Dataset Information

[Clinical efficacy of auricular vagus nerve stimulation in the treatment of chronic and acute pain : A systematic review].

ABSTRACT:

Background

Current guidelines recommend a personalized, multimodal, and interdisciplinary approach for the treatment of chronic pain. Already in the acute treatment of postoperative pain, it can be useful to minimize risk factors for chronification. Auricular vagus nerve stimulation (aVNS) could be an effective non-drug therapy for the treatment of chronic and acute pain.

Aim of the work

The aim of this systematic review is to evaluate the clinical efficacy of aVNS in chronic and acute pain as well as its effect on medication intake.

Materials and methods

A systematic literature search was carried out on the application of auricular electrical stimulation in chronic and acute pain. Studies were classified according to their level of evidence and evaluated via the Jadad scale as well as their scientific validity, and then analyzed in terms of indication, method, stimulation parameters, duration of treatment, efficacy, and safety.

Results

Twenty studies on chronic pain indications, ten studies on acute postoperative pain, as well as seven studies on experimental acute pain were identified and analyzed. The search revealed a total of n = 1105 aVNS-treated patients. The best evidence on the efficacy of aVNS is available for the indications chronic low back pain, chronic cervical syndrome, chronic abdominal pain, and chronic migraine as well as acute postoperative pain in oocyte aspiration, laparoscopic nephrectomy, and open colorectal surgery. Additionally a significant reduction in analgesic or opiate intake was evident in most studies. In three randomized controlled trials in chronic pain patients, a sustainable pain reduction over a period of up to 12 months was shown. Overall, aVNS was very well tolerated.

Conclusion

This review indicates that aVNS can be a complementary and effective non-drug treatment for patients with chronic and acute postoperative pain. Future studies in these indications should focus on standardizing and optimizing treatment parameters, inclusion of quality-of-life outcome parameters, and longer follow-up periods to better understand the sustainable therapeutic effect of aVNS.

SUBMITTER: Likar R

PROVIDER: S-EPMC11271441 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

[Clinical efficacy of auricular vagus nerve stimulation in the treatment of chronic and acute pain : A systematic review].

Likar Rudolf R Perruchoud Christophe C Kampusch Stefan S Köstenberger Markus M Sator Sabine S Stremnitzer Caroline C Wolf Andreas A Neuwersch-Sommeregger Stefan S

Schmerz (Berlin, Germany) 20230102 4

<h4>Background</h4>Current guidelines recommend a personalized, multimodal, and interdisciplinary approach for the treatment of chronic pain. Already in the acute treatment of postoperative pain, it can be useful to minimize risk factors for chronification. Auricular vagus nerve stimulation (aVNS) could be an effective non-drug therapy for the treatment of chronic and acute pain.<h4>Aim of the work</h4>The aim of this systematic review is to evaluate the clinical efficacy of aVNS in chronic and ...[more]

PMID: 36592212

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Project description:IntroductionCurrent guidelines for pain treatment recommend a personalized, multimodal and interdisciplinary approach as well as the use of a combination of drug and non-drug therapies. Risk factors for chronification should already be reduced in patients with acute pain, e.g., after surgery or trauma. Auricular vagus nerve stimulation (aVNS) could be an effective non-drug therapy in the multimodal treatment of chronic and acute pain. The aim of this systematic review and meta-analysis is to evaluate the clinical efficacy and safety of aVNS in treating chronic and acute pain conditions.MethodsA systematic literature search was performed regarding the application of auricular electrical stimulation in chronic and acute pain. Studies were classified according to their level of evidence (Jadad scale), scientific validity and risk of bias (RoB 2 tool) and analyzed regarding indication, method, stimulation parameters, duration of treatment and efficacy and safety. A meta-analysis on (randomized) controlled trials (using different comparators) was performed for chronic and acute pain conditions, respectively, including subgroup analysis for percutaneous (pVNS-needle electrodes) and transcutaneous (tVNS-surface electrodes) aVNS. The visual analog pain scale (VAS) was defined as primary efficacy endpoint.ResultsA total of n = 1496 patients were treated with aVNS in 23 identified and analyzed studies in chronic pain, 12 studies in acute postoperative pain and 7 studies in experimental acute pain. Of these, seven studies for chronic pain and six studies for acute postoperative pain were included in the meta-analysis. In chronic pain conditions, including back pain, migraine and abdominal pain, a statistically significant reduction in VAS pain intensity for active compared to sham aVNS or control treatment with an effect size Hedges' g/mean difference of - 1.95 (95% confidence interval [CI]: - 3.94 to 0.04, p = 0.008) could be shown and a more favorable effect in pVNS compared to tVNS (- 5.40 [- 8.94; - 1.85] vs. - 1.00 [- 1.55; - 0.44]; p = 0.015). In acute pain conditions, single studies showed significant improvements with aVNS, e.g., in kidney donor surgery or tonsillectomy but, overall, a non-statistically significant reduction in VAS pain intensity for active compared to sham aVNS or control with - 0.70 [- 2.34; 0.93] (p = 0.15) could be observed in the meta-analysis. In acute pain results vary greatly between studies depending especially on co-medication and timepoints of assessment after surgery. A significant reduction in analgesics or opiate intake was documented in most studies evaluating this effect in chronic and acute pain. In 3 of the 12 randomized controlled trials in patients with chronic pain, a sustainable pain reduction over a period of up to 12 months was shown. Overall, aVNS was very well tolerated.ConclusionThis systematic review and meta-analysis indicate that aVNS can be an effective and safe non-drug treatment in patients with specific chronic and acute postoperative pain conditions. Further research is needed to identify the influence of simulation parameters and find optimal and standardized treatment protocols while considering quality-of-life outcome parameters and prolonged follow-up periods. A more standardized approach and harmonization in study designs would improve comparability and robustness of outcomes.

