Pillow Brace to Improve Sleep After Rotator Cuff Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the use of a Pillow Brace, a support splint with a cushion system, to reduce nighttime pain and improve sleep quality after arthroscopic rotator cuff repair. Participants are adults undergoing the procedure and must be able to understand and use the brace and participate in daily activities. The study compares two intervention approaches to see if the Pillow Brace provides better comfort and sleep outcomes than standard immobilization. Recruitment is in Paris at Clinique Jouvenet under the lead sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche. The trial aims to address gaps in postoperative pain management and sleep disruption that can hinder recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient undergoing arthroscopic rotator cuff repair surgery confirmed by clinical diagnosis and preoperative imaging tests.
* Patient able to understand the instructions for using the brace.
* Patient able to perform activities of daily living with or without a brace, ensuring proper use of the brace.
* Patient affiliated with or beneficiary of a social security system
* French speaking patient, having signed an informed consent form

Exclusion Criteria:

* Patient with an uncertain diagnosis
* Patient undergoing rotator cuff revision surgery.
* Patient with complex or surgical fractures of the shoulder, humerus, or ribs
* Patient with multiple fractures, open fractures, or those with pinning
* Patient who has undergone multiple surgeries in the last 6 months.
* Patient with shoulder pathologies unrelated to the rotator cuff, such as severe arthritis or capsulitis.
* Patient on long-term morphine treatment
* Patient with known allergies to splint materials
* Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative order
* Pregnant woman
* Patient hospitalized without consent
* Patient already enrolled and participating in another clinical study

Where it's running

• Clinique Jouvenet
  Paris, France Recruiting

Study contacts

• Study coordinator: Philippe NGUYEN, MD
• Email: philippe.nguyen.pro@gmail.com
• Phone: +33 6 86 40 82 84

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.