Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Subjects Wit… (NCT06721572) | Clinical Trial Compass
CompletedNot Applicable
Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Subjects With Chronic Pancreatitis
United States42 participantsStarted 2025-01-13
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wi…
What they're measuring
1
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