Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthros… (NCT06157229) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair
100 participantsStarted 2024-01-01
Plain-language summary
This study will compare functional outcomes after an arthroscopic Bankart repair between patients that underwent conventional arthroscopic Bankart repair rehabilitation, following the American Society of Shoulder and Elbow Therapists guideline and patients that underwent 'multifactorial approach training', which focusses on decreasing kinesiophobia and fear of recurrent dislocations.
The study population comprises patients who will undergo Arthroscopic Bankart Repair (ABR) after a traumatic anterior shoulder dislocation at Spaarne Gasthuis Haarlem/Hoofddorp, OLVG Amsterdam, Amstelland Ziekenhuis Amstelveen, Gelre Ziekenhuizen, Medisch Spectrum Twente, or Flevoziekenhuis Almere.
Who can participate
Age range
18 Years – 67 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:
* Primary or recurrent traumatic anterior shoulder dislocation (MRI-confirmed labral tear)
* Aged between 18-67 years
* Planned arthroscopic Bankart repair (ABR) surgery
* Understanding of spoken and written Dutch language
* Written informed consent (according to the ICH-GCP guidelines)
* Positive apprehension sign at physical examination
Exclusion Criteria:
* Posterior or multidirectional shoulder instability
* Presence of hyperlaxity of the upper extremity and absence of sulcus sign and \>85 degrees of external rotation with the arm at the side at physical examination
* Connective tissue disorders (e.g. Ehlers-Danlos)
* Aged \<18 or \>67 years
* Assymetry in rotator cuff strength, bilateral component ((sub)luxations on contralateral side)
* History of soft tissue repair or bone block procedure on one of both shoulders
* Current or past anxiety disorders or use of anxiety supressing drugs (e.g. anti-psychotics)
* Implantable cardioverter defibrillator (ICD) (unable to be included for functional MRI)
* Neurological disorders or systemic disease
* Loss of anteroinferior sclerotic contour of the glenoid on AP view of the shoulder
* Hill-Sachs lesion visible on external rotation radiographs
* Greater tubercle fracture
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
Shoulder Instability Return to Sport Index (SIRSI)