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NCT Number: NCT06230120

Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Gastroenterology, Aalborg University Hospital

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

SHAM

Device

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

Primary outcomes

  1. Pain relief

    Time frame: At baseline and days 7-10 in each stimulation period

    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.

Secondary outcomes

  1. Patient Global Impression of Change (PGIC)

    Time frame: Immediately after the intervention

    The Patient Global Impression of Change assessed after each stimulation period

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

    Time frame: At baseline an immediately after the intervention

    Differences in the pain and functioning composite scores of the modified Brief Pain Inventory short-form between stimulation period (SCS vs sham)

  3. Comprehensive Pain Assessment Tool short-form (COMPAT-sf)

    Time frame: At baseline an immediately after the intervention

    Differences in the Comprehensive Pain Assessment Tool short-form (COMPAT-sf) total score and subscroes between stimulation periods (SCS vs sham)

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

    Time frame: At baseline an immediately after the intervention

    Differences in the SF 36 (short form 36 health survey) total score and subscores between stimulation periods (SCS vs sham)

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

    Time frame: At baseline an immediately after the intervention

    Differences 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 outcomes

  1. Quantitative sensory testing: Pressure algometry

    Time frame: At baseline an immediately after the intervention

    Pain detection and tolerance thresholds (kPa)

  2. Quantitative sensory testing: Repetitive pinprick stimulation

    Time frame: At baseline an immediately after the intervention

    Difference in pain scores (VAS) between 1st and 10th stimulus

  3. Quantitative sensory testing: Cold pressor test

    Time frame: At baseline an immediately after the intervention

    Cold pressor endurance time (seconds)

  4. Quantitative sensory testing: Conditioned pain modulation

    Time frame: At baseline an immediately after the intervention

    Relative change in pressure tolerance threshold before and after cold pressor test (%)

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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