Goksu, Medipol University
- Investigators
- Gülay Aras Bayram, PhD, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797232
- Sponsor's protocol ID
- ozlemgorgulugoksu
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Body Awareness Level on Shoulder Functionality and Psychological Factors in Rotator Cuff Pathologies"
- ClinicalTrials.gov ID
- NCT06797232
- Acronym / sponsor ID
- ozlemgorgulugoksu
- Conditions
- Rotator Cuff Syndrome
- Keywords
- Body Awareness Body İmage Rotator cuff Mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 28 Jan 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 syndrome is a prevalent musculoskeletal condition and the most common cause of shoulder pain. It typically begins with tendonitis and may progress to partial or complete tendon rupture due to subacromial space narrowing or overuse. Its incidence increases with age and is more common in women, often resulting in significant functional loss, reduced shoulder mobility, and lower quality of life. Shoulder pain leads to limitations in daily activities and can trigger kinesiophobia, or fear of movement, further exacerbating physical and psychological impairments.
In addition to physical limitations, individuals with rotator cuff syndrome often experience psychological challenges such as stress, anxiety, and depression. Psychological resilience-a factor influencing general well-being-plays a critical role in coping with chronic pain. High psychological resilience is associated with reduced pain severity, better shoulder functionality, and lower levels of kinesiophobia. Kinesiophobia, in turn, can lead to movement avoidance, muscle disuse, and further deterioration in function.
Basic body awareness (BBA), defined through both experiential and movement dimensions, involves understanding how the body functions and interacts with the environment. It is shaped by multiple sensory systems including proprioception, interoception, and exteroception. Body awareness is linked to pain perception, functional movement, and health-related quality of life.
Although BBA has been studied in stroke, mental health, and chronic pain, its role in shoulder rehabilitation has not been sufficiently explored. This study aims to investigate the relationship between basic body awareness, shoulder functionality, and psychological factors in individuals with rotator cuff syndrome.
Detailed description
Rotator cuff syndrome is one of the musculoskeletal system disorders that covers a wide area. It is the most common cause of shoulder pain. The acute process begins with tendonitis of the tendons and can lead to partial rupture, degenerative changes, and eventually complete rupture. Its etiology is multifactorial, with the narrowing of the subacromial space or excessive use of the tendon being the main mechanisms. The lifetime incidence of shoulder pain observed in the general population is reported to be 67%, occurring more frequently in women than in men. Aging or other factors may be related to intrinsic degeneration associated with tendinopathy. The frequency of occurrence increases with age, leading to significant social participation and healthcare costs.
Shoulder pain and progressively increasing restriction of shoulder joint movement cause a reduction in shoulder joint positional awareness, upper extremity function, and quality of life. Losses in shoulder function affect individuals in many daily life skills, especially activities of daily living. The pain phenomenon that occurs during shoulder movements is the primary reason for these losses. Following this pain phenomenon, fear of movement or avoidance of movement may occur, leading to kinesiophobia.
In individuals with rotator cuff syndrome, there are not only functional impairments but also psychological impairments. The concept of "Psychological Resilience," which is among the psychological factors, is known to affect overall well-being. Especially in cases of persistent chronic shoulder pain, thoughts such as hopelessness and stress have a significant impact on psychosocial status. Psychosocial factors are thought to be quite effective in the severity of patients' pain and restrictions in joint range of motion. The literature indicates that individuals with high musculoskeletal pain have a high prevalence of anxiety and depression, particularly in chronic pain patients, and that psychological factors should be addressed.
The fear of movement and injury created by kinesiophobia is often followed by movement disorders and depression. It has been reported that individuals with high levels of kinesiophobia will avoid movement due to expecting the disease's course to worsen or for new symptoms to arise. Excessive avoidance of movement will lead to physical limitations in the individual's daily life. Consequently, a reduction in the patient's functionality will be observed. High psychological resilience has been found to be associated with lower pain severity, reduced joint limitations, and lower levels of kinesiophobia.
In physiotherapy, the dual definition of basic body awareness has been made. The first is the experience of the body (experiential dimension), and the second is movements and behaviors (movement dimension). In the context of physiotherapy, another definition of body awareness is the awareness of how the body is used in terms of its function, behavior, self, and interaction with others. Various sensory systems such as proprioception, interoception, exteroception, and the vestibular system are significant in the foundation of body awareness. For body awareness, the processing of interoceptive (sensory inputs coming from within the body) and exteroceptive (processing of inputs coming from outside the body) senses is necessary. Individuals' body awareness is related to movement capacity in daily life activities, health-related quality of life, body image, and pain severity findings.
