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BackgroundFibromyalgia pain and related symptoms are poorly managed by approved pharmacological and alternative interventions. This trial aimed to evaluate the effects of the EXOPULSE Mollii Suit—a multisite transcutaneous electrical nerve stimulation device—on fibromyalgia pain, fatigue, affective symptoms, disease impact, and quality of life.MethodsAdult patients with fibromyalgia were enrolled. Phase 1 implied a randomized, sham‐controlled, cross‐over, double‐blind trial, applying daily 1 h sessions of active or sham intervention, over 2 weeks (2‐week washout). In the open‐label phase 2, all patients received daily active intervention for 4 weeks. Comparisons on pain, fatigue, disease impact, affective symptoms, quality of life, clinical impression, and comfort ratings were performed using Friedman, Wilcoxon signed rank, and Chi2 tests.ResultsThirty‐three patients completed the study (93.9% female, mean age: 51.3 years). Pain (primary endpoint assessed via a visual analog scale) was significantly reduced after the active (pre‐active: 6.9 ± 1.4, post‐active: 5.9 ± 1.8, pre‐sham: 6.8 ± 1.4, post‐sham: 6.6 ± 1.5) versus the sham intervention (X2 = 10.60, p = 0.014). This was also the case of other secondary endpoints (i.e., fatigue, anxiety, and disease impact), except depression and quality of life. The Clinical Global Impression of Change (CGI‐C) was significantly different between the active and sham intervention periods (X2 p = 0.035), and the different proportions of categories were as follows: ‘worsening’ (sham: 18.2% vs. active: 0.0%), ‘improvement’ (sham: 48.5% vs. active 63.6%) or ‘no change (sham: 33.3% vs. active 36.4%) respectively. After phase 2, significant positive effects were observed for most of the outcomes, and 78.8% of patients reported improvement according to CGI‐C.ConclusionsThis study suggests the clinical benefits of the EXOPULSE Mollii Suit in alleviating pain and fibromyalgia‐related fatigue, emotional symptoms, and disease impact. It is worth noting that the study has several limitations related to the low number of participants, the short‐term analysis of effects in the first blinded and controlled phase, and the open‐label nature of phase 2. Future studies with a larger cohort and longer protocol treatment are needed, to further confirm the current results, and evaluate the long‐term effects of this technique.SignificancePatients with fibromyalgia suffer from pain as well as fatigue, sleep impairment, emotional disturbances, and altered quality of life. Transcutaneous electrical nerve stimulation might help manage those symptoms, but the available systems are limited by the fact that they could be applied at best over two sites. This randomized controlled study is the first to apply a multi‐site transcutaneous electrical nerve stimulation device, the EXOPULSE Mollii Suit, with significant effects on fibromyalgia pain and related symptoms.
BackgroundFibromyalgia pain and related symptoms are poorly managed by approved pharmacological and alternative interventions. This trial aimed to evaluate the effects of the EXOPULSE Mollii Suit—a multisite transcutaneous electrical nerve stimulation device—on fibromyalgia pain, fatigue, affective symptoms, disease impact, and quality of life.MethodsAdult patients with fibromyalgia were enrolled. Phase 1 implied a randomized, sham‐controlled, cross‐over, double‐blind trial, applying daily 1 h sessions of active or sham intervention, over 2 weeks (2‐week washout). In the open‐label phase 2, all patients received daily active intervention for 4 weeks. Comparisons on pain, fatigue, disease impact, affective symptoms, quality of life, clinical impression, and comfort ratings were performed using Friedman, Wilcoxon signed rank, and Chi2 tests.ResultsThirty‐three patients completed the study (93.9% female, mean age: 51.3 years). Pain (primary endpoint assessed via a visual analog scale) was significantly reduced after the active (pre‐active: 6.9 ± 1.4, post‐active: 5.9 ± 1.8, pre‐sham: 6.8 ± 1.4, post‐sham: 6.6 ± 1.5) versus the sham intervention (X2 = 10.60, p = 0.014). This was also the case of other secondary endpoints (i.e., fatigue, anxiety, and disease impact), except depression and quality of life. The Clinical Global Impression of Change (CGI‐C) was significantly different between the active and sham intervention periods (X2 p = 0.035), and the different proportions of categories were as follows: ‘worsening’ (sham: 18.2% vs. active: 0.0%), ‘improvement’ (sham: 48.5% vs. active 63.6%) or ‘no change (sham: 33.3% vs. active 36.4%) respectively. After phase 2, significant positive effects were observed for most of the outcomes, and 78.8% of patients reported improvement according to CGI‐C.ConclusionsThis study suggests the clinical benefits of the EXOPULSE Mollii Suit in alleviating pain and fibromyalgia‐related fatigue, emotional symptoms, and disease impact. It is worth noting that the study has several limitations related to the low number of participants, the short‐term analysis of effects in the first blinded and controlled phase, and the open‐label nature of phase 2. Future studies with a larger cohort and longer protocol treatment are needed, to further confirm the current results, and evaluate the long‐term effects of this technique.SignificancePatients with fibromyalgia suffer from pain as well as fatigue, sleep impairment, emotional disturbances, and altered quality of life. Transcutaneous electrical nerve stimulation might help manage those symptoms, but the available systems are limited by the fact that they could be applied at best over two sites. This randomized controlled study is the first to apply a multi‐site transcutaneous electrical nerve stimulation device, the EXOPULSE Mollii Suit, with significant effects on fibromyalgia pain and related symptoms.
