Wristband, Coaching Program Improves QoL in Patients with Fibromyalgia

Caroline Maindet, MD

Credit: ResearchGate

A millimeter-wave emitting wristband (MMW) plus coaching program intervention improved quality of life in patients with fibromyalgia, according to data presented at the American College of Rheumatology’s 2023 Convergence in San Diego, California.¹ These results were superior to patients who received usual care and were maintained at month 6, when patients were instructed to use their wristband independently.

“Exposure of the peripheral nervous system to MMW has been shown to provide a neuromodulating effect, mediated by the release of various neurotransmitters, including endorphins,” stated lead investigator Caroline Maindet, MD, pain specialist at the University Hospital Grenoble Alpes, France, and colleagues. “Endorphins have pain relief and parasympathetic modulation properties that can alleviate the symptoms of fibromyalgia patients. Coaching aims to improve treatment adherence and efficacy.”

The symptoms of fibromyalgia vary in intensity and commonly include pain, cognitive impairment, fatigue, and sleep disturbance. Treatment options relying on the body’s endogenous opioid system may be a valuable non-pharmacological option for the management of this condition.

While the primary recommendation for this chronic condition is non-pharmacological treatments, such as physical therapy, patients with fibromyalgia may not be able to exercise due to their symptoms. Previous studies have demonstrated the benefits of increased activity for patients with fibromyalgia, including less pain and fatigue, as well as better sleep, mood, and quality of life.²

The multicenter, randomized controlled trial evaluated the efficacy of a combination of MMW and a coaching program intervention in 170 patients with a moderate or severe Fibromyalgia Impact Questionnaire (FIQ) score, defined as ≥39/100. Patients were placed in either the immediate intervention cohort (n = 84) or the delayed intervention cohort (n = 86). Those in the immediate group began treatment with the intervention directly after placement, plus usual care. Those in the delayed group began the intervention at month 3.

Both groups received treatment with the MMW wristband and coaching for 3 months, followed by wristband treatment alone for the next 3 months. Patients were required to use the wristband for 3 30-minute sessions a day and receive 4 coaching sessions, which included information about the intervention, device training, a usability assessment, and a benefit assessment. If during the benefit assessment, which occurred at months 1 and 2, investigators decided the patient had low benefits, the wristband’s stimulation mode (both power and duration) could be adjusted.

The efficacy of the intervention was determined by comparing the number of patients in the immediate and delayed cohorts who had a clinically significant improvement in the quality of life measurement on the FIQ between baseline and month 3, which was defined as a decrease in FIQ score of ≥14%. The FIQ scores of both groups were again measured at month 6.
At the 3-month mark, 55.1% of patients in the immediate group improved their quality of life >14%, compared with 35.9% in the delayed intervention group, which was deemed statistically significant (P = .021). Patients in the immediate cohort had FIQ score improvements of 21.7% compared with only 7.2% in the delayed group. Results were sustained to month 6, even though patients used their devices autonomously between month 3 and 6.

“This non-pharmaceutical therapy offers patients a therapy they can use independently and on an outpatient basis,” investigators concluded.

References

1. ^{MaindetC, DumolardA, VelosoM, Barmaki M, et al. Therapy Combining Millimeter Wave-based Neuromodulation with Coaching for the Improvement in Quality of Life of Patients with Fibromyalgia: A Prospective, Multicenter, Randomized, Controlled Trial. Presented at: American College of Rheumatology Convergence 2023. San Diego, CA. November 10-15, 2023.}
2. ^{Pine, L. (2023, June 18). Increasing activity, reducing stress led to symptom improvement in fibromyalgia. HCP Live. https://www.hcplive.com/view/increasing-activity-reducing-stress-led-to-symptom-improvement-in-fibromyalgia}