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Abstract Introduction Fibromyalgia is a complex, generalized, and diffuse chronic musculoskeletal pain. Pharmacological approaches are widely used to relieve pain and increase quality of life. Low-Dose Naltrexone (LDN) was shown to increase the nociceptive threshold in patients with fibromyalgia. Transcranial Direct Current Stimulation (tDCS) is effective for pain management. Objective The purpose of this study was to evaluate the analgesic and neuromodulatory effects of a combination of LDN and tDCS in patients with fibromyalgia. Methods This was a randomized, double-blinded, parallel, placebo/sham-controlled trial (NCT04502251; RBR-7HK8N) in which 86 women with fibromyalgia were included, and written informed consent was obtained from them. The patients were allocated into four groups: LDN + tDCS (n = 21), LDN + tDCS Sham (n = 22), placebo + tDCS (n = 22), and placebo+tDCS Sham (n = 21). The LDN or placebo (p.o.) intervention lasted 26 days; in the last five sessions, tDCS was applied (sham or active, 20 min, 2 mA). The following categories were assessed: sociodemographic, Visual Analog Pain Scale (VAS), Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI-II), Profile of Chronic Pain Scale (PCP:S), Pain Pressure Threshold (PPT), and Conditioned Pain Modulation (CPM). Blood samples were collected to analyze BDNF serum levels. Results At baseline, no significant difference was found regarding all measurements. VAS pain was significantly reduced in the LDN + tDCS (p = 0.010), LDN + tDCS Sham (p= 0.001), and placebo+tDCS Sham (p= 0.009) groups. In the PCP:S, the LDN+tDCS group showed reduced pain frequency and intensity (p= 0.001), effect of pain on activities (p= 0.014) and emotions (p= 0.008). Depressive symptoms reduced after all active interventions (p > 0.001). Conclusion Combined LDN+tDCS has possible benefits in reducing pain frequency and intensity; however, a placebo effect was observed in pain using VAS, and further studies should be performed to analyze the possible association. complex generalized life LowDose Low Dose (LDN (tDCS management randomized doubleblinded, doubleblinded double blinded, blinded double-blinded parallel placebo/shamcontrolled placeboshamcontrolled placebo/sham controlled sham NCT04502251 NCT (NCT04502251 RBR7HK8N RBRHKN RBR 7HK8N HK N RBR-7HK8N 8 included them groups n 21, 21 , 21) 22, 22 22) placebotDCS 21. . p.o. po p o (p.o. days sessions min mA. mA mA) assessed sociodemographic (VAS) PCS, PCS (PCS) StateTrait State Trait STAI, STAI (STAI) FIQ, FIQ (FIQ) BDIII, BDIII BDI II (BDI-II) PCPS, PCPS PCP S (PCP:S) PPT, PPT (PPT) CPM. CPM (CPM) levels baseline measurements 0.010, 0010 0.010 0 010 0.010) p= 0.001, 0001 0.001 001 0.001) 0.009 0009 009 S, PCP:S LDNtDCS 0.014 0014 014 0.008. 0008 0.008 008 0.008) 0.001. however association shamcontrolled placebosham NCT0450225 (NCT0450225 HKN p.o (p.o (VAS (PCS (STAI (FIQ (BDI-II (PCP:S (PPT (CPM 0.01 01 000 0.00 00 NCT045022 (NCT045022 0.0 NCT04502 (NCT04502 0. NCT0450 (NCT0450 NCT045 (NCT045 NCT04 (NCT04 NCT0 (NCT0 (NCT