title: Diclofenac patch for the treatment of acute pain caused by soft tissue injuries of limbs: a randomized, placebo-controlled clinical trial.
abstract: BACKGROUND
  This study aimed to assess the efficacy and the safety of a newly-developed patch containing diclofenac sodium 140 mg in patients affected by acute soft tissue sport injuries, such as contusion, strain and sprain with a randomised, double-blind, placebo-controlled trial.
  
  
  METHODS
  One hundred and sixty-four subjects were recruited within 3 hours of a soft-tissue sport injury and were equally assigned to receive diclofenac or placebo patch applied twice a day for 7 days. The primary study endpoint was reduction in severity of pain on movement from baseline to 48 hours measured by Visual Analogue Scale. Secondary outcomes were reduction of pain on movement and at rest, reduction of pain on pressure, time to efficacy onset, global efficacy assessment and use of rescue analgesics.
  
  
  RESULTS
  The reduction of pain on movement from baseline to day 2 was markedly greater in the diclofenac group compared with placebo (treatment effect: -24.25 mm, P<0.001 between groups). Statistically significant improvements were also observed in the diclofenac group compared to placebo for the secondary variables of pain on movement and at rest, pain on pressure, time to efficacy onset and global patient and investigator efficacy assessment. Local adverse reactions at the application site were reported in comparable rates in the two groups.
  
  
  CONCLUSIONS
  The diclofenac patch could be a safe and effective alternative to the oral administration of non-steroidal anti-inflammatory drugs in the treatment of minor sport injuries.
authors.affiliation: German Sports University, Institute of Sports Medicine, Köln, Germany - ngiordan@fidiapharma.it.
authors.forename: Hans Georg
authors.initials: HG
authors.lastname: Predel
authors.forename: Helmut
authors.initials: H
authors.lastname: Pabst
authors.forename: Axel
authors.initials: A
authors.lastname: Schäfer
authors.forename: Diedrich
authors.initials: D
authors.lastname: Voss
authors.forename: Nicola
authors.initials: N
authors.lastname: Giordan
mesh_terms: D059787:Acute Pain / Q000188:drug therapy* / Q000209:etiology; D000279:Administration, Cutaneous; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001265:Athletic Injuries / Q000150:complications; D003288:Contusions / Q000150:complications*; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005121:Extremities; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009068:Movement; D059352:Musculoskeletal Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D011312:Pressure; D012146:Rest; D013180:Sprains and Strains / Q000150:complications*; D057968:Transdermal Patch; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac