НОВЫЕ ВОЗМОЖНОСТИ ЛОКАЛЬНОЙ ТЕРАПИИ БОЛЕВОГО СИНДРОМА В СПИНЕ

Abstract

Purpose of study – to examine effectiveness and tolerability of therapy рatch NANOPLAST forte in comparison with “placebo” patch in patients with back pain syndrome in conditions of prospective comparative randomized study, approved by the local ethics committee. Materials and methods. The study included 60 patients with acute/ recrudescence of chronic primary back pain syndrome, there were 30 patients in each group, which were comparable in main clinical parameters. A primary effectiveness criterion was reduction of back pain syndrome intensity at rest and during movements by no less than 50% from initial level according to visual analogue scale (mm). Overall effectiveness of NANOPLAST forte patch was evaluated separately by doctor and patient on the 10th day according to the following grading: significant improvement; improvement; absence of effect. A need for administration of non-steroidal anti-inflammatory drugs (NSAID) was assessed during the study. A patch was applied once a day for 12 h (from 9 to 21 h). Tolerability of NANOPLAST forte patch and “Placebo” patch was evaluated according to frequency and severity of local and/or systemic adverse events, and to tolerability grading: very good effect, good effect, satisfactory effect, absence of effect. Frequency of achievement of not less than 50% of back pain reduction at rest was significantly higher in NANOPLAST forte group than in “placebo” group (96,6% versus 23.3% respectively; р=0.001, Pearson’s chi-squared test), as well as during movements (93,3% versus 40% respectively; р=0.001, Pearson’s chi-squared test). Evaluation of treatment effectiveness was higher in NANOPLAST forte group in comparison with “Placebo” group in the opinion of both patient and doctor. Pain intensity during walking and at rest statistically significantly decreased according to visual analogue scale (p<0.05, Wilcoxon test) by the 10th day  in NANOPLAST forte group. A need for additional administration of non-steroidal anti-inflammatory drugs was statistically significantly lower in NANOPLAST forte group in comparison with “Placebo” group (р<0.05, Pearson’s chi-squared test). All patients completed the study. Adverse events related to use of NANOPLAST forte patch were not detected. Conclusion. NANOPLAST forte can be recommended as an effective and safe method of local therapy in case of back pains.