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PANACEA Feasibility Study to Assess the Efficacy of BurstDR Spinal Cord Stimulation (SCS)

NCT03595241 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-28

No results posted yet for this study

Summary

To evaluate the effectiveness of Burst DR stimulation as a treatment for persistent abdominal refractory visceral pain secondary to chronic pancreatitis. Abdominal pain is a main symptom in patients with chronic pancreatitis. Patients have a background constant pain with acute episodes needing admissions. Spinal cord stimulation (SCS) is a recognised treatment for neuropathic pain. This involves placing an electric wire in the spine and the use of electricity to manage the pain. This is a pacemaker for controlling pain. Burst DR stimulation delivers a wave form which mimics the way nerves conduct electrical signals, there are short bursts or spikes of stimulation followed by short periods of rest. The key aims and objectives of this study are to evaluate the efficacy of Burst DR SCS as a treatment for persistent pain secondary to chronic pancreatitis

Conditions

Interventions

DEVICE

Spinal cord stimulation by implanted device.

Spinal cord stimulation (SCS) protocol from the implanted device. This involves activation of the device for the (SCS) protocol including Burst DR therapy.

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2020-07-01
Completion
2021-12-01

Countries

  • United Kingdom

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 NCT03595241 on ClinicalTrials.gov