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Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis

NCT06230120 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-01-30

No results posted yet for this study

Summary

Chronic pancreatitis leads to severe abdominal pain in up to 70% of patients, and several studies have proposed it has a neuropathic component. Current treatments often fail to provide adequate pain relief, necessitating new innovations for management. Spinal cord stimulation has been proposed to treat severe neuropathic pain refractory to conventional treatment, but sham-controlled trials have not previously been done in patients with visceral pain. This study will test the effect of spinal cord stimulation in chronic pancreatitis patients with insufficient pain relief from standard therapies.

Conditions

Interventions

DEVICE

Spinal Cord Stimulation

Stimulation electrode tip (Vectris™ SureScan MRI percutaneous lead, Medtronic Inc, Minneapolis, US) External electrical pulse generator (Wireless External Neurostimulator System (WENS), Medtronic)

DEVICE

Sham

Stimulation electrode tip (Vectris™ SureScan MRI percutaneous lead, Medtronic Inc, Minneapolis, US) with external stimulator turned off

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Helga A Gulisano, MD · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06230120 on ClinicalTrials.gov