Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis

Study Overview
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Brief Summary
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This research is studying a new noninvasive device-based therapy called Transcutaneous Electrical Acustimulation (TEA) to learn about its safety and how well it works as a treatment of pain in chronic pancreatitis. The purpose of this study is to investigate the potential of TEA to treat abdominal pain in patients with chronic pancreatitis (CP). The study hypothesizes that TEA can be used as a non-pharmaceutical opioid-free approach to treat pain in chronic pancreatitis.

Official Title
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Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis- A Pilot Study

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Device: Transcutaneous Electrical Acustimulation (TEA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic pancreatitis (CP), based on a score greater or equal to 4 using a previously validated Mayo scoring system that uses morphologic and functional criteria, or endosonographic features suggestive or consistent with CP based on Rosemont criteria. Abdominal pain present at least once within the last month Willing and able to provide written informed consent Exclusion Criteria: Pregnancy or breastfeeding mother Imprisoned individuals Non-English speaking patients Scheduled for or with a history of pancreatic surgery (e.g. Total Pancreatectomy with Islet Auto Transplantation (TPIAT), Puestow, Frey, Whipple, other) Currently undergoing or about to start endoscopic therapy with Endoscopic retrograde cholangiopancreatography (ERCP) or Endoscopic ultrasound (EUS) Recent history of acute pancreatitis as defined by the Revised Atlanta Classification within a month prior to enrollment Radiologic and clinical findings consistent with symptomatic pseudocyst, wall-off necrosis, infected pancreatic necrosis, or biliary obstruction within the last 6 months Self-reported daily use of opioids for > 12 months for weak opioids (codeine, tramadol and hydrocodone) or > 6 months for strong opioids (other opioids) in the last two years. -Self-reported ongoing illicit drug use or abuse- Suspected or diagnosed pancreatic cancer Receiving chemotherapy for cancer Known allergy to adhesive electrocardiogram (ECG) electrodes Patients with bilateral below the knee amputation Patients with lower extremity paralysis Patient is participating in another clinical trial Patients with an implantable electrical stimulation device.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous Electrical Acustimulation (TEA)<br> | Device: Transcutaneous Electrical Acustimulation (TEA)<br>* The severity and frequency participants pain will be measured during a run-in period of 2 weeks with to assess baseline pain severity and frequency. Eligible participants will have a 4-week treatment period at home. Stimulation with the TEA device will be performed for 30 minutes twice per day, in the morning and in the evening. In addition to using the device, participants will have study visits, complete surveys, as well as provide medical information during the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of approached participants that meet eligibility criteria |  | Approximately 1 year (during the recruitment period) | 
| Proportion of approached and eligible participants that provide informed consent |  | Approximately 1 year (during the recruitment period) | 
| Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent. |  | Approximately 2 weeks | 
| Proportion of participants that start the intervention among those that meet run-in period criteria. |  | Baseline visit (V1) | 
| Proportion of participants that adhere to the intervention as prescribed among participants that start the intervention | Adherence will be directly monitored through use of the TEA device. The TEA automatically records duration of use, time of the day, and stimulation intensity. | Weeks 1-4 (after the 4-week treatment period) | 
| Proportion of participants that complete follow up visit at 4 weeks and return complete follow-up questionnaires at week 8, among participants that started the intervention |  | Week 8 | 
| Median interquartile range (IQR) of the time that it takes to complete visit number one |  | Baseline visit (V1) | 
| Median interquartile range (IQR) of the time that it takes to complete visit number two |  | 4 weeks (after treatment period) | 
| Proportion of participants that come for visit 1 and complete all the surveys involved in the study |  | Approximately 2 weeks | 
| Proportion of study surveys that are completed per protocol |  | Baseline visit (V1) to 8 weeks (V3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal pain, Transcutaneous Acustimulation