title: A randomized, double-blind, placebo-controlled multicentre study to evaluate the efficacy and safety of diclofenac 4% spray gel in the treatment of acute uncomplicated ankle sprain.
abstract: OBJECTIVE
  A prospective, randomized, double-blind, placebo-controlled, parallel-group multicentre study to evaluate the efficacy and safety of diclofenac 4% spray gel for the treatment of acute, uncomplicated ankle sprain.
  
  
  METHODS
  Outpatients with acute, uncomplicated, one-sided ankle sprain were randomly assigned to receive diclofenac 4% spray gel or placebo (vehicle) three times daily for 14 ± 1 days. The main efficacy endpoint was the intra-individual response to treatment (≥ 50% decrease in swelling of the injured ankle after a treatment period of ≤ 10 days).
  
  
  RESULTS
  The response rate was significantly higher in the diclofenac group (n = 118) than the placebo group (n = 114) (91.5% vs. 82.5%). After 3-4 days' treatment, diclofenac spray significantly reduced swelling, spontaneous pain, pain on active movement and tenderness compared with placebo. Diclofenac spray was well tolerated, with a low overall rate of adverse events.
  
  
  CONCLUSIONS
  Diclofenac 4% spray gel rapidly relieves pain and improves mobility in patients with acute, uncomplicated ankle sprain and is well tolerated. It may be a useful treatment option for other acute soft tissue injuries.
authors.affiliation: DSHS Köln, Cologne, Germany.
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Predel
authors.forename: Bruno
authors.initials: B
authors.lastname: Giannetti
authors.forename: Bernd
authors.initials: B
authors.lastname: Seigfried
authors.forename: Roberto
authors.initials: R
authors.lastname: Novellini
authors.forename: Georg
authors.initials: G
authors.lastname: Menke
mesh_terms: D000208:Acute Disease; D000287:Administration, Topical; D000328:Adult; D016512:Ankle Injuries / Q000188:drug therapy* / Q000503:physiopathology; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D010045:Outpatients; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D010919:Placebos; D011446:Prospective Studies; D013180:Sprains and Strains / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D010919:Placebos; D004008:Diclofenac
keywords: Diclofenac sodium; ankle sprain; efficacy; randomized controlled trial; safety; spray formulation