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

NCT06721572 | Completed FDA Device

• 2 other identifiers: HUM00260188025780
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Abdominal Pain; Transcutaneous Electrical Acustimulation; Acupuncture; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Difference of the difference of the Pain Severity Score based the Brief Pain Inventory-Short Form (BPI-SF) between start and end of each treatment period

  The 4 pain intensity items (worst, least, average, and current pain) are rated on an 11-point numerical rating scale (0 = no pain, 10 = worst possible pain). A Pain Severity Score is calculated by adding the scores for the 4 items pertaining to pain intensity and then dividing this by 4. A higher number indicates higher levels of pain.

  Baseline-4 weeks and weeks 6-10

Secondary Outcomes (5)

• Difference of the difference of the Pain Interference Score on BPI-SF between start and end of each treatment period

  Baseline-4 weeks and weeks 6-10

• Difference of the difference of the average worst daily abdominal pain using a numeric rating scale (0-10) between start and end of each treatment period (baseline-4 weeks and weeks 6-10)

  Baseline-4 weeks and weeks 6-10

• Difference of the difference of the Change of Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) score between start and end of each treatment period

  Baseline-4 weeks and weeks 6-10

• Patient Global Impression of Change (PGIC) at end of each treatment period between the intervention group and sham group

  4 weeks and 10 week

• Predict difference of the difference of Pain Severity Score using pain widespreadedness at beginning of each treatment period

  Baseline-4 weeks and weeks 6-10

Study Arms (2)

Active TEA first followed by sham TEA

EXPERIMENTAL

Subjects will undergo active TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then sham TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA.

Device: TEA

Sham TEA first followed by active TEA

EXPERIMENTAL

Subjects will undergo sham TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then active TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA.

Device: TEA

Interventions

TEA DEVICE

Active TEA or sham TEA will be self-administered at home over two daily treatment sessions of 30 minutes each in the morning and evening. Active TEA will be delivered through an active stimulation acupoint that has previously shown to reduce abdominal pain in other patient populations. Sham TEA will be administered at a different point a few cm away from the active site and that has been shown to be ineffective in reducing pain. Other than the location, the anatomical location, application of TEA and sham will be identical. The device will be programmed by the study team to generate fixed frequency, pulse width, and time on/time off during the pulsed stimulation. The subject is only able to change the stimulation output in a range from 0-10 milliampere.

Active TEA first followed by sham TEA; Sham TEA first followed by active TEA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis; Abdominal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Jorge D Machicado, MD, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will receive sham or active TEA with an identical device and set of electrodes. Outcomes will be assessed via self-reported surveys. The study coordinator will be unblinded to the randomized treatment assignment. The study coordinator will implement the randomization, conduct the active and sham TEA instruction sessions, and answer study-related questions to patients. The study coordinator will not be involved in the data analysis and will not reveal treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: Subjects will be randomly assigned in a 1:1 allocation ratio to one of two treatment sequences: i) active-TEA in treatment period 1 (week 1-4), followed by sham-TEA in treatment period 2 (week 7-10), or ii) sham-TEA in treatment period 1 (week 1-4), followed by active-TEA in treatment period 2 (week 7-10).

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: January 13, 2025
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)