Evidence map›Paper›PMID 39828740›Full record

Trial reportBMC musculoskeletal disorders2025

Transcutaneous vagus nerve stimulation as a pain modulator in knee osteoarthritis: a randomized controlled clinical trial.

Gehad Gamal Elsehrawy, Maha Emad Ibrahim, Nermeen Hassan A Moneim, Mohamed Ahmed Hefny, Nashwa Kamel El Shaarawy

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05387135 (Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 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.

NCT05387135 nacompletednot on this map

Transcutaneous Vagus Nerve Stimulation As a Pain Modulator in Knee Osteoarthritis

TypeinterventionalSponsorSuez Canal UniversityRan2019 to 2022Enrolled68ConditionsKnee OsteoarthritisArmsTranscutaneous Vagus Nerve Stimulation
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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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

5 authors.

Gehad Gamal ElsehrawyDepartment of Physical Medicine, Rheumatology and Rehabilitation, faculty of medicine, Suez Canal University, Ismailia, 41522, Egypt. gehadgamal@med.suez.edu.eg.ORCID http://orcid.org/0000-0002-1447-0543
Maha Emad IbrahimDepartment of Physical Medicine, Rheumatology and Rehabilitation, faculty of medicine, Suez Canal University, Ismailia, 41522, Egypt.
Nermeen Hassan A MoneimDepartment of Physical Medicine, Rheumatology and Rehabilitation, faculty of medicine, Suez Canal University, Ismailia, 41522, Egypt.
Mohamed Ahmed HefnyDepartment of Physical Medicine, Rheumatology and Rehabilitation, faculty of medicine, Suez Canal University, Ismailia, 41522, Egypt.
Nashwa Kamel El ShaarawyDepartment of Physical Medicine, Rheumatology and Rehabilitation, faculty of medicine, Suez Canal University, Ismailia, 41522, Egypt.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOur understanding of osteoarthritis (OA) has evolved from a degenerative disease to one in which low-grade, chronic inflammation plays a central role. In addition, evidence suggests that OA is accompanied by both peripheral and central nervous system sensitization that can cause pain. It has been demonstrated that transcutaneous vagus nerve stimulation (tVNS) can relieve pain, inflammation, and central sensitization in other conditions including fibromyalgia, pelvic pain, and headaches. We aimed to assess the efficacy and safety of tVNS on nociceptive pain, central sensitization, and physical function in knee OA.

methodsIn this 12-week study, we stimulated the auricular branch of the vagus nerve with an auricular electrode connected to a transcutaneous electrical nerve stimulation device once a day for 3 days each week for 12 weeks. A total of 68 patients with chronic knee OA were randomly assigned to the active and sham groups (34 patients in each group). We used a variety of outcome measures, including the visual analog scale (VAS), pressure pain threshold (PPT), knee injury and osteoarthritis outcome score (KOOS), PainDETECT (PD-Q) and Douleur Neuropathique 4 (DN4) questionnaires. Outcome measures were recorded at baseline, At the end of the stimulation period, and then after 4 weeks.

resultsIn the active group, compared to baseline, there was a significant improvement in VAS scores between the first and second follow-up visits (P < 0.001). A significant improvement in PPT was seen in the right knee, left knee, and right elbow in active tVNS, and this improvement persisted for four weeks post-intervention. Meanwhile, in the sham group, right knee PPT was improved but not maintained. There were statistically significant improvements in the PD-Q and DN4 scores in the active tVNS group (P < 0.001), whereas in the sham group, DN4 questionnaire did not show any improvement. In terms of functional outcomes, the improvement in KOOS was significant only in the active group (31.44 ± 18.49, P < 0.001). No serious adverse events were observed.

conclusionThere is preliminary evidence to support the benefits of tVNS in OA, suggesting that neuromodulation can be used as an adjunct to existing pharmacological and non-pharmacological treatments.

trial registrationThe study was registered on ClinicalTrials.gov (NCT05387135) on 24/05/2022.

Indexed as

Osteoarthritis, KneePain ManagementTranscutaneous Electric Nerve StimulationVagus Nerve StimulationAgedFemaleHumansMaleMiddle AgedPain MeasurementPain ThresholdTreatment OutcomeCentral sensitizationFunctional outcomesOsteoarthritisTranscutaneous vagus nerve stimulation

Identifiers

PMID39828740
PMCPMC11744843

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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.