Effect of Systemic and Auricular Acupuncture with a 2/100 Hz Frequency and Nogier Frequency in Fibromyalgia: a Randomized Clinical Trial, Pilot Study

Fibromyalgia is a chronic and generalized muscle pain syndrome that significantly affects quality of life, accompanied by sleep disturbances, fatigue, and cardiac autonomic dysfunction. With a worldwide prevalence of 2% and the absence of a gold-standard treatment, non-pharmacological therapies such as acupuncture have gained prominence as effective alternatives. This randomized controlled pilot study investigated an innovative approach that combines systemic electroacupuncture with auriculotherapy using specific Nogier frequencies for the treatment of fibromyalgia. The study was conducted at the Federal University of Alfenas between 2019 and 2020, rigorously following the CONSORT and STRICTA guidelines for acupuncture clinical trials.

Eighteen women aged between 40 and 78 years, diagnosed with fibromyalgia according to the 2010 American College of Rheumatology criteria, were randomized into two equal groups. The experimental group received a treatment protocol that included bilateral electroacupuncture at the systemic points ST-36 (Zusanli) and BL-60 (Kunlun) with mixed frequencies of 2/100 Hz, combined with unilateral auriculotherapy at seven points (Shenmen, kidney, sympathetic, liver, lung, spleen-pancreas, and ACTH) using Nogier frequencies A (2.28 Hz), B (4.56 Hz), and C (9.12 Hz). The treatment consisted of 12 sessions over 6 weeks, lasting 20 minutes each. The control group received only an educational lecture on fibromyalgia.

Primary and secondary outcomes were assessed using the Numerical Pain Rating Scale (NPRS), the 2010 Fibromyalgia Diagnostic Criteria (FDC), the Fibromyalgia Impact Questionnaire (FIQ), and heart rate variability (HRV) analysis. The results revealed promising findings on specific aspects of quality of life. Although there was no statistically significant difference in pain intensity measured by the NPRS, the study demonstrated clinically relevant improvements in important FIQ domains. The total FIQ score showed a significant difference (p = 0.008) favoring the experimental group, with a high effect size (1.39) and adequate statistical power (0.86).

Specifically, there was a significant reduction in pain assessed by the corresponding FIQ domain (p = 0.02) and a notable improvement in anxiety levels (p = 0.006), both with considerable effect sizes. No significant changes were observed in the FDC 2010 diagnostic criteria or in the heart rate variability parameters. From a mechanistic standpoint, low-frequency electroacupuncture (2 Hz) is associated with the release of enkephalins and activation of μ-opioid receptors, while high frequency (100 Hz) promotes the release of dynorphin and activation of κ receptors. The Nogier frequencies used in auriculotherapy have specific functions: frequency A (2.28 Hz) stimulates cellular mechanisms and is indicated for inflammatory pathologies; frequency B (4.56 Hz) stimulates multicellular functions related to nutrition and immunity; and frequency C (9.12 Hz) acts on muscle contraction and spasms.

This innovative combination represents a unique approach not previously described in the literature. The clinical implications of this study are important for professionals who care for patients with fibromyalgia. The significant improvement in quality of life, particularly in pain and anxiety reduction, suggests that this combined approach may be a valuable tool in the multidisciplinary management of fibromyalgia. The fact that no adverse events were reported reinforces the safety profile of the treatment.

However, it is important to recognize the limitations of the study, including the small sample size, absence of blinding of researchers and participants, lack of a placebo group, and long-term follow-up. These limitations may influence the generalizability of the results and require caution in the interpretation of the findings. Future studies with larger samples and more robust methodology are needed to confirm these promising results and establish standardized protocols for this innovative therapeutic approach.