Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis

NCT06230120 | Completed Phase 2

• 1 other identifier: N-20200077
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis; Chronic Pain

Keywords

Pain; Chronic Pancratitis; Pancreatitis; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Pain relief

  The difference in pain intensity scores between active and sham stimulations measured using a patient pain diary based on a numeric rating scale where a score of "0" indicated no pain and a score of "10" indicated worst pain imaginable. Pain scores are registered daily for one week prior to intervention and during the two periods of active and sham SCS stimulations.

  At baseline and days 7-10 in each stimulation period

Secondary Outcomes (5)

• Patient Global Impression of Change (PGIC)

  Immediately after the intervention

• The modified Brief Pain Inventory short-form (mBPI-sf)

  At baseline an immediately after the intervention

• Comprehensive Pain Assessment Tool short-form (COMPAT-sf)

  At baseline an immediately after the intervention

• Quality of life using SF 36 (short form 36 health survey)

  At baseline an immediately after the intervention

• Symptoms of depression and anxiety as documented by the Hospital Anxiety and Depression Scale (HADS)

  At baseline an immediately after the intervention

Other Outcomes (4)

• Quantitative sensory testing: Pressure algometry

  At baseline an immediately after the intervention

• Quantitative sensory testing: Repetitive pinprick stimulation

  At baseline an immediately after the intervention

• Quantitative sensory testing: Cold pressor test

  At baseline an immediately after the intervention

Study Arms (2)

Spinal Cord Stimulation

EXPERIMENTAL

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.

Device: Spinal Cord Stimulation

Sham

SHAM COMPARATOR

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.

Device: Sham

Interventions

Spinal Cord Stimulation DEVICE

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

Spinal Cord Stimulation

Sham DEVICE

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

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Department of Gastroenterology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Chronic Pain; Pain; Pancreatitis

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Helga A Gulisano, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 30, 2024
• Study Start: November 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

DK (1)