Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic. (NCT05896475) | Clinical Trial Compass
RecruitingNot Applicable
Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.
Belgium207 participantsStarted 2023-06-02
Plain-language 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).
Who can participate
Age range
55 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pressure Pain Thresholds (PPT)
Timeframe: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
2
Acromiohumeral distance (AHD)
Timeframe: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic