Efeito de uma dispersão micelar nanoestruturada contendo óleo de Piqui Caryocar Coriaceum Wittm na dor e funcionalidade em mulheres com osteoartrite de joelho: ensaio clínico randomizado duplo cego

Abstract

Knee osteoarthritis (KO) is a clinical condition that involves the progressive degeneration of anatomical structures, especially affecting the cartilage and menisci. This condition is one of the main causes of pain and mobility limitations worldwide, also affecting individuals' quality of life. Given this context, the search for new therapeutic approaches is ongoing, especially those involving natural products. The Caryocar coriaceum specie, also known as “piqui”, natively exploited plant, typical of the Chapada do Araripe region in Ceará (Brazil), has anti-inflammatory and antioxidant properties due to the presence of bioactive compounds, such as unsaturated fatty acids and tocopherol. These compounds can reduce the production of pro-inflammatory mediators, such as cytokines and prostaglandins, reduces oxidative stress, in addition to analgesic activity, which helps to relieve pain associated with arthritis. In this sense, the objective of this study was to evaluate the effects of applying a nanoemulsion formulation in spray form containing piqui oil on pain and functional capacity in women with knee osteoarthritis. To this end, we carried out a study with women aged 40 to 65 years, who had received a clinical diagnosis of KO and who were patients at a rheumatology outpatient clinic at a University Hospital of Sergipe. All project protocols were duly approved by the Human Research Ethics Committee of the Federal University of Sergipe (UFS) (opinion no. 6494407). Participants were allocated into four groups: Physiotherapy Group, Combined Therapy Group, Formulation Group and Placebo Group. Different tests were carried out before and after treatment (8 weeks), including: collection of biochemical indicators, application of the quality of life questionnaire (WOMAC), TAMPA Scale of kinesiophobia, Pain Catastrophizing Scale, Lysholm Questionnaire for symptoms of knee, Numerical Verbal Scale for pain, dynamometry to assess muscle strength, algometry for pain perception, fleximetry for range of motion, six-minute walk test and Time Up And Go (TUG) for cognitive motor assessment. The data obtained were analyzed using two-way ANOVA for repeated measures. It was observed that the formulation containing piqui provided improvements in several parameters when compared to the placebo group, including pain symptoms (F1, 13=38.322; p=0.000); muscle strength for flexion (F3, 98=0.216; p=0.884), extension (F3, 99=0.008; p=0.999); conditioned pain modulation and pressure pain threshold (Algometry) (F1, 13=13.827; p=0.000); and range of movement (F1, 14=7.712; p=0.002). In relation to range of motion, only the formulation was able to promote significant improvements in the patients' condition. Furthermore, treatments with physiotherapy or combined therapy also demonstrated beneficial results compared to the placebo group, improving pain and knee symptoms (p<0.05) and walking quality (p<0.05). Regarding biochemical parameters, IL-6 and TNF-alpha, no differences were observed between the groups. Based on the results obtained, the nanostructured pharmaceutical formulation containing piqui oil showed promising results in the treatment of osteoarthritis, either as an isolated treatment or as an adjuvant to conventional physiotherapy and can be considered a therapeutic alternative of interest for further studies. Furthermore, the study corroborates the popular use of piqui in the management of joint pain.