Introduction Meta-analytic findings and clinical practice guidance recommend pharmacological (e.g., pregabalin, duloxetine, and milnacipran) and non-pharmacological (e.g., exercise and sleep hygiene) interventions to reduce symptoms and improve quality of life in people living with fibromyalgia. However, some of these therapies may lack robust evidence as to their efficacy, have side effects that may outweigh benefits, or carry risks. Although the annual prevalence of fibromyalgia in active duty service members was estimated to be 0.015% in 2018, the likelihood of receiving a fibromyalgia diagnosis was 9 times greater in patients assigned female than male and twice as common in non-Hispanic Black than White service members. Therefore, the primary goal of this retrospective study is to examine co-occurring conditions and pain-management care receipt in the 3 months before and 3 months after fibromyalgia diagnosis in active duty service members from 2015 to 2022. Materials and Methods Medical record information from active duty service members who received a fibromyalgia diagnosis between 2015 and 2022 in the U.S. Military Health System was included in the analyses. Bivariate analyses evaluated inequities in co-occurring diagnoses (abdominal and pelvic pain, insomnia, psychiatric conditions, and migraines), health care (acupuncture and dry needling, biofeedback and other muscle relaxation, chiropractic and osteopathic treatments, exercise classes and activities, massage therapy, behavioral health care, other physical interventions, physical therapy, self-care management, and transcutaneous electrical nerve stimulation), and prescription receipt (anxiolytics, gabapentinoids, muscle relaxants, non-opioid pain medication, opioids, selective serotonin and norepinephrine inhibitors, and tramadol) across race and ethnicity and assigned sex. Pairwise comparisons were made using a false discovery rate adjusted P value. Results Overall, 13,663 service members received a fibromyalgia diagnosis during the study period. Approximately 52% received a follow-up visit within 3 months of index diagnosis. Most service members received a co-occurring psychiatric diagnosis (35%), followed by insomnia (24%), migraines (20%), and abdominal and pelvic pain diagnoses (19%) fibromyalgia diagnosis. At least half received exercise classes and activities (52%), behavioral health care (52%), or physical therapy (50%). Less commonly received therapies included other physical interventions (41%), chiropractic/osteopathic care (40%), massage therapy (40%), transcutaneous electrical nerve stimulation (33%), self-care education (29%), biofeedback and other muscle relaxation therapies (22%), and acupuncture or dry needling (14%). The most common prescriptions received were non-opioid pain medications (72%), followed by muscle relaxers (44%), opioids (32%), anxiolytics (31%), gabapentinoids (26%), serotonin-norepinephrine reuptake inhibitor (21%), selective serotonin reuptake inhibitors (20%), and tramadol (15%). There were many inequities identified across outcomes. Conclusion Overall, service members diagnosed with fibromyalgia received variable guideline-congruent health care within the 3 months before and after fibromyalgia diagnosis. Almost 1 in 3 service members received an opioid prescription, which has been explicitly recommended against use in guidelines. Pairwise comparisons indicated unwarranted variation across assigned sex and race and ethnicity in both co-occurring health conditions and care receipt. Underlying reasons for health and health care inequities can be multisourced and modifiable. It is unclear whether the U.S. Military Health System has consolidated patient resources to support patients living with fibromyalgia and if so, the extent to which such resources are accessible and known to patients and their clinicians.
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