Duloxetine Improves Early Clinical Outcomes Including Range of Motion, Functional Scores, Pain, and Psychological Distress After Arthroscopic Rotator Cuff Repair in Patients With Anxiety or Depression: Prospective Randomized Controlled Trial.

Abstract

Anxiety and depression are known risk factors for poor prognosis after arthroscopic rotator cuff repair (ARCR). However, studies that examine relief of postoperative psychological distress in patients with anxiety and/or depression remain limited. To evaluate the effect of duloxetine on the clinical outcomes of ARCR for chronic rotator cuff tears in patients with anxiety and/or depression. Randomized controlled clinical trial; Level of evidence, 2. A total of 63 patients undergoing ARCR were enrolled and categorized into 3 groups based on Hospital Anxiety and Depression Scale (HADS) scores and the use of oral duloxetine: group A (anxiety <8 and depression <8, healthy psychological status; n = 20); group B (anxiety ≥8 and/or depression ≥8, psychological distress receiving duloxetine administration; n = 21); and group C (anxiety ≥8 and/or depression ≥8, psychological distress receiving no duloxetine treatment; n = 22). Duloxetine was administered orally from the evening of the surgery. The dosage was 30 mg/d for the first 2 weeks. After the adaptation period, the dosage was increased to 60 mg/d for 12 weeks. Primary outcome was active forward flexion at postoperative 3 months. Other functional outcomes, structural outcomes, analgesic consumption, and duloxetine-related side effects were assessed at postoperative 3, 6, and 12 months and annually thereafter. No severe adverse events related to duloxetine were observed. However, 16% (4/25) of patients in group B experienced nausea and vomiting after duloxetine administration. Although symptoms resolved completely after antiemetic intervention, the patients withdrew from the study due to the drug-related adverse event. In the first 3 months after surgery, group B showed better range of motion (ROM), better functional outcomes (American Shoulder and Elbow Surgeons Standardized Assessment Form [ASES] and Simple Shoulder Test [SST]), better anxiety scores, better pain scores, and less opioid consumption than did group C (all adjusted <i>P</i> < .05). These differences were not observed between groups A and B (all adjusted <i>P</i> > .05). Functional outcomes and retear rates did not differ among the 3 groups at later follow-up. Administration of duloxetine to ARCR patients with anxiety and/or depressive distress screened using HADS not only improved anxiety and distress but also enhanced active ROM, ASES, and SST in the first 3 months postoperatively, although 16% of patients experienced nausea and vomiting.