A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial.

BACKGROUND: Fibromyalgia is a form of chronic widespread pain that is defined as a syndrome of chronic symptoms of moderate to severe intensity, including diffuse pain, fatigue, sleep disturbance, cognitive impairment, and numerous somatic complaints. To date, there is no specific drug treatment for fibromyalgia but only symptomatic treatments. A drug free solution based on a wristband that emits millimeter waves associated with a therapeutic coaching program was developed. The application of millimeter waves on an innervated area has been described to have a neuromodulating effect, due to endorphin release stimulation and parasympathetic activation. Coaching is carried out to improve the patient's adherence and to increase compliance and effectiveness of the treatment. Regular use of this solution by fibromyalgia patients is expected to improve sleep quality, reduce anxiety and pain levels, and, at the end, increase the quality of life. METHODS: This trial is performed over 8 French inclusion centers for a total of 170 patients. The effectiveness of the solution is evaluated according to the primary objective, the improvement of the quality of life measured through the dedicated Fibromyalgia Impact Questionnaire after 3 months. Patients are randomized in two groups, Immediate or Delayed. The Immediate group has access to the solution just after randomization in addition to standard care, while Delayed has access to the standard of care and waits for 3 months to have the solution. The purpose of this methodology is to limit deception bias and facilitate inclusion. The solution consists in using the device for three sessions of 30 min per day and four coaching sessions spread over the first 2 months of wristband usage. DISCUSSION: The objective is to confirm the effect of the integrative approach based on endorphin stimulation and a therapeutic coaching program in nociplastic pain and specifically for the patient suffering from fibromyalgia. If the effectiveness of the solution is demonstrated, we will be able to respond to the demand of fibromyalgia patients for access to an effective non-medicinal treatment to improve their quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05058092.

Alumina nanoparticles size and crystalline phase impact on cytotoxic effect on alveolar epithelial cells after simple or HCl combined exposures.

Applications using alumina nanoparticles (Al2O3 NPs) have incredibly increased in different fields of activity. In defense and aerospace fields, solid composite propellants use leads to complex combustion aerosols emissions containing high concentrations of Al2O3 NPs and hydrogen chloride gas (HCl). To better characterize potential hazard resulting from exposure to these aerosols, this study assesses cytotoxic effects of mixtures containing both compounds on human pulmonary alveolar epithelial cells (A549 cell line) after 24 h exposures. After all co-exposures cell viability was >80%. However co-exposures decrease normalized real-time cell index. Significant decreases of intracellular reduced glutathione pool were also observed after co-exposures to γ-10 nm or γ/δ-13 nm Al2O3 NPs and HCl. Co-incubations with γ/δ-13 nm or γ-500 nm Al2O3 particles and HCl induced significant DNA double-strand breaks increases. Moreover all co-exposures and HCl alone disrupted cell cycle (increased G1 phase cells). Transmission Electron Microscopy (TEM) observations revealed γ/δ-13 nm Al2O3NPs adsorption and internalization in cell cytoplasm only, suggesting indirect genotoxic effects. According to our results Al2O3 particles/HCl mixtures can induce cytotoxic effects and Al2O3 size and crystallinity are two main parameters influencing cytotoxic mechanisms.