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

Hans-Georg Predel, Bruno Giannetti, Helmut Pabst, Axel Schaefer, Agnes M Hug, Ian Burnett, Hans-Georg Predel, Bruno Giannetti, Helmut Pabst, Axel Schaefer, Agnes M Hug, Ian Burnett

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.

Figures

Figure 1
Figure 1
Progress of patients throughout the trial.
Figure 2
Figure 2
Pain-on-movement (POM) over time (5 days of treatment). There was a significantly greater reduction in POM with DDEA 1.16% gel compared with placebo from the first assessment at 1 h to the final visit at 96 h (p < 0.0001).
Figure 3
Figure 3
Pain-at-rest (PAR) over time (5 days of treatment). PAR was significantly lower with DDEA 1.16% gel vs. placebo at all post-baseline visits (p < 0.0001).
Figure 4
Figure 4
Functional impairment (Neck Disability Index, NDI) over time (5 days of treatment). The NDI score demonstrated that patients’ function improved significantly with DDEA 1.16% gel vs. placebo from the first to the last assessment (p < 0.0001).

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