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Pillow Brace Assessment on Sleep Quality of Patients Undergoing Arthroscopic Rotator Cuff Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Rotator cuff surgery is an increasingly popular procedure in France. It is a common procedure for patients with shoulder tendon injuries, aimed at restoring mobility and reducing pain. Although arthroscopic techniques have improved functional outcomes, managing postoperative pain, particularly at night, and its consequences remains a major challenge. Studies highlight that postoperative nighttime pain can significantly affect sleep quality, delaying functional recovery and patient satisfaction. However, standard splints used for postoperative immobilization do not offer an optimal solution to this problem, leaving a significant gap in the care of these patients. Given this observation, a splint incorporating a support cushion system could meet the specific needs expressed by patients who have undergone rotator cuff surgery, namely improving sleep quality by minimizing nighttime pain. This splint, called the Pillow Brace, was developed internally at the Jouvenet Clinic. It therefore does not have CE marking. Nevertheless, this study is based on the hypothesis that the use of a Pillow Brace could significantly improve sleep quality compared to standard splints, thus making a significant contribution to orthopedic medicine, postoperative rehabilitation, and patient quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Clinique Jouvenet
RECRUITING
Paris
Contact Information
Primary
Philippe NGUYEN, MD
philippe.nguyen.pro@gmail.com
+33 6 86 40 82 84
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
Experimental: Pillow Brace
The Pillow Brace arm will consist of a Dujarrier-type splint to which a deformable cushion will be fixed
Other: Standard
The Standard arm will consist of a Dujarrier-type splint
Related Therapeutic Areas
Sponsors
Leads: GCS Ramsay Santé pour l'Enseignement et la Recherche

This content was sourced from clinicaltrials.gov