Effects of Melatonin on Sleep Quality and Patient-Reported Outcomes After Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial
Abstract
Background: 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. Purpose: To investigate the effects of oral melatonin on postoperative sleep quality after arthroscopic rotator cuff repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This was a prospective randomized clinical trial evaluating patients undergoing arthroscopic rotator cuff repair. 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 1 of 2 groups: 5-mg dose of melatonin 1 hour before bedtime or standard sleep hygiene (≥6 hours per night, avoiding 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, including the Pittsburgh Sleep Quality Index (PSQI), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), and the Single Assessment Numeric Evaluation (SANE), and pain medication charts were collected preoperatively as well as at 2 weeks, 6 weeks, 3 months, 4 months, and 6 months…
How strong is the evidence?
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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