Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis

NCT ID: NCT06230120

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-12-31

Brief 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.

Detailed Description

Chronic pancreatitis (CP) is a condition causing considerable morbidity, with nearly 0.5 million new cases emerging in Europe every year. It is characterized by a fibro-inflammatory process that progressively damages the pancreas. As the disease advances, most patients experience exocrine pancreatic insufficiency and diabetes, but the most debilitating aspect is severe abdominal pain, which affects about 70% of patients. The pain's origins in CP are complex, typically associated with pancreatic inflammation, ductal obstruction, damage to pancreatic nerves due to inflammation and fibrosis, and resulting neuropathy that triggers sensitization in the pain pathways. This may lead to self-perpetuating pain independent of its initial cause.

Current CP pain management involves conventional analgesics, neuromodulators, and specific endoscopic or surgical interventions for selected cases. However, a substantial number of patients still struggle with inadequate pain relief despite these treatments, necessitating innovative approaches to address CP-associated pain effectively.

Spinal cord stimulation (SCS) is a reversible invasive technique that involves stimulating spinal cord neurons and axons using low-voltage electrical current through leads placed in the epidural space behind the spinal cord dorsal columns. The mechanisms through which neurostimulation may alleviate pain and induce neuroplasticity are intricate and impact multiple neuronal and pain pathways. SCS has shown efficacy in managing neuropathic pain. However, there is a lack of sham-controlled research investigating SCS's effect on visceral pain conditions, including CP.

Hypothesizing that SCS, when compared to sham stimulation, can offer clinically significant pain relief and enhance physical functioning and quality of life in CP patients, an investigator-led, randomized, double-blinded, sham-controlled, cross-over study is initiated.

Conditions

Chronic Pancreatitis; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Spinal Cord Stimulation

A stimulation electrode is placed in the epidural space between the T4-T7 spinal levels and connected to an external electrical pulse generator, which is used for stimulation. The stimulus intensity is initially increased in a ramp-like fashion using high-frequency stimulation at 1000 Hz, with pulse widths of 90 microseconds and intensities increasing from 2 to 14 mA to establish the sensation threshold. After establishing the sensation threshold, the 75 % subthreshold of sensation is used as the stimulation intensity during the active stimulation period.

Group Type: EXPERIMENTAL

Spinal Cord Stimulation

Intervention Type: DEVICE

Stimulation electrode tip (Vectris™ SureScan MRI percutaneous lead, Medtronic Inc, Minneapolis, US)

External electrical pulse generator (Wireless External Neurostimulator System (WENS), Medtronic)

Sham

For sham treatment, a similar procedure for establishing the sensation threshold is used, and stimulation at the 75 % subthreshold intensity is initiated, but the stimulation device is turned off 30 seconds after the sensation subthreshold is established.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

Sham

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Chronic pancreatitis according to the M-ANNHEIM criteria
• Chronic abdominal pain (pain 3=3days per week in at least 3 months)
• Pain insuficiently treated with patients ussual analgesic treatment
• Patients with signs of obstruction of the pancreatic duct due to a stricture or stone have to undergo endoscopic or surgical decompression prior to enrolment

Exclusion Criteria

• Patients suffering from painful conditions other than chronic pancreatitis that made them unable to distinguish the pain associated with chronic pancreatitis
• Patients with ongoing alcohol abuse and illegal drug dependencies

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soren Schou Olesen

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helga A Gulisano, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Department of Gastroenterology, Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

N-20200077

Identifier Type: -

Identifier Source: org_study_id