Electrical Acustimulation for Chronic Pancreatitis
(TEA-CuP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new, noninvasive method to relieve abdominal pain in people with chronic pancreatitis, a long-lasting inflammation of the pancreas. The treatment, Transcutaneous Electrical Acustimulation (TEA), uses a mild electrical current through small electrodes placed on the skin. Participants will try both active TEA and a sham (placebo) version to determine if the real treatment reduces pain. The trial seeks individuals diagnosed with chronic pancreatitis who have experienced moderate abdominal pain for at least three months. As an unphased trial, this study offers a unique opportunity to explore innovative pain relief methods for chronic pancreatitis.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.
What prior data suggests that this method is safe for treating chronic pancreatitis?
A previous study demonstrated that Transcutaneous Electrical Acustimulation (TEA) safely reduces pain in various stomach and digestive conditions. This technique uses a gentle electrical current sent through pads placed on the skin at specific points. It is noninvasive and does not involve needles, making it easy to use at home.
Research has shown that TEA can help with stomach issues, such as reducing belly pain and aiding digestion. It also appears to lower inflammation in the body. These findings suggest that TEA is well-tolerated and may be a safe option for managing pain in chronic pancreatitis.12345Why are researchers excited about this trial?
Researchers are excited about Transcutaneous Electrical Acustimulation (TEA) for chronic pancreatitis because it offers a non-invasive alternative to traditional treatments like pain medications, enzyme supplements, and surgery. TEA uses electrical currents to stimulate acupuncture points, potentially providing pain relief without the side effects associated with drugs. This technique could address the root of pain by enhancing nerve function and improving pancreatic health, setting it apart from other options that primarily focus on symptom management. By offering a novel approach to treatment, TEA presents the possibility of a more holistic management strategy for chronic pancreatitis sufferers.
What evidence suggests that Transcutaneous Electrical Acustimulation is effective for chronic pancreatitis?
Research has shown that Transcutaneous Electrical Acustimulation (TEA) can help reduce belly pain in various digestive conditions. TEA sends a gentle electrical current through small pads placed on the skin at specific points. Early findings suggest that this method can ease belly pain, improve digestion, and reduce inflammation. Some studies have demonstrated that TEA can decrease pain and enhance gut function when used early in cases of sudden pancreatitis. In this trial, participants will receive either active TEA followed by sham TEA or sham TEA followed by active TEA to evaluate its effectiveness for long-term pancreatitis. While these results are promising, more research is needed to confirm its effectiveness for long-term pancreatitis.12356
Who Is on the Research Team?
Jorge Machicado, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Run-in
Participants undergo a run-in period to establish baseline measurements
Treatment Period 1
Participants receive either active TEA or sham TEA for 4 weeks
Washout
Participants undergo a washout period to eliminate effects of the first treatment
Treatment Period 2
Participants receive the alternate treatment (sham TEA or active TEA) for 4 weeks
Close-out
Final assessments and data collection are conducted
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Electrical Acustimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
American College of Gastroenterology
Collaborator