NCT05896475 Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.
| NCT ID | NCT05896475 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Rotator Cuff Tears |
| Study Type | OBSERVATIONAL |
| Enrollment | 207 participants |
| Start Date | 2023-06-02 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 207 participants in total. It began in 2023-06-02 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Alexander Van Tongel, Prof. dr.
PRINCIPAL INVESTIGATOR
Orthopaedics and Traumatology Ghent University Hospital
Frequently Asked Questions
Who can join the NCT05896475 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 100 Years, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05896475 currently recruiting?
Yes, NCT05896475 is actively recruiting participants. Contact the research team at dorien.borms@ugent.be for enrollment information.
Where is the NCT05896475 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT05896475 clinical trial?
NCT05896475 is sponsored by University Ghent. The principal investigator is Alexander Van Tongel, Prof. dr. at Orthopaedics and Traumatology Ghent University Hospital. The trial plans to enroll 207 participants.