Shock therapy for belly pain? home device shows promise for pancreatitis
NCT ID NCT06721572
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study tested a small, needle-free device that sends mild electrical pulses to specific points on the skin to relieve abdominal pain in people with chronic pancreatitis. 42 adults with long-term pancreas pain used the device at home for several weeks. The goal was to see if this simple, non-invasive approach could safely reduce pain compared to a fake (sham) device.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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42 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * History of vagal nerve surgery * History of bilateral below the knee amputation * History of lower extremity paralysis * Presence of an implantable electrical stimulation device
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Michigan
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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