Wearable Device Provides Long-Term Relief for Fibromyalgia

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A wearable neuromodulation device using millimeter waves (MMW) may help people with fibromyalgia experience lasting relief.

“Fibromyalgia is a widespread pain condition, associated with other symptoms such as fatigue, sleep disorders, stiffness and mood disturbances,” wrote a group of French investigators. “It significantly impacts patients’ quality of life and poses a substantial challenge due to the lack of a definitive cure.”

Nonpharmacological interventions, including yoga, cognitive behavioral therapy, acupuncture, exercise and MMW, are recommended as first-line treatments for the condition. MMW are electromagnetic radiation with frequencies ranging from 30 to 300 GHz (extremely high frequency). This exposure can lead to endorphin release, modulation of the parasympathetic activities and hypoalgesic effects. It can reduce pain after surgery, joint pain and neuropathic pain as well as improve stress regulation and sleep.

Based on these benefits, a monthly subscription package consisting of an MMW-emitting device and a smartphone app was offered to the public to improve quality of life of people experiencing pain, stiffness, fatigue and sleep issues. Participants could track their symptoms and wristband use.

Many participants with fibromyalgia continued to use the subscription service for more than 18 months. Investigators were interested in understanding improvements in quality of life and fibromyalgia symptoms among MMW-base neuromodulation users and determine their long-term evolution using data from the program.

A total of 185 users were included in the retrospective study. Most participants were women (94.6%) and had fibromyalgia, and the mean age was 52.1 years. The median duration of pathology was 14 years. Apart from fibromyalgia, other common comorbidities were migraine and osteoarthritis.

Over 18 months, participants using the device reported improvements in quality of life, pain levels, sleep, stiffness and fatigue. After the first three months, investigators saw an average 27% reduction in the Fibromyalgia Impact Questionnaire (FIQ) scores — indicating sustained improvements.

At baseline, 62.5% of users were considered to have severe fibromyalgia, compared with only 5.7% in the mild category. After month three, only 22.1% of users had severe fibromyalgia. The quality of sleep improved by 21% at three months, which remained stable throughout the follow-up period.

Notably, pain levels — measured using a Visual Analogical Scale (VAS) in which 0 meant no pain and 100 meant maximal pain — continued to decline over time. The mean pain intensity reduced from 56.7 at baseline to 35.4 at week 72.

These findings highlight the potential of nondrug therapies like MMW technology to offer meaningful, long-term benefits for those living with fibromyalgia.

Investigators noted some important limitations. Since it was an open-label, single-group study, participants chose to use the device rather than being randomly assigned, which could introduce bias. The fibromyalgia diagnoses were self-reported instead of being confirmed by doctors, and the study only included people who continued using the device for 18 months, leaving out those who stopped earlier. Sleep quality and pain levels were measured using custom surveys, making comparisons with other studies difficult. Additionally, the analysis did not track medication use or other treatments that might have influenced results.

However, real-world data like these provide valuable insights into how treatments work in everyday life and over the long term, complementing more controlled clinical trials.

“As digital health technologies continue to evolve, the integration of such innovative solutions into chronic pain management protocols presents a valuable opportunity for improving patient care,” investigators concluded. “Future studies should aim to further validate these findings in larger and more diverse populations.”