Disclosures: Jeremiah F. Ling: No financial relationships or conflicts of interest

Background and/or Objectives: The purpose of this analysis was to develop a comprehensive, systematic review of randomized placebo-controlled trials in the current literature that investigates duloxetine for the treatment of chronic low back pain (CLBP). We hypothesized that duloxetine is a safe and effective pharmacological intervention for the treatment of CLBP.

Design: All level I and II randomized controlled studies published in the English language investigating the efficacy of duloxetine for chronic low back pain were included.

Setting: Five studies were analyzed.

Participants: These five studies contained: 1540 patients treated with (i) duloxetine (832 patients), (ii) placebo (667 patients), or (iii) both duloxetine and placebo in a crossover analysis (41 patients). All studies excluded patients with concomitant MDD.

Interventions: All studies used dosages of Duloxetine ranging from 20 to 120 mg.

Main Outcome Measures: Five studies containing 785 duloxetine patients (94.4%), 628 placebo patients (94.2%), and 25 crossover patients (61.0%) reported efficacy outcomes during the trial. Four studies reported outcome scores including Brief Pain Inventory-Severity (BPI-S) scale, Brief Pain Inventory-Improvement (BPI-I) scale, Clinical Global Impressions of Severity (CGI-S), short-form 36 (SF-36), and Roland-Morris Disability Questionnaire (RMDQ-24). All five studies reported statistically significant improvements in more than one back-pain-specific clinical outcome score with duloxetine versus placebo.

Results: All five studies reported statistically significant improvements in more than one back-pain-specific clinical outcome score with duloxetine versus placebo. Four studies found that duloxetine 60 mg daily leads to one or more statistically significant improvements versus placebo in Brief Pain Inventory Severity (BPI-S) scores. All five studies found no significant difference in serious adverse events (AEs) between duloxetine and placebo groups.

Conclusions: Duloxetine is a safe and effective first line option for the treatment of CLBP. Current studies demonstrate that 60 mg taken once daily has the highest efficacy for reducing pain and disability while minimizing minor adverse effects.

Level of Evidence: Level II

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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/duloxetine-for-the-treatment-of-chronic-low-back-pain-a-systematic-review-of-randomized-placebo-controlled-trials/