Effects of a transcutaneous auricular vagus nerve stimulation protocol in individuals with fibromyalgia: study protocol

This study describes a protocol for evaluating the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on pain, the impact of fibromyalgia (FM), and quality of life in women with FM. Forty women 18 to 70 years of age with FM will be randomly allocated to one of two groups: active taVNS and sham taVNS. Pain, the impact of FM, and quality of life will be investigated using validated questionnaires. Assessments will be performed prior to the first intervention session and after the last session. The results of this study may provide a novel non-invasive therapeutic approach for the management of FM-related symptoms. The Brazilian Clinical Trials Registry identifier is RBR-2b4t4y2. What is this article about?Fibromyalgia is a long-term condition that can cause widespread pain, tiredness, and difficulties in daily life. This study will examine whether a gentle electrical stimulation applied to the outer ear can help women with fibromyalgia. This type of treatment is called transcutaneous auricular vagus nerve stimulation (taVNS). The study will include 40 women aged 18 to 70 years who have fibromyalgia. They will be randomly assigned to receive either active taVNS or a sham treatment. Pain, the impact of fibromyalgia on daily life, and quality of life will be assessed before and after the treatment. What do the results of the study mean?This study will help us understand whether stimulation of the ear can reduce pain and improve quality of life in women with fibromyalgia. Because this is a study protocol, the results are not yet known. If the treatment is found to be helpful, it may provide another non-drug option for managing symptoms of fibromyalgia. The study may also improve our understanding of how this type of treatment could be used to support people living with fibromyalgia.