Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy (NCT07658326) | Clinical Trial Compass
RecruitingNot Applicable
Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy
France100 participantsStarted 2023-09-28
Plain-language summary
Orthopedic surgery of the limbs presents a unpredictable postoperative course, which can be more or less lengthy in terms of functional recovery and resumption of personal or professional activities. Not uncommon, convalescence can require many months with dramatic personal and/or socio-professional consequences (disability, unemployment, etc.), particularly in the postoperative development of complex regional pain syndrome (CRPS) and/or adhesive capsulitis.
Among the suspected contributing factors, the existence of an unfavorable preoperative psychological context in patients is often mentioned.
This research is based on the hypothesis that a high level of preoperative stress in patients could contribute to the occurrence of more significant postoperative complications in patients who have undergone shoulder surgery.
The main objective is to measure the level of preoperative stress in patients undergoing surgery for rotator cuff tendinopathy.
Who can participate
Age range
18 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:
* Patient, male or female, over 18 years of age
* First-line surgery for rotator cuff tendinopathy (torn and untorn)
* Subject affiliated with or covered by a social security scheme
* Collection of the patient's non-opposition to participate in the study
Exclusion Criteria:
* Patients with medical history of adhesive capsulitis or complex regional pain syndrome (CRPS)
* Patients with a history of diabetes or thyroid dysfunction
* Patients with a history of fibromyalgia
* Patients with a history of mental illness (PMD, schizophrenia)
* Patients taking antidepressants or similar medications
* Patients participating in another clinical trial
* Protected patients: adults under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant, breastfeeding, or parturient women;
* Patients hospitalized without their consent.
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.