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

Primary Purpose

Chronic Pancreatitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Acustimulation (TEA)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Abdominal pain, Transcutaneous Acustimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcutaneous Electrical Acustimulation (TEA)

Arm Description

Outcomes

Primary Outcome Measures

Proportion of approached participants that meet eligibility criteria
Proportion of approached and eligible participants that provide informed consent
Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent.
Proportion of participants that start the intervention among those that meet run-in period criteria.
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.
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
Median interquartile range (IQR) of the time that it takes to complete visit number one
Median interquartile range (IQR) of the time that it takes to complete visit number two
Proportion of participants that come for visit 1 and complete all the surveys involved in the study
Proportion of study surveys that are completed per protocol

Secondary Outcome Measures

Full Information

First Posted
August 22, 2023
Last Updated
August 23, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT06015945
Brief Title
Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis
Official Title
Role of Home-based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis- A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
Abdominal pain, Transcutaneous Acustimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Electrical Acustimulation (TEA)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Acustimulation (TEA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of approached participants that meet eligibility criteria
Time Frame
Approximately 1 year (during the recruitment period)
Title
Proportion of approached and eligible participants that provide informed consent
Time Frame
Approximately 1 year (during the recruitment period)
Title
Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent.
Time Frame
Approximately 2 weeks
Title
Proportion of participants that start the intervention among those that meet run-in period criteria.
Time Frame
Baseline visit (V1)
Title
Proportion of participants that adhere to the intervention as prescribed among participants that start the intervention
Description
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.
Time Frame
Weeks 1-4 (after the 4-week treatment period)
Title
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
Time Frame
Week 8
Title
Median interquartile range (IQR) of the time that it takes to complete visit number one
Time Frame
Baseline visit (V1)
Title
Median interquartile range (IQR) of the time that it takes to complete visit number two
Time Frame
4 weeks (after treatment period)
Title
Proportion of participants that come for visit 1 and complete all the surveys involved in the study
Time Frame
Approximately 2 weeks
Title
Proportion of study surveys that are completed per protocol
Time Frame
Baseline visit (V1) to 8 weeks (V3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colin Burnett
Phone
734-647-2806
Email
bucolin@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Machicado, MD
Phone
734-647-9252
Email
machicad@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Machicado, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Burnett
Phone
734-647-2806
Email
bucolin@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Jorge Machicado, MD
Phone
734-647-9252
Email
machicad@umich.edu
First Name & Middle Initial & Last Name & Degree
Jorge Machicado, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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