NCT03595241

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

Prospective, Randomised, Crossover, Controlled, Feasibility Study to Assess the Efficacy of BurstDR Spinal Cord Stimulation (SCS) as a Treatment for Persistent AbdomiNal RefrActory VisCEral PAin Secondary to Chronic Pancreatitis: PANACEA Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Detailed description

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

• Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-09
• Primary completion: 2020-07-01
• Completion: 2021-12-01
• First posted: 2018-07-23
• Last updated: 2019-01-28

Locations

1 site across 1 country: United Kingdom