Evidence map›Paper›PMID 22568773›Full record

Trial reportPain medicine (Malden, Mass.)2012

Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation.

Vitaly Napadow, Robert R Edwards, Christine M Cahalan, George Mensing, Seth Greenbaum, Assia Valovska, Ang Li, Jieun Kim, Yumi Maeda, Kyungmo Park and 1 more

5 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pain medicine (Malden, Mass.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 96 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02540512 early_phase1withdrawnnot on this mapstarted 2017, after this paper: background citation

Auricular Acupuncture for the Acute Management of Pain in the Emergency Department

TypeinterventionalSponsorLoma Linda UniversityRan2017 to 2017Enrolled0ConditionsMusculoskeletal Pain, PainArmsAuricular Acupuncture, Acupuncture, Placebo Acupuncture, hydrocodone / acetaminophen 5mg/325mg, Placebo Pill
NCT03440255 nacompletednot on this mapstarted 2017, after this paper: background citation

Transcutaneous Vagus Nerve Stimulation (TaVNS) in Private Healthcare Center: An Open-Label, Non-Randomized Feasibility Study Targeting Anxiety, Chronic Pain and Irritable Bowel Syndrome

TypeinterventionalSponsorKinesis Health AssociatesRan2017 to 2017Enrolled11ConditionsGeneralized Anxiety Disorder, Chronic Pain, Irritable Bowel SyndromeArmsTranscutaneous Vagus Nerve Stimulation
NCT04632134 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Symptoms and Cardiovascular Autonomic Profile of Patients With Postural Orthostatic Tachycardia Syndrome (POTS)

TypeinterventionalSponsorIstituto Clinico HumanitasRan2019 to 2022Enrolled23ConditionsOrthostatic Intolerance, Postural Tachycardia Syndrome, Syncope, Postural, Physical DisabilityArmsTranscutaneous vagal nerve stimulation (tVNS), Placebo, Home daily transcutaneous vagal nerve stimulation
NCT04938687 completednot on this mapstarted 2022, after this paper: background citation

Pilot, Effect of Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) on Post-Treatment Lyme Disease Syndrome

TypeinterventionalSponsorSpaulding Rehabilitation HospitalRan2022 to 2025Enrolled15ConditionsPost-Treatment Lyme Disease SyndromeArmsrespiratory-gated auricular vagal afferent nerve stimulation (RAVANS), Sham RAVANS
NCT07498881 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

LasaiOn: An Intervention Program to Reduce Emotional Distress

TypeinterventionalSponsorUniversity of the Basque Country (UPV/EHU)Ran2026 to 2028Enrolled200ConditionsAdultArmsLasaiON
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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36 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Vitaly NapadowMartinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Charlestown, MA, USA. vitaly@nmr.mgh.harvard.edu
Robert R Edwards
Christine M Cahalan
George Mensing
Seth Greenbaum
Assia Valovska
Ang Li
Jieun Kim
Yumi Maeda
Kyungmo Park
Ajay D Wasan

Funding

The Role of Context Effect in Acupuncture Treatment of Low Back/J.KongP01AT006663 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI HIRSCHTICK, RANDY L, ROSEN, BRUCE R · 2011 to 2017
$10.0M
Project 3P01AT002048 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI ROSEN, BRUCE R · 2003 to 2010
$8.5M
Brain Plasticity in Carpal Tunnel Syndrome and its Response to AcupunctureR01AT004714 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI NAPADOW, VITALY · 2008 to 2012
$4.5M
Biobehavioral Risk Factors for Persistent Pain following Total Knee ArthroplastyR01AG034982 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI EDWARDS, ROBERT R · 2010 to 2014
$3.2M
Oral Opioid Treatment and Psychiatric ComorbidityK23DA020681 · NIDA · BRIGHAM AND WOMEN'S HOSPITAL · PI WASAN, AJAY D · 2007 to 2011
$751k
Catastrophizing and Cytokine Responses to Acute Pain in the Rheumatic DiseasesR21AR057920 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI EDWARDS, ROBERT R · 2010 to 2011
$431k
FMRI of Autonomic Regulation with AcupunctureF05AT003770 · NCCIH · MASSACHUSETTS GENERAL HOSPITAL · PI PARK, KYUNGMO · 2006 to 2010
$258k
NCCIH NIH HHS F05 AT003770NCCIH NIH HHS F05-AT003770NCCIH NIH HHS P01 AT002048NCCIH NIH HHS P01-AT002048NCCIH NIH HHS P01 AT006663NCCIH NIH HHS R01 AT004714NCCIH NIH HHS R01-AT004714NIAMS NIH HHS R21 AR057920NIAMS NIH HHS R21-AR057920NIA NIH HHS R01 AG034982NIA NIH HHS R01-AG034982NIDA NIH HHS K23 DA020681NIDA NIH HHS K23-DA020681
6 · The paper itself

Abstract

objectivePrevious vagus nerve stimulation (VNS) studies have demonstrated antinociceptive effects, and recent noninvasive approaches, termed transcutaneous-vagus nerve stimulation (t-VNS), have utilized stimulation of the auricular branch of the vagus nerve in the ear. The dorsal medullary vagal system operates in tune with respiration, and we propose that supplying vagal afferent stimulation gated to the exhalation phase of respiration can optimize t-VNS.

designCounterbalanced, crossover study. PATIENTS: Patients with chronic pelvic pain (CPP) due to endometriosis in a specialty pain clinic. INTERVENTIONS/OUTCOMES: We evaluated evoked pain analgesia for respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) compared with nonvagal auricular stimulation (NVAS). RAVANS and NVAS were evaluated in separate sessions spaced at least 1 week apart. Outcome measures included deep-tissue pain intensity, temporal summation of pain, and anxiety ratings, which were assessed at baseline, during active stimulation, immediately following stimulation, and 15 minutes after stimulus cessation.

resultsRAVANS demonstrated a trend for reduced evoked pain intensity and temporal summation of mechanical pain, and significantly reduced anxiety in N = 15 CPP patients, compared with NVAS, with moderate to large effect sizes (η(2) > 0.2).

conclusionChronic pain disorders such as CPP are in great need of effective, nonpharmacological options for treatment. RAVANS produced promising antinociceptive effects for quantitative sensory testing (QST) outcomes reflective of the noted hyperalgesia and central sensitization in this patient population. Future studies should evaluate longer-term application of RAVANS to examine its effects on both QST outcomes and clinical pain.

Indexed as

AdultChronic PainCross-Over StudiesEndometriosisExhalationFemaleHumansMiddle AgedPelvic PainPilot ProjectsTranscutaneous Electric Nerve StimulationVagus Nerve StimulationYoung Adult

Identifiers

PMID22568773
PMCPMC3376238

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.