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

Background:

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.

Purpose:

To evaluate the effect of duloxetine on the clinical outcomes of ARCR for chronic rotator cuff tears in patients with anxiety and/or depression.

Study Design:

Randomized controlled clinical trial; Level of evidence, 2.

Method:

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.

Results:

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 P < .05). These differences were not observed between groups A and B (all adjusted P > .05). Functional outcomes and retear rates did not differ among the 3 groups at later follow-up.

Conclusion:

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.