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Open Access Research article

Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study

Hans-Georg Predel1*, Bruno Giannetti2, Helmut Pabst3, Axel Schaefer4, Agnes M Hug5 and Ian Burnett6

Author Affiliations

1 Deutsche Sporthoschschule Köln, Köln, Germany

2 CRM clinical trials GmbH, Rheinbach, Germany

3 General Practitioner, Sports Medicine Specialist, Gilching, Germany

4 Practitioner for Internal Medicine and Sport, Essen, Germany

5 Novartis Consumer Health GmbH, Munich, Germany

6 Novartis Consumer Health SA, Nyon, Switzerland

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BMC Musculoskeletal Disorders 2013, 14:250  doi:10.1186/1471-2474-14-250

Published: 21 August 2013

Abstract

Background

Neck pain (NP) is a common musculoskeletal disorder in primary care that frequently causes discomfort. Non-steroidal anti-inflammatory drugs (NSAIDs) may be used to reduce neck pain and associated inflammation and facilitate earlier recovery. Topical diclofenac diethylamine (DDEA) 1.16% gel is clinically proven to be effective and well tolerated in acute and chronic musculoskeletal conditions, but until now no clinical data existed for its use in acute NP. The aim of this study was to assess the efficacy and safety of DDEA 1.16% gel compared with placebo gel in acute NP.

Methods

In a randomized, double-blind, placebo-controlled study, patients with acute NP (n = 72) were treated with DDEA 1.16% gel (2 g, 4x/day, for 5 days) or placebo. Efficacy assessments included pain-on-movement (POM), pain-at-rest (PAR), functional neck disability index (NDI) and response to treatment (decrease in POM by 50% after 48 h). Adverse events (AEs) were recorded throughout the study.

Results

The primary outcome, POM at 48 h, was statistically significantly lower with DDEA gel (19.5 mm) vs. placebo (56.9 mm) (p < 0.0001), representing a clinically relevant decrease from baseline (75% vs. 23%, respectively). All POM scores were significantly lower with DDEA gel vs. placebo from 1 h, as were PAR and NDI scores from first assessment (24 h) onwards (all p < 0.0001). Response to treatment was significantly higher with DDEA gel (94.4%) vs. placebo (8.3%) (p < 0.0001). There were no AEs with DDEA gel.

Conclusions

DDEA 1.16% gel, which is available over-the-counter, was effective and well tolerated in the treatment of acute neck pain. The tools used to assess efficacy suggest that it quickly reduced neck pain and improved neck function. However, questions remain regarding the comparability and validity of such tools. Further studies will help ascertain whether DDEA 1.16% gel offers an alternative treatment option in this common, often debilitating condition.

Trial registration

ClinicalTrials.gov identifier: NCT01335724

Keywords:
Acute neck pain; Diclofenac diethylamine gel; Neck function; Pain relief; Safety