Background: To evaluate the effectiveness of non-invasive neuro-adaptive electrostimulation (NAE) therapy for treating chronic pain and disability in patients with fibromyalgia. Method/design: A prospective, randomized, sham-controlled study was conducted in 37 women with fibromyalgia. Participants were randomly assigned to receive either active NAE (n = 20) or stimulation with a sham device (n = 17). Participants in the experimental arm received eight 30-minute sessions over 4 weeks (2 sessions per week). The sham group received eight 30-minute sessions of sham stimulation. Therapeutic effects on pain relief, disability, and quality of life were evaluated using outcome measures at baseline, at 4 weeks, and after 3 months’ follow-up. Results: The findings indicated a significant reduction of pain in the active NAE group compared with the sham group immediately post-intervention, with a difference on the Visual Analog Scale (VAS) of 3 points ( P = .001), and at 3 months’ follow-up ( P = .02). There were significant intragroup differences between the groups ( P < .05) at post-intervention. After the intervention, both groups presented significant reductions on the Fibromyalgia Impact Questionnaire (FIQ) with respect to baseline ( P = .004), but not at the 3-month follow-up. In the conditioned pain modulation (CPM) in thumb variable we found significant differences between the groups at the 3-month follow-up ( P = .02). No additional benefits for conditioned pain modulation and disability were observed between groups at the 3-month follow-up. Furthermore, anxiety/depression and catastrophizing improved in both groups, but no differences between groups were found. Conclusions: In this fibromyalgia cohort, NAE therapy significantly improved pain and quality of life at 4 weeks, but not at 3-month follow-up, compared with the sham stimulation group. Future investigations are needed in larger populations to confirm these findings.

This randomized clinical trial evaluates the success rate of neuro-adaptive therapy (NAT), applied with a specific neuro-adaptive regulator device, the Self-Controlled Electro Neuro-Adaptive Regulation (SCENAR), versus a sham for urge incontinence due to an overactive bladder (OAB). From February 2019 to May 2021, 66 patients were recruited. All subjects were randomized 1:1 at the first intervention visit to the NAT or sham procedure. Inclusion criteria were females between 18 and 80 years old with leakages due to an overactive bladder with unresponsiveness to medical therapy. Subjects were scheduled to receive up to eight weekly 20 min intervention sessions to obtain a complete (CR) or partial response (PR). Patients with no response after three sessions were considered as a failure. The primary end point of this trial was to assess the efficacy of NAT compared to an inactive sham intervention, evaluated 1 month after the last session. Analysis showed 23 (70%) patients responded (20 complete and 3 partial response) in the NAT group compared to 16 (48%) patients (all complete response) in the placebo arm (p = 0.014). Significant differences were maintained after the intervention, with persistent response at 3 months in 19 (58%) patients after active treatment and 14 (42%) after the placebo (p < 0.001), and at 6 months in 18 (55%) vs. 11 (33%) (p = 0.022), respectively. The number of sessions to achieve CR was similar in both arms, with 4.3 ± 1.9 in NAT and 3.9 ± 1.8 in the sham group (NS). Significant differences were observed between both groups for patients’ satisfaction (p = 0.01). The binary model selected age as a predictor of response at the last follow-up. The odds ratio indicates that each year of increase in age, the probability of a positive response to treatment at 6 months decreases 0.95 (95% CI 0.9–0.99) times (p = 0.03). In conclusion, this pilot randomized trial gives evidence that neuro-adaptive electrostimulation is effective to treat refractory urge urinary incontinence due to OAB. The security and long-term efficacy of this treatment merits further evaluation. Moreover, its favorable profile and the economic advantages of the device make the evaluation of this promising technique mandatory in a primary therapeutic scenario.