Feasibility of Auricular Field Stimulation in Fibromyalgia: Evaluation by Functional Magnetic Resonance Imaging, Randomized Trial

Abstract

Objective To evaluate the feasibility of recruitment, preliminary efficacy, and acceptability of auricular percutaneous electrical nerve field stimulation (PENFS) for the treatment of fibromyalgia in veterans, using neuroimaging as an outcome measure and a biomarker of treatment response. Design Randomized, controlled, single-blind. Setting Government hospital. Subjects Twenty-one veterans with fibromyalgia were randomized to standard therapy (ST) control or ST with auricular PENFS treatment. Methods Participants received weekly visits with a pain practitioner over 4 weeks. The PENFS group received reapplication of PENFS at each weekly visit. Resting-state functional connectivity magnetic resonance imaging (rs-fcMRI) data were collected within 2 weeks prior to initiating treatment and 2 weeks following the final treatment. Analysis of rs-fcMRI used a right posterior insula seed. Pain and function were assessed at baseline and at 2, 6, and 12 weeks post-treatment. Results At 12 weeks post-treatment, there was a nonsignificant trend toward improved pain scores and significant improvements in pain interference with sleep among the PENFS treatment group as compared with the ST controls. Neuroimaging data displayed increased connectivity to areas of the cerebellum and executive control networks in the PENFS group as compared with the ST control group following treatment. Conclusions There was a trend toward improved pain and function among veterans with fibromyalgia in the ST + PENFS group as compared with the ST control group. Pain and functional outcomes correlated with altered rs-fcMRI network connectivity. Neuroimaging results differed between groups, suggesting an alternative underlying mechanism for PENFS analgesia.

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.…”

“…In 3 Studien [24,79,84] wurden begleitend zur Therapie fMRI-Untersuchungen durchgeführt, um den Einfluss der aVNS auf die Gehirnaktivität näher zu charakterisieren. Dabei konnte im fMRI ("functional magnetic resonance imaging") insbesondere eine Verstärkung der Gehirnkonnektivität in den Bereichen des exekutiven Kontrollnetzwerks (präfrontale Gehirnregionen), des Thalamus und des Cerebellums unter bzw.…”

Impact of auricular percutaneous electrical nerve field stimulation on gut microbiome in adolescents with irritable bowel syndrome: A pilot study

“…39 Functional brain imaging studies have also shown both acute and long-lasting effects of auricular stimulation by modulating afferent vagal pathways. 45,49,102,103 Taken together, these data suggest that PENFS therapy activates vagal afferent fibers and exerts its positive effects in patients with IBS through modulation of central brain pathways and potentially through an anti-inflammatory pathway. While the current study did not find significant microbial diversity changes within stool samples (α diversity) for the pretreatment group, post-treatment robust or excellent responders, and non-responders, the group defined as "mild responders" displayed a higher α diversity at week 4 compared to week 0 based on the inverse Simpson index.…”

Efficacy of electrophysical agents in fibromyalgia: A systematic review and network meta-analysis

“…The risk of bias assessment for included studies using PEDro scale is presented in Supplemental file, Table S3. Thirty-four studies 38–71 showed a PEDro score >5, 16 studies 36,37,72–85 scored 5, and the remaining four 86–89 scored 4. The overall mean (SD) PEDro score was 6.57 (1.73).…”

“…Forty-seven studies 36,37,39,41–52,54–61,63,65–79,81–88 assessed pain and were eligible for network meta-analysis of pain (Figure 2). When compared to placebo, the consistency model of the network showed that transcutaneous electrical nerve stimulation ( P = 0.006) and microcurrent ( P = 0.037) improved pain symptoms significantly.…”