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Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial.

作者信息

Courties Alice, Deprouw Camille, Rousseau Alexandra, Berard Laurence, Touati Amel, Kalsch Johanna, Villevieille Margaux, Maheu Emmanuel, Miquel Anne, Simon Tabassome, Berenbaum Francis, Sellam Jeremie

机构信息

Sorbonne Universite, Paris, France.

Hôpital Saint-Antoine, Service de Rhumatologie, Centre de Recherche Saint-Antoine, INSERM UMR_S 938, APHP, Paris, France.

出版信息

BMJ Open. 2022 Mar 22;12(3):e056169. doi: 10.1136/bmjopen-2021-056169.


DOI:10.1136/bmjopen-2021-056169
PMID:35318234
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8943744/
Abstract

INTRODUCTION: Patients with erosive hand osteoarthritis (EHOA) experience pain and inflammation, two features that can be targeted by vagus nerve stimulation using electrical auricular transcutaneous vagus nerve stimulation (tVNS). A pilot study demonstrated the feasibility of the procedure, so we designed a randomised sham-controlled trial to determine the safety and efficacy of tVNS in EHOA. METHODS AND ANALYSIS: ESTIVAL Study (Essai randomisé comparant la STImulation auriculaire transcutanée du nerf Vague versus sham stimulation dans l'Arthrose DigitaLe Érosive symptomatique et inflammatoire) is a superiority, randomised, double-blind sham-controlled trial comparing two parallel arms: active and sham tVNSs in a 1:1 ratio. Patients with symptomatic EHOA (score ≥40/100 mm on a visual analogue scale (VAS) for pain of 0-100 mm) and inflammatory EHOA (≥1 clinical and ultrasonography-determined interphalangeal synovitis) are included in 18 hospital centres (17 rheumatology and 1 rehabilitation departments) in France. Active and sham tVNSs use an auricular electrode connected to the Vagustim device, with no electric current delivered in the sham group. Patients undergo stimulation for 20 min/day for 12 weeks. The follow-up visits take place at weeks 4, 8 and 12. The enrolment duration is 2 years and started in April 2021; 156 patients are scheduled to be included. The primary outcome is the difference in self-reported hand pain in the previous 48 hours measured on a VAS of 0-100 mm between baseline and week 12. Secondary outcomes include other pain outcomes, function, quality of life, serum biomarker levels, compliance and tolerance. For a subset of patients, MRI of the hand is performed at baseline and week 12 to compare the change in Outcome Measures in Rheumatology/Hand Osteoarthritis MRI Scoring System subscores. The primary analysis will be performed at the end of the study according to the intent-to-treat principle. ETHICS AND DISSEMINATION: Ethics approval was obtained from the institutional review board (Comité de Protection des Personnes, 2020-A02213-36). All participants will be required to provide written informed consent. The findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04520516; Pre-results. PROTOCOL VERSION AND NUMBER: V.2 of 11 March 2021.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0aa/8943744/ad8c31fa21e1/bmjopen-2021-056169f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0aa/8943744/1a1d9d4c68de/bmjopen-2021-056169f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0aa/8943744/ad8c31fa21e1/bmjopen-2021-056169f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0aa/8943744/1a1d9d4c68de/bmjopen-2021-056169f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0aa/8943744/ad8c31fa21e1/bmjopen-2021-056169f02.jpg

相似文献

[1]
Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial.

BMJ Open. 2022-3-22

[2]
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引用本文的文献

[1]
Vagus nerve stimulation: innovative applications in the field of hand function rehabilitation.

Cogn Neurodyn. 2025-12

[2]
Erosive Hand Osteoarthritis: Recent Advances and Future Treatments.

Curr Rheumatol Rep. 2024-4

本文引用的文献

[1]
Effect of Transcutaneous Vagus Nerve Stimulation in Erosive Hand Osteoarthritis: Results from a Pilot Trial.

J Clin Med. 2022-2-18

[2]
The DIGICOD cohort: A hospital-based observational prospective cohort of patients with hand osteoarthritis - methodology and baseline characteristics of the population.

Joint Bone Spine. 2021-7

[3]
Vagus nerve stimulation in musculoskeletal diseases.

Joint Bone Spine. 2021-5

[4]
Colchicine is not effective for reducing osteoarthritic hand pain compared to placebo: a randomised, placebo-controlled trial (COLAH).

Osteoarthritis Cartilage. 2021-2

[5]
Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial.

Ann Rheum Dis. 2021-3

[6]
Investigational treatment of rheumatoid arthritis with a vibrotactile device applied to the external ear.

Bioelectron Med. 2019-4-17

[7]
Results of a 6-week treatment with 10 mg prednisolone in patients with hand osteoarthritis (HOPE): a double-blind, randomised, placebo-controlled trial.

Lancet. 2019-11-11

[8]
Etanercept in patients with inflammatory hand osteoarthritis (EHOA): a multicentre, randomised, double-blind, placebo-controlled trial.

Ann Rheum Dis. 2018-10-3

[9]
Brain Structural Alterations in Chronic Knee Osteoarthritis: What Can Treatment Effects Teach Us?

Pain Med. 2018-11-1

[10]
Recent advances in devices for vagus nerve stimulation.

Expert Rev Med Devices. 2018-8-17

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