The Effect of Body Awareness Level on Shoulder Functionality and Psychological Factors in Rotator Cuff Pathologies

NCT06797232 | Completed

• 1 other identifier: ozlemgorgulugoksu
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rotator Cuff Syndrome

Keywords

Body Awareness Body İmage Rotator cuff Mental health

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

Study Arms (2)

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."

Eligibility Criteria

• Age: 30 Days - 65 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Özlem Görgülü Göksu

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

Study Officials

• Gülay Aras Bayram, PhD

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, Msc

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 22, 2025
• Primary Completion: April 28, 2025
• Study Completion: June 19, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)