Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears. Basic parameters: 55 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Why do Asymptomatic Rotator Cuff Tears Become Painful? Effect of Biomechanical, Psychosocial and Painrelated Factors.
Overview
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).
Detailed description
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.
Primary outcome measures
- Pressure Pain Thresholds (PPT) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Acromiohumeral distance (AHD) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
Secondary outcome measures (12)
- Clinical tests - mobility [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Clinical test - strength [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Conditioned Pain Modulation (CPM) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Central Sensitization Inventory (CSI) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Tampa Scale for Kinesiophobia (TSK) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Short Form-36 (SF-36) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Shoulder Pain and Disability Index (SPADI) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Depression, anxiety and stress scale (DASS-21) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- International Physical Activity Questionnaire (IPAQ) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Insomnia Severity Index (ISI) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- General Self-Efficacy Scale (GSES) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
- Electromyographic activity (EMG) [Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Department of rehabilitation sciences — Ghent
Identifiers
NCT: NCT05896475 · ONZ-2023-0062 · BOF22/DOC/005