Clinical trial NCT06230120: Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis
Official title: A Sham-Controlled, Randomized Trial of Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pancreatitis
Chronic Pain
Keywords: Pain
Chronic Pancratitis
Pancreatitis
Spinal Cord Stimulation
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain relief
timeFrame: At baseline and days 7-10 in each stimulation period
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: Immediately after the intervention
measure: The modified Brief Pain Inventory short-form (mBPI-sf)
timeFrame: At baseline an immediately after the intervention
measure: Comprehensive Pain Assessment Tool short-form (COMPAT-sf)
timeFrame: At baseline an immediately after the intervention
measure: Quality of life using SF 36 (short form 36 health survey)
timeFrame: At baseline an immediately after the intervention
measure: Symptoms of depression and anxiety as documented by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline an immediately after the intervention
Other outcomes:
measure: Quantitative sensory testing: Pressure algometry
timeFrame: At baseline an immediately after the intervention
measure: Quantitative sensory testing: Repetitive pinprick stimulation
timeFrame: At baseline an immediately after the intervention
measure: Quantitative sensory testing: Cold pressor test
timeFrame: At baseline an immediately after the intervention
measure: Quantitative sensory testing: Conditioned pain modulation
timeFrame: At baseline an immediately after the intervention
Locations:
city: Aalborg
country: Denmark
facility: Department of Gastroenterology, Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Helga A Gulisano, MD
role: PRINCIPAL_INVESTIGATOR
References: