Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis

University of Michigan

Status: Completed

Conditions: Chronic Pancreatitis

Treatments: Device: Transcutaneous Electrical Acustimulation (TEA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06015945

HUM00225786

Details and patient eligibility

About

This research is studying a new noninvasive device-based therapy called Transcutaneous Electrical Acustimulation (TEA) to learn about its safety and how well it works as a treatment of pain in chronic pancreatitis. The purpose of this study is to investigate the potential of TEA to treat abdominal pain in patients with chronic pancreatitis (CP).

The study hypothesizes that TEA can be used as a non-pharmaceutical opioid-free approach to treat pain in chronic pancreatitis.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic pancreatitis (CP), based on a score greater or equal to 4 using a previously validated Mayo scoring system that uses morphologic and functional criteria, or endosonographic features suggestive or consistent with CP based on Rosemont criteria.
• Abdominal pain present at least once within the last month
• Willing and able to provide written informed consent

Exclusion criteria

• Pregnancy or breastfeeding mother
• Imprisoned individuals
• Non-English speaking patients
• Scheduled for or with a history of pancreatic surgery (e.g. Total Pancreatectomy with Islet Auto Transplantation (TPIAT), Puestow, Frey, Whipple, other)
• Currently undergoing or about to start endoscopic therapy with Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopic ultrasound (EUS)
• Recent history of acute pancreatitis as defined by the Revised Atlanta Classification within a month prior to enrollment
• Radiologic and clinical findings consistent with symptomatic pseudocyst, wall-off necrosis, infected pancreatic necrosis, or biliary obstruction within the last 6 months
• Self-reported daily use of opioids for > 12 months for weak opioids (codeine, tramadol and hydrocodone) or > 6 months for strong opioids (other opioids) in the last two years.

-Self-reported ongoing illicit drug use or abuse-

• Suspected or diagnosed pancreatic cancer
• Receiving chemotherapy for cancer
• Known allergy to adhesive electrocardiogram (ECG) electrodes
• Patients with bilateral below the knee amputation
• Patients with lower extremity paralysis
• Patient is participating in another clinical trial
• Patients with an implantable electrical stimulation device.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Transcutaneous Electrical Acustimulation (TEA)

Experimental group

Treatment:

Device: Transcutaneous Electrical Acustimulation (TEA)