Br J Sports Med. Published Online First: 30 November 2006. doi:10.1136/bjsm.2006.030239
Paper |
Topical ketoprofen tds patch vs diclofenac gel: efficacy and tolerability in benign sport related soft-tissue injuries
1 Facultad de Ciencias de la Salud y del Deporte, Universidad Católica San Antonio de Murcia, Spain
2 Hospital Modelo, La Coruña, Spain
3 Centro de Medicina General y Deporte, Toledo, Spain
4 Hospital Miguel Domínguez, Pontevedra, Spain
5 Servicios Médicos de la Autoridad Portuaria de Valencia, Spain
6 Sanatorio Begoña, Gijón, Spain
* To whom correspondence should be addressed. E-mail: fesparza{at}pdi.ucam.edu.
Accepted 9 October 2006
Abstract
Objective: To compare ketoprofen tds patch with diclofenac gel in the treatment of traumatic acute pain in benign sport related soft-tissue injuries. Design: 7-14 treatment days, prospective, randomised, open study.
Patients: Outpatients aged 18-70 diagnosed of painful benign sport-related soft tissue injury (sprains, strains and contusions within the prior 48 hours) randomised to either Ketoprofen patch 100 mg once daily (n=114) or Diclofenac gel 2-4 gr thrice daily (n=109).
Intervention: 7-14 days topical NSAID treatment to assess the pain intensity changes (daily activities and spontaneous at rest) in a daily diary (100-mm Visual Analogue Scale [VAS]).
Main Outcome Measurement: Pain intensity (VAS).
Results: Ketoprofen patch was not inferior to diclofenac gel in reducing the baseline pain at daily activities (difference of -1.17 mm in favour of ketoprofen patch, 95%CI [-5.86; 3.52], reducing 79% the baseline VAS). Ketoprofen patch presented also a higher cured rate (64%) than diclofenac gel (46%) at day 7 (p=0.004). The patients’ opinion about the treatment comfort (pharmaceutical shape, application and dosage) was also statistically higher in Ketoprofen patch (over 80% of the patients rated as good or excellent the patch removal and skin adherence).
Conclusion: Ketoprofen patch is an effective and safe pain reliever for the treatment of sports injury pain with advantages compared to diclofenac gel.
Key Words: controlled clinical trial, non inferiority, pain, sports injury, topical drug
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