RECRUITING

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

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Conditions

Chronic PancreatitisPancreatitisAbdominal PainTranscutaneous Electrical AcustimulationAcupunctureChronic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2025-01-13
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06721572

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  1. * Breastfeeding mother
  2. * Pregnant or intending to become pregnant within the next 3 months
  3. * Incarcerated individuals
  4. * Unwillingness or inability to consent
  5. * Unable to read and speak English precluding completion of questionnaires.
  6. * Familiarity with acupoints that limit blinding
  7. * Currently receiving acupuncture therapy
  8. * Participation in another clinical trial
  9. * Undergoing treatment for cancer or has a suspected or confirmed diagnosis of pancreatic cancer
  10. * Substantial cognitive impairment or mental illness that would prevent providing informed consent and completion of questionnaires.
  11. * Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
  12. * History of total pancreatectomy with or without islet autotransplantation
  13. * 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
  14. * Presence of obstructed pancreatic duct that has not yet undergone an attempt for ductal decompression.
  15. * Known allergy to adhesive Electrocardiogram (ECG) electrodes
  16. * History of vagal nerve surgery
  17. * History of bilateral below the knee amputation
  18. * History of lower extremity paralysis
  19. * Presence of an implantable electrical stimulation device

Contacts and Locations

Study Contact

Benson Hang
CONTACT
734-764-5753
behang@umich.edu
Merrick Bay
CONTACT
734-936-4979
merricb@umich.edu

Principal Investigator

Jorge D Machicado, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-01-13
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Abdominal Pain
  • Transcutaneous Electrical Acustimulation
  • Acupuncture
  • Chronic Pain

Additional Relevant MeSH Terms

  • Chronic Pancreatitis
  • Pancreatitis