Understanding why some asymptomatic rotator cuff tears become painful.
Why do Asymptomatic Rotator Cuff Tears Become Painful? Effect of Biomechanical, Psychosocial and Painrelated Factors.
This study looks at people over 55 with rotator cuff tears that don’t hurt to see what might cause them to start having pain over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 207 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT05896475 on ClinicalTrials.gov |
What this trial studies
This observational study follows individuals over 55 years old with asymptomatic rotator cuff tears for two years to identify risk factors that may lead to the development of symptoms. Participants will undergo various assessments every three months, including pain measurements, biomechanical evaluations, and psychosocial questionnaires. The goal is to uncover the underlying factors that contribute to the transition from asymptomatic to symptomatic rotator cuff tears, which could inform early clinical interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older with asymptomatic rotator cuff tears diagnosed via ultrasound.
Not a fit: Patients with recent shoulder trauma, significant shoulder complaints, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing symptomatic rotator cuff tears in at-risk patients.
How similar studies have performed: While the approach of identifying risk factors for asymptomatic conditions is common, this specific study's focus on rotator cuff tears is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ghent, Oost-Vlaanderen
- Department of rehabilitation sciences — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Alexander Van Tongel, Prof. dr. — Orthopaedics and Traumatology Ghent University Hospital
- Study coordinator: Dorien Borms, dr.
- Email: dorien.borms@ugent.be
- Phone: +32 9 332 26 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.