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Behavioural Intervention

Electrical Acustimulation for Chronic Pancreatitis (TEA-CuP Trial)

N/A

Waitlist Available

Led By Jorge D Machicado, MD, MPH

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 definite or suspected Chronic Pancreatitis (CP) with specific imaging or clinical criteria

Abdominal pain present for at least 3 months and experiencing moderate intensity abdominal pain (rated as 4 or higher on a 0-10 Numeric Rating Scale) at least once in the last month

Must not have

History of lower extremity paralysis

History of vagal nerve surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline-4 weeks and weeks 6-10

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a noninvasive acupuncture method called Transcutaneous Electrical Acustimulation (TEA) can help reduce abdominal pain in patients with painful chronic pancreatitis. It involves using a

Who is the study for?

This trial is for individuals with chronic pancreatitis who've had moderate to severe abdominal pain for at least 3 months. They must not be pregnant, breastfeeding, or planning pregnancy soon; have no history of certain surgeries or paralysis; and not be participating in other trials.

What is being tested?

The study tests Transcutaneous Electrical Acustimulation (TEA), a home-based treatment that applies electrical currents to acupoints to reduce abdominal pain in patients with chronic pancreatitis.

What are the potential side effects?

Since TEA is noninvasive and uses weak electrical currents, side effects are minimal but may include skin irritation at the electrode sites or discomfort from the electrical 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.

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I have had moderate abdominal pain for at least 3 months.

Exclusion Criteria

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

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I have had paralysis in my legs.

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I have had surgery on my vagal nerve.

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

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I am currently undergoing acupuncture treatment.

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I have had my entire pancreas removed, with or without islet cell transplant.

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I am being treated for cancer or have been diagnosed with pancreatic cancer.

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I am able to understand and provide consent for my treatment.

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My pancreatic duct is blocked and hasn't been treated to relieve the blockage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline-4 weeks and weeks 6-10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline-4 weeks and weeks 6-10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline-4 weeks and weeks 6-10 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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

Secondary study objectives

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

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

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)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham TEA first followed by active TEAExperimental Treatment1 Intervention

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.

Group II: Active TEA first followed by sham TEAExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TEA

2017

Completed Phase 3

~370

0 / 10Eligibility criteria met