Duloxetine Versus Placebo in Patients With Chronic Low Back Pain: A 12-Week, Fixed-Dose, Randomized, Double-Blind Trial

[Justin]

The Journal of Pain. Volume 11, Issue 12, December 2010, Pages 1282-1290

Duloxetine Versus Placebo in Patients With Chronic Low Back Pain: A 12-Week, Fixed-Dose, Randomized, Double-Blind Trial

Vladimir Skljarevski*, Shuyu Zhang*, Durisala Desaiah*, Karla J. Alaka*, Santiago Palacios†, Tomasz Miazgowski‡ and Kyle Patrick§
† Palacios Institute, Madrid, Spain
‡ Pomeranian Medical University, Szczecin, Poland
* Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana
§ Dedicated Phase 1, Phoenix, Arizona
© 2010 American Pain Society Published by Elsevier Inc.

Abstract
This randomized, double-blind, placebo-controlled study assessed efficacy and safety of duloxetine in patients with chronic low back pain (CLBP). Adults (n = 401) with a nonneuropathic CLBP and average pain intensity of ≥4 on an 11-point numerical scale (Brief Pain Inventory [BPI]) were treated with either duloxetine 60 mg once daily or placebo for 12 weeks. The primary measure was BPI average pain. Secondary endpoints included Patient's Global Impressions of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), BPI-Severity (BPI-S), BPI-Interference (BPI-I), and response rates (either ≥30% or ≥50% BPI average pain reduction at endpoint). Health outcomes included Short Form-36, European Quality of Life–5 Dimensions, and the Work Productivity and Activity Impairment questionnaire. Safety and tolerability were assessed. Compared with placebo-treated patients, duloxetine-treated patients reported a significantly greater reduction in BPI average pain (P ≤ .001). Similarly, duloxetine-treated patients reported significantly greater improvements in PGI-I, BPI-S, BPI-I, 50% response rates, and some health outcomes. The RMDQ and 30% response rate showed numerical improvements with duloxetine treatment. Significantly more patients in the duloxetine group (15.2%) than patients in the placebo group (5.4%) discontinued because of adverse events (P = .002). Nausea and dry mouth were the most common treatment-emergent adverse events with rates significantly higher in duloxetine-treated patients.

Perspective
This study provides clinical evidence of the efficacy and safety of duloxetine at a fixed dose of 60 mg once daily in the treatment of chronic low back pain (CLBP). As of December 2009, duloxetine has not received regulatory approval for the treatment of CLBP.

[Tatonka_usn]

Interesting finding. I was put on 60mg of Duloxetine (Cymbalta eq.) for neuropathic pain associated with a herniation at L5/S1. Since my Micro-D in 2007, I've had varying levels of lower back and leg/foot pain, and it was thought that putting me on this med would help after I was unable to tolerate neurontin. Unfortunately, to date, I've seen very little improvement to either LBP or radicular symptoms (in fact, my pain has gotten worse). Just food for thought.....