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document
Efficacy and safety of diclofenac diethylamine 1.16 % gel in acute neck pain : a randomized , double-blind , placebo-controlled study . 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 .
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Intervention_Pharmacological
diclofenac diethylamine
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Intervention_Pharmacological
Topical diclofenac diethylamine ( DDEA ) 1.16 % gel
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Intervention_Pharmacological
placebo gel
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Participant_Condition
acute neck pain
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Participant_Condition
acute NP
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Participant_Sample-size
72