NCT07636941

Brief Summary

This study aims to investigate the relationship between thoracic kyphosis angle, trunk rotation mobility, and balance performance in individuals with rotator cuff pathology. The rotator cuff, consisting of the supraspinatus, infraspinatus, teres minor, and subscapularis muscles, plays a crucial role in providing both static and dynamic stability to the shoulder joint. Rotator cuff pathologies are among the most common causes of shoulder pain and functional limitation, with their prevalence increasing with age. Although shoulder pain has traditionally been considered a localized musculoskeletal problem, recent biomechanical evidence highlights the importance of the kinetic chain concept, which emphasizes the interconnected function of the upper extremity with the lower extremity, thoracic spine, and postural control mechanisms. Within this framework, thoracic spine mobility and postural stability are considered key factors in preventing pathological loading on the rotator cuff tendons. The thoracic spine serves as a fundamental biomechanical platform for scapulothoracic joint function. Increased thoracic kyphosis has been shown to negatively affect scapular upward rotation and posterior tilt during humeral elevation, contributing to narrowing of the subacromial space and increased mechanical stress on the rotator cuff tendons. In addition, trunk rotation mobility plays an essential role in efficient energy transfer along the kinetic chain, particularly during functional movements such as reaching or throwing. Limitations in trunk rotation may disrupt this energy transfer, resulting in compensatory loading of the shoulder complex and increased injury risk. Furthermore, kinesiophobia associated with chronic pain may alter movement strategies, reduce physical activity levels, contribute to muscle atrophy, and indirectly impair postural control mechanisms. Balance performance is maintained through the integration of visual, vestibular, and somatosensory systems. In individuals with rotator cuff pathology, impaired proprioceptive input from the shoulder girdle and increased pain-related postural sway may lead to decreased performance in dynamic balance tasks such as the Y-Balance Test. In contrast, in healthy individuals, postural control strategies have been shown to correlate with self-perception and body awareness levels. Based on this theoretical framework, the primary aim of the present study is to compare thoracic kyphosis angle, trunk rotation mobility, static balance, and dynamic balance performance between individuals with rotator cuff pathology and healthy controls, and to examine the relationships between these variables. It is hypothesized that individuals with rotator cuff pathology will demonstrate significant differences in these parameters compared to healthy individuals. The study will be conducted at the Physical Therapy Unit of Iğdır State Hospital and will include individuals aged 18-65 years. Sample size calculation was performed using G\*Power software based on a previously reported effect size (Cohen's d = 0.63) for thoracic kyphosis. With an alpha level of 0.05 and statistical power of 80%, at least 36 participants per group were required. To account for potential dropouts, a total of 80 participants will be included, consisting of at least 40 individuals with rotator cuff pathology and 40 healthy controls. All participants will provide written informed consent, and sociodemographic and clinical information will be collected through face-to-face interviews. Thoracic kyphosis angle will be measured using a smartphone-based digital inclinometer by calculating the angular difference between T1-T2 and T12-L1 vertebral levels. Trunk rotation range of motion will be assessed using a digital goniometer. Static balance performance will be evaluated using the Single Leg Stance Test under eyes-open and eyes-closed conditions. Dynamic balance performance will be assessed using the Y-Balance Test protocol, in which reach distances in three directions are normalized according to leg length. These measurement tools have been reported to demonstrate high validity and reliability in clinical research. In conclusion, this study seeks to demonstrate that rotator cuff pathology should not be considered solely a localized shoulder disorder but rather a condition associated with impairments in the kinetic chain, including thoracic spine mobility and postural control mechanisms. The findings are expected to highlight the importance of assessing thoracic mobility and balance performance in shoulder rehabilitation programs.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Apr 2026Oct 2026

Study Start

First participant enrolled

April 27, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 4, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

Kyphosis ThoracicThoracic VertebraePostural balanceRotator cuff injuries

Outcome Measures

Primary Outcomes (2)

  • Thoracic kyphosis angle

    Participants' thoracic kyphosis levels will be measured via a smartphone equipped with 'Angle Meter' software, a digital inclinometer, and calibrated gyroscope and accelerometer sensors.

    At baseline (single assessment)

  • Trunk rotation

    Trunk Active Range of Motion (ROM) will be assessed in a seated position using a digital goniometer.

    At baseline (single assessment)

Secondary Outcomes (3)

  • Static postural balance

    At baseline (single assessment)

  • Dynamic postural balance

    At baseline (single assessment)

  • Body awareness

    At baseline (single assessment)

Study Arms (2)

Control Group

Healthy individuals

Rotator Cuff Group

Individuals with rotator cuff injuries

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Rotator cuff pathology (impingement syndrome, tendinopathy, or partial tear)

You may qualify if:

  • Have been diagnosed with unilateral rotator cuff pathology (impingement syndrome, tendinopathy, or partial tear) by a specialist physician through clinical examination and/or radiological imaging (USG/MR);
  • have been between 18 and 65 years of age; have shoulder pain that has lasted for at least 3 months;
  • have a positive result on at least two of the Neer, Hawkins-Kennedy, and Empty Can tests;
  • have pain of at least 3/10 on the Pain Numerical Rating Scale (PMR) during rest or activity;
  • have sufficient cognitive ability to follow simple instructions and administer the tests; have a Mini Mental State Test score ≥24;
  • be able to provide signed informed consent and voluntarily agree to participate in the study.
  • No history of shoulder, neck, or upper back injury and no painful symptoms reported in any of these areas within the last 12 months,
  • negative shoulder-specific tests (Neer, Hawkins, etc.), full range of motion on physical examination, and cognitive capacity to perform the tests.

You may not qualify if:

  • Having undergone previous surgery in the shoulder or thoracic region;
  • Full-thickness rotator cuff tears requiring surgical indication; adhesive capsulitis, shoulder instability, labrum tears, or calcific tendinitis;
  • cervical radiculopathy or neurological diseases affecting the upper and lower extremities;
  • uncontrolled diabetes, inflammatory rheumatic diseases (rheumatoid arthritis, etc.), or malignancy;
  • severe osteoporosis in the thoracic region, structural scoliosis or advanced postural deformity that may affect trunk rotation, unstable vertebral fractures, or active infection;
  • having received steroid (cortisone) or PRP injections in the shoulder region within the last 3 months;
  • vestibular or visual impairment, those using medications that may affect balance, those with a lower extremity injury within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 9, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations