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

J Int Med Res. 2013 Aug;41(4):1187-202. doi: 10.1177/0300060513487639.


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.

Keywords: Diclofenac sodium; ankle sprain; efficacy; randomized controlled trial; safety; spray formulation.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Administration, Topical
  • Adult
  • Ankle Injuries / drug therapy*
  • Ankle Injuries / physiopathology
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Diclofenac / therapeutic use*
  • Double-Blind Method
  • Female
  • Gels
  • Humans
  • Male
  • Outpatients
  • Pain / drug therapy*
  • Pain / physiopathology
  • Pain Measurement
  • Placebos
  • Prospective Studies
  • Sprains and Strains / drug therapy*
  • Sprains and Strains / physiopathology
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Gels
  • Placebos
  • Diclofenac