Impact of Orthopedic Surgery on Workers' Sleep

Goal: The clinical investigation aims to evaluate the impact of orthopedic shoulder surgery on sleep quality and functional recovery in workers with shoulder musculoskeletal disorders. This will be assessed through validated questionnaires and physiological monitoring using wearable sensors. Participant Population: The study will enroll at least 30 participants diagnosed with shoulder musculoskeletal disorders, such as rotator cuff tears, adhesive capsulitis, and glenohumeral osteoarthritis. Participants must be employed in physically demanding jobs that require frequent upper limb activity and are scheduled for orthopedic shoulder surgery. Main Questions: * How does post-operative rehabilitation influence sleep quality and functional recovery in workers with shoulder musculoskeletal disorders? * To what extent does post-operative rehabilitation improve pain management and overall quality of life in these patients? * How do patients perceive the usability and comfort of wearable sensors during their rehabilitation process? Participant Tasks: * Initial Assessment: Comprehensive clinical evaluation, including demographic and anthropometric data collection, and administration of the Pittsburgh Sleep Quality Index (PSQI). * Wearable Sensor Training: Instruction on the proper use of the Medtronic Zephyr BioPatch™ wearable biosensor for monitoring physiological and postural signals. * Sleep Monitoring: Participants will undergo sleep assessments at three key time points: Two nights before surgery (baseline measurement); Two weeks post-surgery during early rehabilitation; 30 days into the rehabilitation program. * Daily Logging: Completion of the Consensus Sleep Diary each morning following sensor use. * Functional Assessment: Objective evaluation of shoulder functionality through validated clinical scales and range of motion (ROM) assessments. * Pain and Usability Evaluation: Measurement of pain reduction and usability of wearable technology using Patient-Reported Outcome Measures (PROMs).

NCT Number	NCT06854913
Lead Sponsor	Fondazione Policlinico Universitario Campus Bio-Medico
Conditions	Shoulder Musculoskeletal Disorders
Enrollment	30 participants
Start Date	2025-03-03
Primary Completion	2026-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-05-22