Project description:ImportanceEvidence from randomized clinical trials of transcutaneous auricular vagus nerve stimulation (taVNS) for chronic insomnia disorder is lacking.ObjectiveTo evaluate the efficacy and safety of taVNS for chronic insomnia compared with the sham taVNS.Design, setting, and participantsThis randomized clinical trial was conducted from October 2021 to December 2022 at a single center in Beijing, China. Patients with chronic insomnia disorder with a Pittsburgh Sleep Quality Index (PSQI) of at least 8 were enrolled. Statistical analysis was performed from June to September 2023.InterventionsPatients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 30 minutes each time, twice a day, 5 consecutive days a week, with an 8-week treatment and a 12-week follow-up.Main outcomes and measuresThe primary end point was the mean change from baseline through week 8 in PSQI scores. Minimal clinically important difference was 2.5 points. Secondary outcomes included mental health, sleepiness, and fatigue. Safety was also evaluated.ResultsA total of 72 participants were randomized to either active taVNS group (36 participants; mean [SD] age, 45.2 [14.5] years; 27 [75.0%] female) or the sham taVNS group (36 participants; mean [SD] age, 44.6 [13.9] years; 31 [86.1%] female); 68 participants completed the 8-week intervention. The least-square mean changes from baseline to week 8 in PSQI were -8.2 (95% CI, -9.3 to -7.0) points in the taVNS group and -3.9 (95% CI, -5.1 to -2.7) points in the sham group. Both groups experienced statistically significant improvements from before to after the intervention. However, active taVNS showed a clinically meaningful 4.2-point greater reduction (95% CI, -5.9 to -2.6 points; P < .001; Cohen d effect size, 1.2) in PSQI compared with the sham group (minimal clinically important difference = 2.5 points). Secondary outcomes, including mental health and fatigue, showed similar favorable results. The efficacy of taVNS was sustained throughout the 20-week study period.Conclusions and relevanceIn this randomized clinical trial, taVNS significantly reduced insomnia severity. Clinically meaningful enhancements in PSQI scores were observed compared with sham stimulation, with the benefits of taVNS sustained over a 20-week period. Future multicenter clinical trials with large sample sizes are needed to validate its effectiveness across diverse populations.Trial registrationChinese Clinical Trial Registry: ChiCTR2100051319.

Project description:ObjectivesTranscutaneous auricular vagus nerve stimulation (taVNS) modulates brain activity and heart function. The induced parasympathetic predominance leads to an increase of heart rate variability (HRV). Knowledge on the corresponding cortical activation pattern is, however, scarce. We hypothesized taVNS-induced HRV increases to be related to modulation of cortical activity that regulates the autonomic outflow to the heart.Materials and methodsIn thirteen healthy subjects, we simultaneously recorded 64-channel electroencephalography and electrocardiography during taVNS. Two taVNS stimulation targets were investigated, i.e., the cymba conchae and inner tragus, and compared to active control stimulation in the anatomical vicinity, i.e., at the crus helicis and outer tragus. We used intermitted stimulation bursts of 25 Hz applied at a periodicity of 1 Hz. HRV was estimated with different time-domain methodologies: standard deviation of RR (SDNN), the root mean squares of successive differences (RMSSD), the percentage of RR-intervals with at least 50 ms deviation from the preceding RR-interval (pNN50), and the difference of consecutive RR intervals weighted by their mean (rrHRV).ResultsThe stimulation-induced HRV increases corresponded to frequency-specific oscillatory modulation of different cortical areas. All stimulation targets induced power modulations that were proportional to the HRV elevation. The most prominent changes that corresponded to HRV increases across all parameters and stimulation locations were frontal elevations in the theta-band. In the delta-band, there were frontal increases (RMSSD, pNN50, rrHRV, SDNN) and decreases (SDNN) across stimulation sites. In higher frequencies, there was a more divers activity pattern: Outer tragus/crus helicis stimulation increased oscillatory activity with the most prominent changes for the SDNN in frontal (alpha-band, beta-band) and fronto-parietal (gamma-band) areas. During inner tragus/cymba conchae stimulation the predominant pattern was a distributed power decrease, particularly in the fronto-parietal gamma-band.ConclusionNeuro-cardiac interactions can be modulated by electrical stimulation at different auricular locations. Increased HRV during stimulation is correlated with frequency-specific increases and decreases of oscillatory activity in different brain areas. When applying specific HRV measures, cortical patterns related to parasympathetic (RMSSD, pNN50, rrHRV) and sympathetic (SDNN) modulation can be identified. Thus, cortical oscillations may be used to define stimulation locations and parameters for research and therapeutic purposes.

Project description:Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.

Dataset Information

[Clinical efficacy of auricular vagus nerve stimulation in the treatment of chronic and acute pain : A systematic review].

Background

Aim of the work

Materials and methods

Results

Conclusion

Publications

[Clinical efficacy of auricular vagus nerve stimulation in the treatment of chronic and acute pain : A systematic review].

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