1. Effects of Melatonin on Sleep Quality and Patient-Reported Outcomes After Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial.
- Author
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Perez AR, Destiné H, Patel NK, Campbell RE, Muchintala R, Hall AT, Pepe MD, Tucker BS, and Tjoumakaris FP
- Subjects
- Humans, Male, Middle Aged, Female, Prospective Studies, Aged, Adult, Melatonin administration & dosage, Melatonin therapeutic use, Arthroscopy, Patient Reported Outcome Measures, Sleep Quality, Rotator Cuff Injuries surgery
- 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 postoperatively. Numeric variables were analyzed using paired and unpaired t tests, with significance set at P < .05., Results: Eighty patients were included for final analysis (40 in the control group, 40 in the melatonin group). Patient characteristics such as age, sex, race, body mass index, and laterality did not differ significantly ( P ≥ .05). Preoperative ASES, SANE, and PSQI scores did not differ between groups ( P ≥ .055). PSQI scores were significantly lower (better quality sleep) in the melatonin group at the 6-week postoperative period ( P = .036). There was a positive correlation between how patients rated the intensity of their pain and the PSQI at the 6-week postoperative period (0.566). The PSQI question regarding sleep quality was found to be significantly lower in the melatonin group at the 3-month, 4-month, and 6-month postoperative periods ( P = .015, P = .041, and P ≤ .05, respectively). SANE scores were significantly lower in the melatonin group ( P = .011) at 6 weeks and then higher in the melatonin group ( P = .017) at 6 months. ASES scores were significantly higher in the melatonin group at 4 and 6 months ( P = .022 and P = .020, respectively). Lastly, patients who were randomized into the melatonin group were found to use significantly less narcotic medication at the 4-month postoperative period ( P = .046)., Conclusion: Melatonin use after arthroscopic rotator cuff repair led to improved sleep quality (PSQI) in the early postoperative period as well as improved functional outcomes (ASES and SANE scores) and decreased narcotic use in the later postoperative period. Patients with significant sleep disturbances associated with rotator cuff repairs may benefit from the use of melatonin., Registration: NCT04278677 (ClinicalTrials.gov identifier)., Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: N.K.P. has received a grant from DJO and support for education from Smith & Nephew, Paladin Technology Solutions, Eclipse Technology Solutions, and Mid-Atlantic Surgical Systems. R.E.C. has received support for education from Arthrex and Liberty Surgical Inc and hospitality payments from Stryker Corporation. B.S.T. has received research support from DePuy, GID, and Pacira; has received consulting fees from Mitek, DePuy, Pacira, and Medical Device Business Services; and holds stock or stock options in Johnson & Johnson. F.P.T. has received royalties from Tigon Medical; consulting fees from Medical Device Business Services and DePuy Synthes; and hospitality payments from Smith & Nephew and MicroVention; and holds stock or stock options in Trice Medical. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.
- Published
- 2024
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