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Study protocol for a randomised double-blinded, sham-controlled, prospective, cross-over clinical trial of vagal neuromodulation for pain treatment in patients with chronic pancreatitis
  1. Janusiya Anajan Muthulingam1,2,
  2. Søren Schou Olesen2,3,
  3. Tine Maria Hansen1,2,
  4. Christina Brock2,4,
  5. Asbjørn Mohr Drewes2,3,
  6. Jens Brøndum Frøkjær1,2
  1. 1 Mech-Sense, Department of Radiology, Aalborg University Hospital, Aalborg, Denmark
  2. 2 Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
  3. 3 Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, Denmark
  4. 4 Aalborg University Hospital, Aalborg, UK
  1. Correspondence to Professor Jens Brøndum Frøkjær; jebf{at}rn.dk

Abstract

Introduction The management of chronic pancreatitis (CP) is challenging and requires a personalised approach focused on the individual patient’s main symptoms. Abdominal pain is the most prominent symptom in CP, where central pain mechanisms, including sensitisation and impaired pain modulation, often are involved. Recent clinical studies suggest that vagal nerve stimulation (VNS) induces analgesic effects through the modulation of central pain pathways. This study aims to investigate the effect of 2 weeks transcutaneous VNS (t-VNS) on clinical pain in patients with CP, in comparison to the effect of sham treatment.

Methods and analysis Twenty-one patients with CP will be enrolled in this randomised, double-blinded, single-centre, sham-controlled, cross-over study. The study has two treatment periods: A 2-week active t-VNS using GammaCore device and a 2-week treatment with a sham device. During both treatment periods, the patients are instructed to self-administer VNS bilaterally to the cervical vagal area, three times per day. Treatment periods will be separated by 2 weeks. During the study period, patients will record their daily pain experience in a diary (primary clinical endpoint). In addition, all subjects will undergo testing which will include MRI, quantitative sensory testing, cardiac vagal tone assessment and collecting blood samples, before and after the two treatments to investigate mechanisms underlying VNS effects. The data will be analysed using the principle of intention to treat.

Ethics and dissemination The regional ethics committee has approved the study: N-20170023. Results of the trial will be submitted for publication in peer-reviewed journals.

Trial registration number The study is registered at www.clinicaltrials.gov: NCT03357029.

  • viscera
  • clinical trials
  • gastrointestinal disease
  • chronic pain
  • transcutaneous electrical nerve stimulation

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors All authors conceived and designed the study and participated in the logistical planning of the study. JAM drafted the initial version of the manuscript and is collecting the data. All authors made significant contributions to the development and conceptualisation of the protocol. All authors reviewed the draft versions of the manuscript and have read and approved the final manuscript.

  • Funding The study is conducted as a sponsor-investigator initiated study with financial support from Independent Research Fund Denmark (DFF: 7016-00073).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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