Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Subjects With Chronic Pancreatitis

Launched by UNIVERSITY OF MICHIGAN · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment method called Transcutaneous Electrical Acustimulation (TEA) for patients suffering from chronic pancreatitis, a condition that causes ongoing abdominal pain. TEA is a needle-free approach that uses small electrical currents to stimulate specific points on the body, similar to acupuncture. The goal of this study is to see if TEA can help reduce pain for those with chronic pancreatitis, helping them manage their symptoms from the comfort of their own homes.

To participate in the trial, individuals need to have a diagnosis of chronic pancreatitis and have been experiencing moderate abdominal pain for at least three months. The trial is open to adults aged 65 to 74 years, regardless of gender. Participants will be guided on how to use the TEA device at home, and they will complete questionnaires about their pain levels and overall wellbeing. It’s important to note that certain individuals, such as those who are pregnant or breastfeeding, or those with specific medical conditions, may not be eligible to join the study. This trial aims to provide valuable insights into a potentially effective pain relief option for chronic pancreatitis patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of definite or suspected Chronic Pancreatitis (CP). Definite CP features include presence of pancreatic calcifications or Cambridge grade 3-4 on imaging. Suspected CP features include presence of Rosemont criteria suggestive of CP on endoscopic ultrasound or 2 documented attacks of acute pancreatitis separated by at least 1 month without other definite or suspected CP features.
• • Abdominal pain that is present for at least 3 months prior to enrollment and having experienced moderate intensity abdominal pain (rated as 4 or higher on a 0-10 Numeric Rating Scale) at least once in the last month.
• Exclusion Criteria:
• • Breastfeeding mother
• • Pregnant or intending to become pregnant within the next 3 months
• • Incarcerated individuals
• • Unwillingness or inability to consent
• • Unable to read and speak English precluding completion of questionnaires.
• • Familiarity with acupoints that limit blinding
• • Currently receiving acupuncture therapy
• • Participation in another clinical trial
• • Undergoing treatment for cancer or has a suspected or confirmed diagnosis of pancreatic cancer
• • Substantial cognitive impairment or mental illness that would prevent providing informed consent and completion of questionnaires.
• • Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
• • History of total pancreatectomy with or without islet autotransplantation
• • Had during the past month or plan to have within the next 3 months at least one of the following procedures: endoscopic retrograde cholangiopancreatography, pancreatic pseudocyst drainage, celiac plexus block or neurolysis, extracorporeal shock wave lithotripsy, or surgical pancreatic resection or drainage procedure
• • Presence of obstructed pancreatic duct that has not yet undergone an attempt for ductal decompression.
• • Known allergy to adhesive Electrocardiogram (ECG) electrodes
• • History of vagal nerve surgery
• • History of bilateral below the knee amputation
• • History of lower extremity paralysis
• • Presence of an implantable electrical stimulation device