The Impact of Auricular Vagus Nerve Stimulation on Pain and Life Quality in Patients with Fibromyalgia Syndrome

Abstract

The purpose of this study is to evaluate the impact of auricular vagus nerve stimulation, applied in conjunction with an exercise treatment program, on pain and life quality in patients with fibromyalgia syndrome (FMS). To achieve the study objectives, 60 female patients between the ages 18 and 50, with diagnosed FMS according to the American College of Rheumatology (ACR) 2010 diagnostic criteria, were randomly divided into 2 groups of 30. The first group was assigned 20 sessions of a home-based exercise program, while the second group was assigned 20 sessions of auricular vagus nerve stimulation and 20 sessions of a home-based exercise program. Patients were assessed before and after the treatments using the Visual Analog Scale (VAS) for pain, Beck Depression Scale for depression, Beck Anxiety Scale for anxiety, Fibromyalgia Impact Questionnaire (FIQ) for functional evaluation, and Short Form-36 (SF-36) for life quality. In this randomized controlled trial, comparisons within the groups revealed that both groups had statistically significant improvements in pain, depression, anxiety, functionality, and life quality scores (p < 0:05), while comparisons across the groups revealed that the group experiencing the vagus nerve stimulation had no statistically significant differences between the baseline scores, except for those of SF-36's subparameters of physical function, social functionality, and pain. In fact, comparisons across the groups after the interventions revealed that the group experiencing the vagus nerve stimulation had better scores but not statistically significant. From analysis of this data, we observed that vagus nerve stimulation in FMS treatment did not give additional benefit together with exercise, except for three subparameters of SF-36. It was identified that further studies which separately investigate the effects of vagus nerve stimulation and exercise on FMS with longer follow-up periods and an increased number of patients are needed.

Klinische Wirksamkeit der aurikulären Vagusnervstimulation in der Behandlung chronischer und akuter Schmerzen

“…1 -und Kontrolle), Stimulationsparameter, Behandlungsdauer, primäre und sekundäre Ergebnisse sowie beobachtete unerwünschte Ereignisse. [30,40,41,49,53,64,69], n = 154), Migräne (4 Studien [24,39,70,84], n = 133), Rückenschmerz (4 Studien [39,65,66,71], n = 192), rheumatoide Arthritis (RA)/Osteoarthritis (2 Studien [17,46]; n = 45), Fibromyalgie/ systemischer Lupus Erythematodes (SLE) (3 Studien [5,43,79], n = 51), Chemotherapie-induzierte periphere Neuropathie (1 Studie [62]; n = 58), unspezifischer chronischer Schmerz (1 Studie [30], n = 3). Von diesen waren 9 Studien [5,40,41,43,65,66,69,70,84] Schmerz auf einer Visuellen Analogskala (VAS) oder Numerischen Rating-Skala (NRS), psychisches Wohlbefinden und Verträglichkeit/Sicherheit der Stimulation waren die häufigsten primären und sekundären Endpunkte.…”

Efficacy of nonpharmacological interventions for individual features of fibromyalgia: a systematic review and meta-analysis of randomised controlled trials

“…86 Studies were analysed separately based on their comparison types, namely, usual care, placebo or sham controlled, and A 1 B vs B designed studies. For the purpose of this review A 1 B vs B study designs were defined as studies that compared 2 interventions that were offered actively against a single intervention, for example, Relton et al (2009), Kibar et al (2015), Kutlu et al (2020), etc. Studies that evaluated an intervention against continued usual care, waiting list, or no treatment were not considered as A 1 B designs for the purpose of this review as continued usual care would be available to participants on wait list or those not being offered any additional treatment in the trial and also to participants in the intervention arm.…”

Non-Invasive Transcutaneous Vagus Nerve Stimulation for the Treatment of Fibromyalgia Symptoms: A Study Protocol

“…Since fibromyalgia involves a dysregulation of the autonomic (high sympathetic tone) and immune (enhanced pro-inflammatory activity) systems [ 25 , 41 ], non-invasive tVNS is expected to improve the symptoms of fibromyalgia, including chronic, musculoskeletal, and generalized pain [ 42 , 43 ], through modulation of the vegetative and immune systems [ 44 ]. The main objective of this intervention study is to evaluate the effects of repeated sessions of tVNS on pain and other symptoms in fibromyalgia patients, comparing auricular and cervical tVNS protocols which have been probed in other pathologies [ 45 , 46 , 47 , 48 , 49 ].…”