Electrical Acustimulation for Chronic Pancreatitis

(TEA-CuP Trial)

Overseen By Merrick Bay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Cancer, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous Electrical Acustimulation for Chronic Pancreatitis?

Research shows that transcutaneous electrical nerve stimulation (TENS), a component of the treatment, provided prompt and sustained pain relief in patients with pancreatitis, suggesting potential benefits for managing chronic pancreatitis pain. ^{1 2 3 4 5}

Is electrical acustimulation safe for humans?

Transcutaneous electrical acustimulation (TEA) and similar treatments like transcutaneous electrical nerve stimulation (TENS) are generally considered safe and noninvasive, as they have been used in studies for pain relief in conditions like pancreatitis without significant safety concerns. ^{1 2 3 4 6}

How does the treatment Transcutaneous Electrical Acustimulation differ from other treatments for chronic pancreatitis?

Transcutaneous Electrical Acustimulation (TEA) is unique because it uses electrical stimulation applied through the skin to potentially relieve pain and improve gastrointestinal function, unlike traditional treatments that often rely on medications or invasive procedures. This non-invasive approach may offer an alternative for managing symptoms without the side effects associated with drugs. ^{1 2 3 4 6}

What is the purpose of this trial?

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).

Research Team

Jorge Machicado, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

I have been diagnosed with chronic pancreatitis.

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

Exclusion Criteria

Breastfeeding mother

Participation in another clinical trial

Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study

Timeline

Run-in

Participants undergo a run-in period to establish baseline measurements

1 week

1 visit (virtual)

Treatment Period 1

Participants receive either active TEA or sham TEA for 4 weeks

4 weeks

1 visit (in-person or virtual)

Washout

Participants undergo a washout period to eliminate effects of the first treatment

2 weeks

Treatment Period 2

Participants receive the alternate treatment (sham TEA or active TEA) for 4 weeks

4 weeks

1 visit (in-person or virtual)

Close-out

Final assessments and data collection are conducted

1 week

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous Electrical Acustimulation

Trial Overview 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.

Participant Groups

Group I: Sham TEA first followed by active TEA Experimental Treatment 1 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 TEA Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

American College of Gastroenterology

Collaborator

Trials

40

Recruited

6,900+

Findings from Research

Transcutaneous electrical acustimulation (TEA) significantly reduced abdominal pain and bloating in 42 patients with acute pancreatitis compared to a sham treatment, indicating its efficacy in managing symptoms.

TEA improved gastrointestinal motility by increasing normal gastric slow waves and reducing inflammatory markers like TNF-α, suggesting that its benefits may be linked to changes in autonomic function and ghrelin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative effects of transcutaneous electrical acustimulation on abdominal pain, gastrointestinal motility, and inflammation in patients with early-stage acute pancreatitis. Xuan, JL., Zhu, YW., Xu, WH., et al.[2022]

In a study involving 23 patients with chronic pancreatitis, neither electroacupuncture nor transcutaneous electric nerve stimulation (TENS) provided significant pain relief compared to sham treatments.

The findings suggest that these alternative therapies do not effectively replace or enhance standard medical treatments for managing pain in pancreatitis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture and transcutaneous electric nerve stimulation in the treatment of pain associated with chronic pancreatitis. A randomized study. Ballegaard, S., Christophersen, SJ., Dawids, SG., et al.[2019]

Transcutaneous electrical nerve stimulation (TENS) provided quick and lasting pain relief for patients suffering from pancreatitis, including both acute and recurrent cases, as observed in six patients overall.

Given its noninvasive nature and effectiveness in reducing the need for stronger pain medications, further clinical trials are recommended to explore TENS as a treatment option for pancreatitis pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the management of pancreatitis pain. Roberts, HJ.[2019]

Direct electrical stimulation of the celiac plexus effectively relieved intractable abdominal pain in a patient with chronic pancreatitis, suggesting a promising treatment option for similar cases.

This technique is simple and safe, potentially benefiting not only chronic pancreatitis patients but also those with pancreatic cancer and other upper abdominal pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the celiac plexus for pain relief in chronic pancreatitis. A clinical note. Srikantha, K., Choi, JJ., Wu, WH.[2019]

In a study involving 89 patients with acute pancreatitis, electroacupuncture (EA) did not significantly reduce pain levels compared to conventional treatment after 4 days, as measured by the visual analogue scale (VAS).

However, patients receiving EA were able to resume food intake significantly faster than those in the control group, indicating a potential benefit of EA in improving recovery time despite similar pain relief outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: A three-arm randomized controlled trial. Kee Jang, D., Kyu Lee, J., Yung Jung, C., et al.[2023]

Electroacupuncture (EA) significantly reduced pancreatic weight and improved pancreatic health in rats with acute pancreatitis induced by cholecystokinin (CCK), suggesting its potential as a therapeutic intervention.

EA treatment increased levels of protective proteins (HSP60 and HSP72) and enhanced the release of ACTH in the blood, indicating a possible mechanism for its protective effects against pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electroacupuncture protects against CCK-induced acute pancreatitis in rats. An, HJ., Lee, JH., Lee, HJ., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Integrative effects of transcutaneous electrical acustimulation on abdominal pain, gastrointestinal motility, and inflammation in patients with early-stage acute pancreatitis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Acupuncture and transcutaneous electric nerve stimulation in the treatment of pain associated with chronic pancreatitis. A randomized study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the management of pancreatitis pain. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the celiac plexus for pain relief in chronic pancreatitis. A clinical note. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: A three-arm randomized controlled trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Electroacupuncture protects against CCK-induced acute pancreatitis in rats. [2013]