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NCT Number: NCT05896475

Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.

In this prospective study, subjects older than 55 years with a degenerative asymptomatic rotator cuff tears will be followed for a period of 2 years. After testing, a symptom registration form will be filled in every 3 months. The test moment consists of pain measurements (pain pressure thresholds and conditioned pain modulation), biomechanical measurements (strength (including hand grip strength), range of motion, ultrasound (while measuring electromyographic activity) and shear wave elastography) and psychosocial measurements (psychosocial questionnaires).

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Key information

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

In this prospective study, the aim is to determine the risk factors for developing a symptomatic rotator cuff (RC) tear. It is still unknown why some patients with a RC tear develop complaints and others do not. Better understanding of the etiological factors that underlie RC pathology will increase the efficacy of early clinical intervention. A prospective study with a minimum of 2 year follow-up will be conducted. Biomechanical, psychosocial and painrelated factors will be screened as possible risk factors. We hypothesize that negative psychosocial factors and biomechanical impairments will be risk factors for an asymptomatic tear to become symptomatic over time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 55+ years old
  • male or female
  • asymptomatic rotator cuff tear diagnosed with ultrasound by a medical doctor
  • mean visual analogue score (VAS) of < 3 during daily life activities
  • no shoulder complaints having a significant influence on daily life activities

Exclusion criteria

  • recent shoulder trauma
  • massive rotator cuff tears
  • small partial thickness tears
  • neck complaints
  • history of shoulder surgery
  • history of proximal upper arm fracture
  • frozen shoulder
  • inflammatory arthritis
  • peripheral or central disorders
  • cognitive disorders

Treatment and study plan

Primary outcomes

  1. Pressure Pain Thresholds (PPT)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    PPTs will be measured on three local locations around the shoulder (supraspinatus, infraspinatus and posterior deltoid). Additionally, two more distal PPTs will be measured (erector spinae and triceps surae).

  2. Acromiohumeral distance (AHD)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The AHD is the shortest linear distance between the inferior edge of the acromion and the superior edge of the humeral head. This will be measured during rest and during muscle activity.

Secondary outcomes

  1. Clinical tests - mobility

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    Passive and active scaption - passive external rotation in supine position with arm in 90° abduction - passive internal rotation in supine position with arm in 90° abduction.

  2. Clinical test - strength

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    45° scapular elevation - external rotation - internal rotation - hand grip strength

  3. Conditioned Pain Modulation (CPM)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The conditioning stimulus will comprise of immersion of the foot until the proximal ankle (level of the malleoli) in a hot circulating water bath of 45.5°C during 1 minute. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) before and after completion of the conditioning stimulus.

  4. Central Sensitization Inventory (CSI)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The CSI measures the participant's Central Sensitization Syndrome related symptoms. The higher the score, the more signs of central sensitization are present.

  5. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The TSK evaluates the general pain related fear of movement. The higher the score, the higher the pain related fear.

  6. Short Form-36 (SF-36)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The SF-36 evaluates the general health and well-being or quality of life. Contains a physical and mental component score. A higher score expresses a better health condition.

  7. Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The SPADI evaluates the pain and restrictions in activities. The higher the score, the worse the symptoms.

  8. Depression, anxiety and stress scale (DASS-21)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    DASS-21 evaluates the depression (7 items); anxiety (7 items) and stress (7 items). The score will be multiplied by 2 to have a comparable score with the DASS-42.

  9. International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The IPAQ will be used to evaluate the physical activity level of the participants. This questionnaire contains 31 questions in 5 domains: 1) physical activity during work; 2) physical activity concerning transport; 3) physical activity by doing household chores; 4) physical activity concerning sport activities; 5) sitting time.

  10. Insomnia Severity Index (ISI)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    Seven questions to ask for sleep problems.

  11. General Self-Efficacy Scale (GSES)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The GSES measures (10 statements) how a person deals with stressors/difficult situations in life. The scale is about a person's self-confidence that his or her actions are responsible for successful outcomes or, in other words, that one has control over challenging demands imposed by the environment.

  12. Electromyographic activity (EMG)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    Electromyographic activity will be measured during AHD measurement in rest and during activity. The amplitude of the EMG activity from the three parts of the deltoid (anterior, middle and posterior part) will be obtained. The unit is volt. EMG activity will be expressed as percentage of the MVIC (maximal voluntary isometric contraction).

  13. Shear Wave Elastography (SWE)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    This is a non-invasive and real time assessment of tissue mechanical properties that measures the elasticity of the muscles/tendons. The higher the shear modulus/young modulus/shear wave speed, the higher the stiffness. SWE assessment will be done for the followings muscles: supraspinatus, infraspinatus, anterior and posterior deltoid.

  14. Supraspinatus muscle thickness

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The supraspinatus muscle thickness will be measured on two locations: 1) midpoint of the line cranial to the spina scapula; 2) 2 cm medial to the midpoint of the line cranial to the spina scapulae. One longitudinal and one transverse measurement at each of the scanning sites will be performed. This will be measured in mm.

  15. Humeral glenoid distance (HGD)

    Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

    The HGD is the distance between the most posterior point of the humeral head and the posterior glenoid. This will be measured in mm.

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Cools, Prof. dr.

CONTACT

[email protected]

+32 9 332 26 33

Dorien Borms, dr.

CONTACT

[email protected]

+32 9 332 26 34

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Why do Asymptomatic Rotator Cuff Tears Become Painful? Effect of Biomechanical, Psychosocial and Painrelated Factors.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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