Chronic Pancreatitis
Conditions
Keywords
Abdominal pain, Transcutaneous Acustimulation
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.
Interventions
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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Approached Individuals Who Met Eligibility Criteria | Approximately 1 year (during the recruitment period) | 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. |
| Proportion of Approached and Eligible Participants Who Provided Informed Consent | Approximately 1 year (during the recruitment period) | 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. |
| Proportion of Participants Who Met the Eligibility Criteria After the run-in Period for the Participants Who Provided Informed Consent. | Approximately 2 weeks | 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. |
| Proportion of Participants Who Started the Intervention Among Those Who Met run-in Period Criteria. | Baseline visit (V1) | Results reflect the participants who completed the run-in period and received the first TEA treatment. |
| Proportion of Participants That Adhere to the Intervention as Prescribed Among Participants That Start the Intervention | Weeks 1-4 (after the 4-week treatment period) | 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 Who Completed Follow up Visit at 4 Weeks and Return Complete Follow-up Questionnaires at Week 8, Among Participants Who Started the Intervention | Week 8 | Results reflect participants who started the TEA and who returned the follow-up questionnaires at week 4 and week 8 (end of the study). |
| Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number One | Baseline visit (V1) | Results reflect the time taken to complete visit 1 in minutes. Data was collected using time-stamp data from the Redcap system. |
| Median Interquartile Range (IQR) of the Time That it Takes to Complete Visit Number Two | 4 weeks (after treatment period) | Results reflect the time taken to complete visit 2 in minutes. Data was collected using time-stamp data from the Redcap system. |
| Proportion of Participants Who Came for Visit 1 and Completed All the Surveys Involved in the Study | Approximately 2 weeks | Results reflect the participants who came for visit 1 and completed all the surveys involved in the study. |
| Percentage of Study Surveys That Were Completed Per Protocol | 8 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJorge Machicado, MD
University of Michigan
Participant flow
Pre-assignment details
Two consented, potentially eligible individuals did not complete the run-in period and, therefore, were determined to not be eligible to become participants.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 11.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
None listed