Efficacy and safety of Ketoprofen Gel treatment in patients with low back pain

Abstract

Background. The purpose was to study the effectiveness and safety of Ketoprofen gel (Fastum gel) therapy in patients with low back pain (LBP) caused by degenerative-dystrophic changes of the spine. Materials and methods. 24 males and females aged 50-69 years with LBP lasting over 14 days were examined, with a further division into two groups. Group I – 12 patients received thin ketoprofen applications on the lumbar region 2 times a day for 10 days. Group II – 12 patients who received thin applications of Vaseline on the same area 2 times a day for 10 days. Patients used the study drugs as a monotherapy. Examination was performed before the treatment initiation, after 10 and 20 days of treatment. Results. Patients receiving ketoprofen applications had a significantly reduced pain intensity registered by all four components of VAS and the Roland-Morris questionnaire. At the same time, the functional capacity by Schober (t = 3.54, p = 0.005) and Tomayer (t = 3.08, p = 0.01) tests was significantly improved. The quality of life according to the EuroQul-5D scale in patients who used the topical ketoprofen significantly increased by 45 % (t = 4.19, p = 0.002), and life expectancy according to the Oswestry questionnaire by 39.3 % after 10 days of treatment (t = 3.9, p = 0.002). 75 % of patients from the main group and 33.3 % from the compa­rison group assessed the effectiveness of treatment as high according to the Likert index. Neither group reported localized nor systemic side effects. Conclusions. Monotherapy of ketoprofen gel significantly reduced the intensity of pain and improved the functional capacity of patients with LBP. The absence of side effects during treatment indicates its high safety profile for patients.

Keywords

• low back pain, topical form, ketoprofen gel