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Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis

A Sham-Controlled, Randomized Trial of Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06230120
Enrollment
16
Registered
2024-01-30
Start date
2020-11-01
Completion date
2022-12-31
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Chronic Pancreatitis

Keywords

Pain, Chronic Pancratitis, Pancreatitis, Spinal Cord Stimulation

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.

Interventions

DEVICESpinal Cord Stimulation

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

DEVICESham

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

Sponsors

Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain reliefAt baseline and days 7-10 in each stimulation periodThe 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.

Secondary

MeasureTime frameDescription
The modified Brief Pain Inventory short-form (mBPI-sf)At baseline an immediately after the interventionDifferences in the pain and functioning composite scores of the modified Brief Pain Inventory short-form between stimulation period (SCS vs sham)
Patient Global Impression of Change (PGIC)Immediately after the interventionThe Patient Global Impression of Change assessed after each stimulation period
Comprehensive Pain Assessment Tool short-form (COMPAT-sf)At baseline an immediately after the interventionDifferences in the Comprehensive Pain Assessment Tool short-form (COMPAT-sf) total score and subscroes between stimulation periods (SCS vs sham)
Quality of life using SF 36 (short form 36 health survey)At baseline an immediately after the interventionDifferences in the SF 36 (short form 36 health survey) total score and subscores between stimulation periods (SCS vs sham)
Symptoms of depression and anxiety as documented by the Hospital Anxiety and Depression Scale (HADS)At baseline an immediately after the interventionDifferences in the depression and anxiety scores of Symptoms of depression and anxiety as documented by the Hospital Anxiety and Depression Scale (HADS) between stimulation periods (SCS vs sham)

Other

MeasureTime frameDescription
Quantitative sensory testing: Cold pressor testAt baseline an immediately after the interventionCold pressor endurance time (seconds)
Quantitative sensory testing: Conditioned pain modulationAt baseline an immediately after the interventionRelative change in pressure tolerance threshold before and after cold pressor test (%)
Quantitative sensory testing: Repetitive pinprick stimulationAt baseline an immediately after the interventionDifference in pain scores (VAS) between 1st and 10th stimulus
Quantitative sensory testing: Pressure algometryAt baseline an immediately after the interventionPain detection and tolerance thresholds (kPa)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026