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

Description

Transcutaneous Electrical Acustimulation (TEA) is a noninvasive acupuncture method that can be self-administered at home without needles. TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. This study will help elucidate if TEA is effective in treating abdominal pain in patients with painful chronic pancreatitis (CP).

Conditions

Chronic Pancreatitis, Pancreatitis

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Study Overview

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Study Details

Study overview

Transcutaneous Electrical Acustimulation (TEA) is a noninvasive acupuncture method that can be self-administered at home without needles. TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. This study will help elucidate if TEA is effective in treating abdominal pain in patients with painful chronic pancreatitis (CP).

Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis (TEA-CuP): A Double-Blind, Sham-Controlled Crossover Trial

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

Condition
Chronic Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Jorge D Machicado, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2027-12