TY - JOUR
T1 - 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
AU - Muthulingam, Janusiya Anajan
AU - Olesen, Søren Schou
AU - Hansen, Tine Maria
AU - Brock, Christina
AU - Drewes, Asbjørn Mohr
AU - Frøkjær, Jens Brøndum
PY - 2019/8
Y1 - 2019/8
N2 - 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.
AB - 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.
KW - chronic pain
KW - clinical trials
KW - gastrointestinal disease
KW - transcutaneous electrical nerve stimulation
KW - viscera
UR - http://www.scopus.com/inward/record.url?scp=85073104581&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-029546
DO - 10.1136/bmjopen-2019-029546
M3 - Journal article
C2 - 31603076
SN - 2044-6055
VL - 9
SP - 1
EP - 9
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e029546
ER -