While chronic basic body awareness has been studied in conditions like mental health, stroke, and chronic musculoskeletal problems, there are no studies examining basic body awareness in shoulder rehabilitation. Considering that psychological factors also affect the etiology of shoulder pain, our study aims to investigate the effect of basic body awareness level on shoulder functionality and psychological factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 50 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator Cuff Group | – | –"A total of 25 participants aged 30-65 years with rotator cuff tendinopathy who meet the inclusion criteria, along with 25 healthy volunteers of the same age and gender, will be included." |
| Healthy Group | – | –"A total of 25 participants aged 30-65 years with rotator cuff tendinopathy who meet the inclusion criteria, along with 25 healthy volunteers of the same age and gender, will be included." |
Who may qualify
- Ages
- 30 to 65 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 20 participants aged 30-65 years with rotator cuff tendinopathy who meet the inclusion criteria, along with 25 healthy volunteers of the same age and gender, will be included.
Key inclusion criteria (9 listed)
- Diagnosis of partial supraspinatus rupture by an orthopedics and traumatology specialist
- Shoulder pain lasting more than 4 weeks
- Unilateral shoulder pain,
- Not having been previously included in any physiotherapy program due to a shoulder problem,
- Body mass index (BMI) ≤ 30 kg/m²
Key exclusion criteria (9 listed)
- Having had shoulder surgery before,
- Receiving local corticosteroid injection/corticosteroid treatment within the last three months,
- Presence of uncontrolled neurological, cardiac, systemic disease that will prevent function,
- Presence of disease that will affect the cognitive and visual systems.
- Presence of shoulder pain in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Severity
Time frame: Baseline
Pain Severity rated their feelings of pain on the line by themselves, thereby quantifying the pain.sual Analogue Scale Participants pain intensities ranged from "0" (no pain) to "10" (unbearable pain) to 10 cm will be evaluated with the Visual Pain Scale. The pain intensity of the participants before and after the treatment was evaluated at rest and during activity.
Evaluation of joint range of motion
Time frame: Baseline
Baseline digital Absolute + Axis goniometer device will be used. Flexion, extension, abduction, internal and external rotation range of motion of the shoulder joint will be evaluated in degrees. For each joint range of motion value, 3 consecutive measurements will be taken and the average value will be recorded.
American Shoulder and Elbow Surgeons (ASES)
Time frame: Baseline
American Shoulder and Elbow Surgeons (ASES) created the ASES questionnaire in order to develop a standardized method for evaluating shoulder function. The goal was to design a questionnaire that was easy to use, assessed function, and was entirely based on patient self-evaluation. The ASES score totals 100 points and allocates 50 points for measuring function and 50 points for pain.
Body Awareness Questionnaire
Time frame: Baseline
The body awareness questionnaire is a 18 item scale, with the total scale score calculated as a sum of the items. Items are scored on a 1-7 scale, with the total scale score calculated as a sum of the items. The questions with asterisks are reverse scored. This means that for example, if someone scored 1 it would now be a score of 5.
Body Image Survey (BIA)
Time frame: Baseline
BIA was used to measure the patients' level of satisfaction with their body image. BIA consists of a person's body parts or functions.It is a scale that determines satisfaction. It was shown in the study by Hovardaoğlu et al. that the scale is valid and reliable in Turkish.
Rotator Cuff Quality of Life
Time frame: Baseline
It is a questionnaire that evaluates the quality of life in rotator cuff injuries. It is a disease-specific questionnaire and is distinctive in assessing quality of life. It is a questionnaire consisting of 34 questions and 5 subparameters that evaluates the physical symptoms of the disease, work activities, daily living activities, social and emotional status. Each question is calculated out of 100 points and the total score is expressed as a percentage.
The Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline
The Tampa Scale for Kinesiophobia (TSK) is a self-report questionnaire that is used to assess an individual's fear of movement or re-injury. The TSK consists of 17 items that ask respondents to rate their level of agreement with statements related to the fear of movement or re-injury. A high score from the scale indicates a high level of kinesiophobia.
Assessment of Anxiety and Depression
Time frame: Baseline
The participants' anxiety and depression levels will be assessed with the Hospital Anxiety and Depression Scale.The scale was developed by Zigmond and Snaith to assess anxiety and depression levels. 7 of the 14 questions assess anxiety and 7 assess depression. Each item is scored between 0 and 3. High scores obtained from the scale indicate high anxiety and depression levels.
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 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Gülay Aras Bayram, PhD study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Syndrome, run by Medipol 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 9 inclusion and 9 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 Jun 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 Severity (time frame: Baseline). The study lists 8 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 Jun 2025.