Home > Riviste > The Journal of Sports Medicine and Physical Fitness > Fascicoli precedenti > The Journal of Sports Medicine and Physical Fitness 2016 Gennaio-Febbraio;56(1-2) > The Journal of Sports Medicine and Physical Fitness 2016 Gennaio-Febbraio;56(1-2):92-9

ULTIMO FASCICOLO
 

ARTICLE TOOLS

Estratti

THE JOURNAL OF SPORTS MEDICINE AND PHYSICAL FITNESS

Rivista di Medicina, Traumatologia e Psicologia dello Sport


Indexed/Abstracted in: Chemical Abstracts, CINAHL, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,111


eTOC

 

ORIGINAL ARTICLES  SPORT INJURIES, REHABILITATION


The Journal of Sports Medicine and Physical Fitness 2016 Gennaio-Febbraio;56(1-2):92-9

lingua: Inglese

Diclofenac patch for the treatment of acute pain caused by soft tissue injuries of limbs: a randomized, placebo-controlled clinical trial

Hans Georg PREDEL 1, Helmut PABST 2, Axel SCHÄFER 2, Diedrich VOß 3, Nicola GIORDAN 4

1 German Sports University, Institute of Sports Medicine, Köln, Germany; 2 General practitioner, Internal and Sports Medicine Specialist, Essen, Germany; 3 Orthopedic Specialist, Waltrop, Germany; 4 Clinical Research Department, Fidia Farmaceutici, AbanoTerme, Italy


PDF  


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.

inizio pagina

Publication History

Per citare questo articolo

Corresponding author e-mail

ngiordan@fidiapharma.it