Clinical trial NCT06015945: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pancreatitis
Keywords: Abdominal pain
Transcutaneous Acustimulation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of approached participants that meet eligibility criteria
timeFrame: Approximately 1 year (during the recruitment period)
measure: Proportion of approached and eligible participants that provide informed consent
timeFrame: Approximately 1 year (during the recruitment period)
measure: Proportion of participants that meet the eligibility criteria after the run-in period for the participants that provided informed consent.
timeFrame: Approximately 2 weeks
measure: Proportion of participants that start the intervention among those that meet run-in period criteria.
timeFrame: Baseline visit (V1)
measure: Proportion of participants that adhere to the intervention as prescribed among participants that start the intervention
timeFrame: Weeks 1-4 (after the 4-week treatment period)
measure: 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
timeFrame: Week 8
measure: Median interquartile range (IQR) of the time that it takes to complete visit number one
timeFrame: Baseline visit (V1)
measure: Median interquartile range (IQR) of the time that it takes to complete visit number two
timeFrame: 4 weeks (after treatment period)
measure: Proportion of participants that come for visit 1 and complete all the surveys involved in the study
timeFrame: Approximately 2 weeks
measure: Proportion of study surveys that are completed per protocol
timeFrame: Baseline visit (V1) to 8 weeks (V3)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jorge Machicado, MD
role: PRINCIPAL_INVESTIGATOR
References: