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

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015945
• Other study ID #: HUM00225786
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: April 2025

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Colin Burnett
• Phone: 734-647-2806
• Email: bucolin[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Device:
• Transcutaneous Electrical Acustimulation (TEA)
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of approached participants that meet eligibility criteria		Approximately 1 year (during the recruitment period)
Primary	Proportion of approached and eligible participants that provide informed consent		Approximately 1 year (during the recruitment period)
Primary	Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent.		Approximately 2 weeks
Primary	Proportion of participants that start the intervention among those that meet run-in period criteria.		Baseline visit (V1)
Primary	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)
Primary	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
Primary	Median interquartile range (IQR) of the time that it takes to complete visit number one		Baseline visit (V1)
Primary	Median interquartile range (IQR) of the time that it takes to complete visit number two		4 weeks (after treatment period)
Primary	Proportion of participants that come for visit 1 and complete all the surveys involved in the study		Approximately 2 weeks
Primary	Proportion of study surveys that are completed per protocol		Baseline visit (V1) to 8 weeks (V3)