Functionality of patients with fibromyalgia after the association of low-dose naltrexone (LDN) and transcranial direct current stimulation (tDCS).

Rodrigo Hernandes Paludo1, Mariane Schäffer Castro1, Tainá Ramires da Costa1, Fabrícia Fritz do Couto1, Felipe Fregni3, Liciane Fernandes Medeiros2,4, Andressa de Souza2,4

  1. Discente da Universidade La Salle, Canoas/RS;2. Programa de Pós-Graduação em Ciências Biológicas: Farmacologia e Terapêutica. Universidade Federal do Rio Grande do Sul, Porto Alegre/RS; 3. Neuromodulation Center and Center for Clinical Research Learning. Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Boston/MA;4. Programa de Pós-Graduação em Saúde e Desenvolvimento Humano da Universidade La Salle, Canoas/RS

OBJECTIVE: Evaluate the effect of the association of Low-Dose Naltrexone (LDN) and Transcranial Direct Current Stimulation (tDCS) on the functionality of patients with fibromyalgia (FM)

METHODS: A randomized, double-blind clinical trial was carried out, in which 86 women, aged between 18 and 65 years and diagnosed with FM, were included. Patients were randomized between LDN + tDCS (n = 21), LDN + Sham-tDCS (n = 22), Placebo + tDCS (n = 22) or Placebo + Sham-tDCS (n = 21), receiving 21 days of medication and 5 days of association. Patients underwent the following procedures: sociodemographic questionnaire and Profile of Chronic Pain Scale (B-PCP: S), subdivided into frequency and intensity of pain, effect of pain on activities and effect of pain on emotions. Data were analyzed using SPSS 20.0, using Friedman's test followed by Wilcoxon's Post-Hoc (significance when P <0.05).

RESULTS: There was no significant difference between groups in the baseline data (age, BMI, education; P>0.05), demonstrating to be a homogeneous sample. LDN + tDCS group showed a significant difference in the eighth assessment when compared to the first in frequency and intensity of pain (P<0.001) and effect of pain on activities (P=0.014), the domain effect of pain on emotions showed a significant difference when compared the fourth and eighth assessment with the first (P=0.008). In addition, the LDN + Sham-tDCS group showed a significant difference between the eighth-fourth assessment and eighth-first (P=0.008).

CONCLUSIONS: through this study it was possible to conclude that the association of LDN and ETCC is efficient in the functional improvement of patients with fibromyalgia.

KEYWORDS: fibromyalgia, low doses of naltrexone, transcranial direct current electrical stimulation