UČINAK INOVATIVNE KREME NA BOL, POKRETLJIVOST, FUNKCIONALNU SPOSOBNOST I KVALITETU ŽIVOTA U BOLESNIKA S NESPECIFIČNOM KRIŽOBOLJOM

Dinko Kolarić, Ana Kolarić, Ivan Sunara, Endi Radović, Zoran Vrbanac

Introduction. Non-specific low back pain is defined as pain between the rib cage and the lower fold of the buttocks, which cannot be associated with a specific pathology, but probably is of mechanical cause. The empirical use of a cream intended for the ease of mobility of the spine, called Beaute Vitale® (BV) which was used approximately 40 years ago in Southeastern Europe, showed a significant reduction in the symptoms of many diseases of the locomotor system, especially in non-specific low back pain. The main active ingredients of the cream are brown algae extract and turmeric. The aim of this study was to investigate the effect of the BV cream on pain intensity, mobility, functional capacity and quality of life in patients with non-specific low back pain. Patients and methods. The cream was applied to the skin of the lumbar and sacral region through 4 treatments during the course of one year, on the basis of 20 consecutive patients with acute and subacute non-specific low back pain. Each treatment lasted for 7 days. Before and after each treatment, including after the end of the entire treatment cycle, spinal mobility indices (Thomayer’s test), Schober’s test and lateral
flexion of the spine to the left and right were measured. In addition to that, the subjects filled out the validated Rolland- Morris Disability Questionnaire (RMDQ) as a standard measure of functional ability of patients with low back pain and the EQ-5D-5L as a validated measure of quality of life. To compare the results, depending on the data distribution, the T-test or the Wilcoxon test for dependent samples were used. Results. After one year (a total of 4 treatments), a significant difference was found in the clinical tests of lateral flexion (p<0.0001) and EQ-5D-5L, in the domains of pain (p<0.001) and mobility (p<0.01), as well as the VAS scale of overall health (p=0.05), and all of these changes revealed improved scores. No significant change was found in the measures of sagittal mobility (Thomayer’s test and Schober’s test), in the total value of the RMDQ, and in the EQ-5D-5L domains of activity, self-care and anxiety/depression. No significant skin changes or other side effects were observed when using the product. Conclusion. In our sample of subjects with acute and subacute non-specific low back pain, the BV cream showed positive effects on reducing the sense of pain, increasing spinal mobility and improving the general feeling of well-being. The BV cream can be recommended as supportive conservative therapy in these patients. Further research is needed in terms of additional assessment of the effect of this preparation.

Uvod. Nespecifična križobolja se definira kao bol između rebrenog luka i donje glutealne brazde, koja se ne može povezati sa specifičnom patologijom, a vjerojatno je mehaničkog uzroka. Empirijskim korištenjem kreme za olakšanu pokretljivost kralježnice, imenom Beaute Vitale® (BV), posljednjih četrdesetak godina u jugoistočnoj Europi pokazalo se značajno smanjenje simptoma sa strane mnogih bolesti lokomotornog sustava, osobito u nespecifičnoj križobolji. Osnovni aktivni sastojci kreme su ekstrakt smeđe alge i kurkuma. Cilj ove studije bio je istražiti učinak kreme BV na intenzitet boli, pokretljivost, funkcionalnu sposobnost i kvalitetu života u bolesnika s nespecifičnom križoboljom. Ispitanici i metode. Krema se nanosila na kožu lumbalne i sakralne regije kroz četiri tretmana tijekom jedne godine, na uzorku od 20 konsekutivnih bolesnika s akutnom i subakutnom nespecifičlnom križoboljom. Svaki tretman trajao je sedam dana. Prije i nakon svakog tretmana, uključivo i nakon završetka cjelokupnog ciklusa liječenja, mjereni su indeksi pokretljivosti kralježnice (Thomayerova mjera), Schoberov klinički test te laterofleksija kralježnice ulijevo i udesno. Također, ispitanici su ispunili validirane upitnike Rolland-Morris Disability (RMDQ) kao standardnu mjeru funkcionalne sposobnosti bolesnika s križoboljom i EQ-5D-5L kao validiranu mjeru kvalitete života. Za usporedbu rezultata, ovisno o distribuciji podataka, korišteni su T- test ili Wilcoxonov test za zavisne uzorke. Rezultati. Nakon jedne godine (ukupno četiri tretmana) nađena je značajna razlika u kliničkim testovima laterofleksije (p<0,0001) i EQ- 5D-5L i to u domenama za bol (p<0,001), mobilnost (p<0,01), kao i VAS skale ukupnog zdravlja (p=0,05), sve promjene u smislu poboljšanja rezultata. Nije nađena značajna promjena u mjerama sagitalne gibljivosti (Thomayerova i Schoberova mjera), u ukupnoj vrijednosti RMDQ, te EQ-5D-5L domeni aktivnosti, samozbrinjavanja i anksioznosti/ depresije. Nisu primijećene značajne kožne ili druge nuspojave pri primjeni preparata. Zaključak. U našem uzorku ispitanika s akutnom i subakutnom nespecifičnom križoboljom krema BV je pokazala pozitivne učinke smislu smanjenja boli, povećanja pokretljivosti kralježnice te poboljšanja općeg osjećaja zdravlja. Krema BV može se preporučiti kao suportivna konzervativna terapija u tih bolesnika. Potrebna su daljnja istraživanja u smislu dodatne ocjene učinka ovog preparata.