Background/Purpose: Fibromyalgia is a chronic syndrome with symptoms of moderate to severe intensity, including diffuse pain, fatigue, sleep disturbance, and cognitive impairment. While first-line recommendation for this pathology is non-drug therapies (Macfarlane et al., 2017), namely physical therapy, symptoms often prevent patients from exercising. Therapies that rely on the body’s endogenous opioid system thus present an interesting non-pharmacological method of helping patients. The objective of this trial was to assess the efficacy of an intervention combining a millimeter-wave emitting wristband (MMW) and a coaching program. 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. Endorphins have pain relief and parasympathetic modulation properties that can alleviate the symptoms of fibromyalgia patients. Coaching aims to improve treatment adherence and efficacy.

Methods: In a multicenter, randomized, controlled trial (ClinicalTrials.gov NCT05058092), 170 fibromyalgia patients (ACR 2016 criteria, Wolfe et al., 2016) ) with moderate or severe Fibromyalgia Impact Questionnaire score (FIQ, Bennett et al., 2009, score ≥ 39/100) were divided into 2 groups of immediate (IG) or delayed (DG) intervention. The IG (N=84) received the intervention immediately after groups were assigned, in addition to their usual care (UC). The DG (N=86) received the intervention with a delay of 3 months, intervention starting after assessment of the primary endpoint (M3). In both groups, patients first received MMW wristband treatment and coaching for 3 months, then wristband treatment alone for 3 months. The intervention consisted of using the wristband for three 30-minute sessions a day and receiving 4 coaching sessions including educational content on the intervention and training in the use of the device (D0), a usability assessment (D7) and a benefit assessment (M1 and M2). In the event of low benefit at M1 or M2, the wristband’s stimulation mode (power & duration) could be adapted. Efficacy of intervention was assessed by comparing the number of patients in both groups whose quality of life measurement on the FIQ significantly improved between inclusion and M3. A decrease in FIQ score of ≥14% is considered clinically significant (Bennett et al., 2009). FIQ scores of the 2 groups were also measured at 6 months (M6).

Results: At M3, 55.1% patients of IG improved their quality of life beyond 14%, compared with 35.9% in the DG, and this difference between the groups was statistically significant (p=0.021). On average, patients in the IG improved their FIQ score by 21.7%, versus 7.2% in the DG. Benefits observed in the IG were preserved at M6, patients in this group having used their device autonomously between M3 & M6.

Conclusion: The combination of MMW and coaching led to improvements in the quality of life of fibromyalgia patients superior to those obtained with UC after M3. This improvement was maintained at M6, while patients were using their wristband autonomously. This non-pharmaceutical therapy offers patients a therapy they can use independently and on an outpatient basis.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/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/