PainRelief.com: What should readers take away from your report?
Response: There are two main takeaways – one is that stimulation of the nerves of the ear may provide benefit for pain relief in patients with fibromyalgia, and the other is that this type of stimulation creates brain changes that could be suggestive of neural plasticity, resulting in long-term improvements in patient outcomes.
PainRelief.com: What recommendations do you have for future research as a result of this work?
Response: This study was not blinded, so participants knew if they were getting the device are not. Therefore, we cannot exclude a placebo effect. Also, it was a small study. Future studies should include a sham device to ensure adequate blinding. Also, a larger, randomized, double-blind, controlled study involving 50 or more participants is recommended to test the efficacy of the device. Because the device applies stimulation to the auricular branches of the cranial nerves, it would also be interesting to investigate which frequencies and which specific cranial nerve targets provide the most benefit. We suspect that it is vagal nerve input that is creating most of the positive effects that we observed. The device was a bit bulky and required weekly replacements, so a more user-friendly design with similar targets could also be explored.
Disclosures: I am a government employee, and this was a federally funded study with no industry sponsorship. I have nothing to disclose.
Anna Woodbury, MD, Venkatagiri Krishnamurthy, PhD, Melat Gebre, MD, Vitaly Napadow, PhD, Corinne Bicknese, MD, Mofei Liu, MSPH, Joshua Lukemire, MS, Jerry Kalangara, MD, Xiangqin Cui, PhD, Ying Guo, PhD, Roman Sniecinski, MD, MSCR, Bruce Crosson, PhD, Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial, Pain Medicine, , pnaa317, https://doi.org/10.1093/pm/pnaa317
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