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Effects of Melatonin on Sleep Quality following Arthroscopic Rotator Cuff Surgery: A Prospective, Randomized Controlled Trial

Henson Destiné, A. Hall, Rahul Muchintala, Matthew Pepe, Bradford S. Tucker, Fotios P. Tjoumakaris, Andres R. Perez

Orthopaedic Journal of Sports Medicine, 2025

Abstract

Objectives: Sleep disturbance is a significant symptom associated with both rotator cuff tears and arthroscopic rotator cuff repair. Melatonin has been shown to be safe and effective in managing multiple sleep disorders, including secondary sleep disorders, with relatively minor adverse effects, and lack of addictive potential. The purpose of this study was to investigate the effects of oral melatonin on postoperative sleep quality after arthroscopic rotator cuff repair (aRCR). Methods: This was a prospective, randomized, clinical trial evaluating patients undergoing arthroscopic rotator cuff repair. Consecutive patients undergoing arthroscopic rotator cuff repair for rotator cuff tear were included. Exclusion criteria included history of alcohol abuse, current antidepressant or sedative use, revision rotator cuff repair, severe glenohumeral arthritis, and concurrent adhesive capsulitis. Patients were randomly assigned in a 1:1 ratio to one of two groups: 5 mg dose of melatonin 1 hour before bedtime, or standard sleep hygiene (6+ hours per night, avoid caffeine and naps in the evening). Patients in the melatonin group took their assigned melatonin dose for 6 weeks beginning the day of surgery. Patient reported outcome assessments included the Pittsburgh Sleep Quality Index (PSQI), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Single Assessment Numerical Evaluation (SANE), and pain medication logs. Outcome measures were collected…

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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.

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