Spinal Cord Stimulation for the Treatment of Pain in Chronic Pancreatitis

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06230120
• Other study ID #: N-20200077
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Gastroenterology, Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantitative sensory testing: Pressure algometry	Pain detection and tolerance thresholds (kPa)	At baseline an immediately after the intervention
Other	Quantitative sensory testing: Repetitive pinprick stimulation	Difference in pain scores (VAS) between 1st and 10th stimulus	At baseline an immediately after the intervention
Other	Quantitative sensory testing: Cold pressor test	Cold pressor endurance time (seconds)	At baseline an immediately after the intervention
Other	Quantitative sensory testing: Conditioned pain modulation	Relative change in pressure tolerance threshold before and after cold pressor test (%)	At baseline an immediately after the intervention
Primary	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	Patient Global Impression of Change (PGIC)	The Patient Global Impression of Change assessed after each stimulation period	Immediately after the intervention
Secondary	The modified Brief Pain Inventory short-form (mBPI-sf)	Differences in the pain and functioning composite scores of the modified Brief Pain Inventory short-form between stimulation period (SCS vs sham)	At baseline an immediately after the intervention
Secondary	Comprehensive Pain Assessment Tool short-form (COMPAT-sf)	Differences in the Comprehensive Pain Assessment Tool short-form (COMPAT-sf) total score and subscroes between stimulation periods (SCS vs sham)	At baseline an immediately after the intervention
Secondary	Quality of life using SF 36 (short form 36 health survey)	Differences in the SF 36 (short form 36 health survey) total score and subscores between stimulation periods (SCS vs sham)	At baseline an immediately after the intervention
Secondary	Symptoms of depression and anxiety as documented by the Hospital Anxiety and Depression Scale (HADS)	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)	At baseline an immediately after the intervention