Clinical trial NCT06797232: The Effect of Body Awareness Level on Shoulder Functionality and Psychological Factors in Rotator Cuff Pathologies
Official title: "The Effect of Body Awareness Level on Shoulder Functionality and Psychological Factors in Rotator Cuff Pathologies"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Syndrome
Keywords: Body Awareness Body İmage Rotator cuff Mental health
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Inclusion Criteria for Healthy Volunteer Group

* Individuals between the ages of 30-65
* Healthy volunteer participants
* Participants of the same age and gender

Exclusion Criteria for Healthy Volunteer Group

* Presence of shoulder pain in the last 6 months
* Pain in 90° shoulder abduction and flexion
* Presence of night pain in the shoulder
* Having a body mass index (BMI) \>30 kg/m2
* Having any systemic, neurological or rheumatological disease

Primary outcomes:
measure: Pain Severity
timeFrame: Baseline
measure: Evaluation of joint range of motion
timeFrame: Baseline
measure: American Shoulder and Elbow Surgeons (ASES)
timeFrame: Baseline
measure: Body Awareness Questionnaire
timeFrame: Baseline
measure: Body Image Survey (BIA)
timeFrame: Baseline
measure: Rotator Cuff Quality of Life
timeFrame: Baseline
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline
measure: Assessment of Anxiety and Depression
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Özlem Görgülü Göksu
state: Beykoz
Study officials:
References: