What side effects are associated with this type of intervention?

Common treatments for chronic pancreatitis include pain management strategies such as medications, lifestyle changes, and noninvasive therapies like Transcutaneous Electrical Nerve Stimulation (TENS) and Transcutaneous Electrical Acustimulation (TEA). The side effects of noninvasive electrical stimulation therapies are generally mild and may include skin irritation, discomfort at the site of electrode placement, and muscle twitching. These treatments are considered safe and are often used as an opioid-free approach to manage chronic pain.

What prior FDA approvals exist?

Currently, there are no specific FDA approvals for Transcutaneous Electrical Acustimulation (TEA) for the treatment of chronic pancreatitis. However, similar noninvasive electrical stimulation methods, such as Transcutaneous Electrical Nerve Stimulation (TENS), have been used for pain management in various chronic conditions. TENS is FDA-approved and works by modulating pain pathways through electrical impulses. While TEA is being studied for its potential in treating abdominal pain in chronic pancreatitis, it represents an innovative approach that builds on the principles of TENS therapy.

What other types of research exist?

Promising alternatives to TEA for Chronic Pancreatitis pain management include Spinal Cord Stimulation (SCS) and Transcutaneous Electrical Nerve Stimulation (TENS). Both methods are noninvasive and have shown efficacy in modulating pain pathways. SCS involves the implantation of a device that sends electrical pulses to the spinal cord, while TENS uses surface electrodes to deliver electrical stimulation to nerves.

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Behavioural Intervention

TEA for Chronic Pancreatitis

N/A

Waitlist Available

Led By Jorge Machicado, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Receiving chemotherapy for cancer

Non-English speaking patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1-4 (after the 4-week treatment period)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called Transcutaneous Electrical Acustimulation (TEA) for people with chronic pancreatitis. TEA uses a device to send small electrical currents through the skin to help reduce pain. The goal is to find a safe, non-drug alternative to manage pain without using opioids. Transcutaneous electrical acupoint stimulation (TEAS) has been used in various studies for pain management and addiction treatment, showing potential benefits in reducing pain and aiding recovery.

Who is the study for?

This trial is for adults with chronic pancreatitis who've had abdominal pain at least once in the last month. They must understand English and consent to participate. It's not for pregnant or breastfeeding women, those with a history of pancreatic surgery, recent acute pancreatitis, certain pancreatic complications, long-term opioid use, cancer treatments, other trials participation, electrical device implants, drug abuse issues or specific allergies.

What is being tested?

The study tests Transcutaneous Electrical Acustimulation (TEA), a non-drug method that might help manage pain without opioids in people with chronic pancreatitis. Participants will use this new therapy to see if it reduces their abdominal pain effectively and safely.

What are the potential side effects?

Since TEA is noninvasive and doesn't involve drugs, side effects may be minimal but could include skin irritation from the adhesive electrodes or discomfort at the site of stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic pancreatitis according to Mayo or Rosemont criteria.

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I have experienced abdominal pain at least once in the past month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing chemotherapy for cancer.

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I do not speak English.

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I have had a recent episode of severe pancreatitis.

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I am currently undergoing or about to start endoscopic therapy.

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I have been using opioids daily for more than 12 months if weak, or more than 6 months if strong, in the last two years.

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I have paralysis in my lower limbs.

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I have had or am scheduled for surgery on my pancreas.

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I have or might have pancreatic cancer.

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I have had both of my legs amputated below the knees.

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I've had issues like a pseudocyst or biliary obstruction in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1-4 (after the 4-week treatment period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1-4 (after the 4-week treatment period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1-4 (after the 4-week treatment period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants that adhere to the intervention as prescribed among participants that start the intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous Electrical Acustimulation (TEA)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Electrical Acustimulation (TEA)

2021

N/A

~30

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Pancreatitis aim to manage pain, which is a significant symptom affecting patients' quality of life. Transcutaneous Electrical Acustimulation (TEA) and similar noninvasive electrical stimulation therapies work by modulating pain pathways. These treatments deliver electrical impulses to specific nerve sites, which can alter pain signal transmission and reduce pain perception. This mechanism is crucial for Chronic Pancreatitis patients as it offers a non-pharmaceutical, opioid-free approach to pain management, potentially reducing the risk of medication-related side effects and improving overall treatment outcomes.