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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The severity and frequency participants pain will be measured during a run-in period of 2 weeks 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.
University of Michigan
Ann Arbor, Michigan, United States
Proportion of Approached Individuals Who Met Eligibility Criteria
This feasibility outcome measured eligibility of individuals to participate, as opposed to any effects of the intervention. Results reflect the total number of individuals who were approached as the number analyzed, and of that population, the number who were eligible to be consented and proceed to the run-in period.
Time frame: Approximately 1 year (during the recruitment period)
Proportion of Approached and Eligible Participants Who Provided Informed Consent
This outcome measured feasibility and willingness of individuals to participate, as opposed to any effects of the intervention. Therefore, the "participants" analyzed below include all of the individuals determined to be eligible as shown in Outcome Measure 1.
Time frame: Approximately 1 year (during the recruitment period)
Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent.
This outcome measured feasibility and continued eligibility of individuals to allow them to begin to participate in the actual trial, as opposed to any effects of the intervention. Therefore, the "participants" analyzed below include all of the individuals who were determined to be eligible and who were consented, as shown in Outcome Measure 2. These "participants" began a 2-week run-in period to confirm baseline pain and trial eligibility. Results reflect participants who were determined to still be eligible after the run-in period.
Time frame: Approximately 2 weeks
Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria.
Results reflect the participants who completed the run-in period and received the first TEA treatment.
Time frame: 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.
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Time frame: Weeks 1-4 (after the 4-week treatment period)
Proportion of Participants Who Completed Follow up Visit at 4 Weeks and Return Complete Follow-up Questionnaires at Week 8, Among Participants Who Started the Intervention
Results reflect participants who started the TEA and who returned the follow-up questionnaires at week 4 and week 8 (end of the study).
Time frame: Week 8
Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One
Results reflect the time taken to complete visit 1 in minutes. Data was collected using time-stamp data from the Redcap system.
Time frame: Baseline visit (V1)
Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two
Results reflect the time taken to complete visit 2 in minutes. Data was collected using time-stamp data from the Redcap system.
Time frame: 4 weeks (after treatment period)
Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study
Results reflect the participants who came for visit 1 and completed all the surveys involved in the study.
Time frame: Approximately 2 weeks
Percentage of Study Surveys That Were Completed Per Protocol
Results reflect the percentage of surveys that participants completed during the treatment period (between visit 1 and visit 2) and the follow-up period (between visit 2 and visit 3). Each participant was sent 80 surveys total between visits 1 and 3, with 40 being sent between visit 1 and visit 2, and 40 being sent between visit 2 and visit 3. The time between visit 1 and visit 2 was 4 weeks, and the time between visit 2 and visit 3 was 4 weeks.
Time frame: 8 weeks