{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:06:20Z","timestamp":1787018780710,"version":"build-2736575974"},"reference-count":36,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2013,7,31]],"date-time":"2013-07-31T00:00:00Z","timestamp":1375228800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Int Med Res"],"published-print":{"date-parts":[[2013,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u2009\u00b1\u20091 days. The main efficacy endpoint was the intra-individual response to treatment (\u226550% decrease in swelling of the injured ankle after a treatment period of \u226410 days).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The response rate was significantly higher in the diclofenac group ( n\u2009=\u2009118) than the placebo group ( n\u2009=\u2009114) (91.5% vs. 82.5%). After 3\u20134 days\u2019 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0300060513487639","type":"journal-article","created":{"date-parts":[[2013,8,1]],"date-time":"2013-08-01T04:16:34Z","timestamp":1375330594000},"page":"1187-1202","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":15,"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"],"prefix":"10.1177","volume":"41","author":[{"given":"Hans-Georg","family":"Predel","sequence":"first","affiliation":[{"name":"DSHS K\u00f6ln, Cologne, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Giannetti","sequence":"additional","affiliation":[{"name":"CRM Clinical Trials GmbH, Rheinbach, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Seigfried","sequence":"additional","affiliation":[{"name":"MIKA Pharma GmbH, Speyer, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Novellini","sequence":"additional","affiliation":[{"name":"MIKA Pharma GmbH, Speyer, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georg","family":"Menke","sequence":"additional","affiliation":[{"name":"GE-ME Design Analysis Clinical Trials, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2013,7,31]]},"reference":[{"key":"bibr1-0300060513487639","first-page":"1714","volume":"74","author":"Ivins D","year":"2006","journal-title":"Am Fam Physician"},{"key":"bibr2-0300060513487639","doi-asserted-by":"crossref","unstructured":"Kerkhoffs GM, Rowe BH, Assendelft WJ, et\u00a0al. 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