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: Hans-Georg Predel, Bruno Giannetti, Bernd Seigfried, Roberto Novellini, Georg Menke
• Journal: The Journal of international medical research (J Int Med Res) Vol. 41 Issue 4 Pg. 1187-202 (Aug 2013) ISSN: 1473-2300 [Electronic] England
• PMID: 23908551 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

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