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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.
Acute pain begins
suddenly and is generally time limited and serves as an alert to the body after
injury. The visual analogue scale (VAS) score by injury location revealed some
significant improvements in the pain reduction as found in this research.
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.
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.
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.
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.
The Journal of sports medicine and physical fitness
http://www.minervamedica.it/en/journals/sports-med-physical-fitness/article.php?cod=R40Y2016N01A0092
Diclofenac patch for the treatment of acute pain caused by soft tissue injuries of limbs: a randomized, placebo-controlled clinical trial
Hans Georg PREDEL et al.
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