Chronic PancreatitisTEA-CuPNCT06721572
Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Subjects With Chronic Pancreatitis
A study testing TEA in people with Chronic Pancreatitis and Pancreatitis, run by University of Michigan at 1 site in United States.
Trial summary
Transcutaneous Electrical Acustimulation (TEA) is a noninvasive acupuncture method that can be self-administered at home without needles. TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis, Pancreatitis
- What is being tested?
- TEA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 16 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of definite or suspected Chronic Pancreatitis (CP). Definite CP features include presence of pancreatic calcifications or Cambridge grade 3-4 on imaging. Suspected CP features include presence of Rosemont criteria suggestive of CP on endoscopic ultrasound or 2 documented attacks of acute pancreatitis separated by at least 1 month without other definite or suspected CP features.
- Abdominal pain that is present for at least 3 months prior to enrollment and having experienced moderate intensity abdominal pain (rated as 4 or higher on a 0-10 Numeric Rating Scale) at least once in the last month.
Who cannot join
- Breastfeeding mother
- Pregnant or intending to become pregnant within the next 3 months
- Incarcerated individuals
- Unwillingness or inability to consent
- Unable to read and speak English precluding completion of questionnaires.
- Familiarity with acupoints that limit blinding
Show all 19Show fewer
- Currently receiving acupuncture therapy
- Participation in another clinical trial
- Undergoing treatment for cancer or has a suspected or confirmed diagnosis of pancreatic cancer
- Substantial cognitive impairment or mental illness that would prevent providing informed consent and completion of questionnaires.
- Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- History of total pancreatectomy with or without islet autotransplantation
- Had during the past month or plan to have within the next 3 months at least one of the following procedures: endoscopic retrograde cholangiopancreatography, pancreatic pseudocyst drainage, celiac plexus block or neurolysis, extracorporeal shock wave lithotripsy, or surgical pancreatic resection or drainage procedure
- Presence of obstructed pancreatic duct that has not yet undergone an attempt for ductal decompression.
- Known allergy to adhesive Electrocardiogram (ECG) electrodes
- History of vagal nerve surgery
- History of bilateral below the knee amputation
- History of lower extremity paralysis
- Presence of an implantable electrical stimulation device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis (TEA-CuP): A Double-Blind, Sham-Controlled Crossover Trial
Transcutaneous Electrical Acustimulation (TEA) is a noninvasive acupuncture method that can be self-administered at home without needles. TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. This study will help elucidate if TEA is effective in treating abdominal pain in patients with painful chronic pancreatitis (CP).
Read the detailed description
Pain in patients with CP is debilitating and impairs quality of life. Despite using medical, endoscopic, or surgical treatments, many patients continue experiencing substantial pain and some are prescribed long-term opioids. This clinical trial aims to assess the analgesic effect of a mild electrical stimulator called TEA. TEA consists of a small, wearable device that can be used at-home while doing daily activities. If effective, this could be an alternative non-pharmacological and non-invasive option to manage pain related to CP.
In this study, the investigators will conduct a randomized, sham-controlled, 2x2 crossover trial in patients with painful CP. Subjects will be randomized to receive either active TEA first followed by sham TEA, or sham TEA first followed by active TEA. Other than the application point in the skin, active and sham TEA will be identical. The study will examine the effect of TEA on pain severity (primary outcome), pain interference and overall pain experience (secondary outcomes). The study will be conducted over 12 weeks in 5 periods: run-in (1 week), treatment period 1 (4 weeks), washout (2 weeks), treatment period 2 (4 weeks), and close-out visit (1 week). Subjects will complete online questionnaires about pain and health throughout the duration of the study. There will be a total of 3 study visits that will be conducted at the main Ann Arbor Hospital or virtually. All the study tasks can be completed remotely. The study will recruit patients from a single clinical center and from self-referral from patients with CP in the US. The proposed study will advance our understanding on the role of TEA for non-opioid pain management of CP.
- Conditions
- Chronic Pancreatitis, Pancreatitis
- Being tested
- TEA
- Keywords
- Abdominal Pain, Transcutaneous Electrical Acustimulation, Acupuncture, Chronic Pain
- Medical subject headings
- Pancreatitis, Chronic, Pancreatitis, Abdominal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEADevice
Active TEA or sham TEA will be self-administered at home over two daily treatment sessions of 30 minutes each in the morning and evening. Active TEA will be delivered through an active stimulation acupoint that has previously shown to reduce abdominal pain in other patient populations. Sham TEA will be administered at a different point a few cm away from the active site and that has been shown to be ineffective in reducing pain. Other than the location, the anatomical location, application of TEA and sham will be identical. The device will be programmed by the study team to generate fixed frequency, pulse width, and time on/time off during the pulsed stimulation. The subject is only able to change the stimulation output in a range from 0-10 milliampere.
| Study group | Role | What they receive |
|---|---|---|
| Active TEA first followed by sham TEA | Experimental | Subjects will undergo active TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then sham TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA. Receives: Device: TEA |
| Sham TEA first followed by active TEA | Experimental | Subjects will undergo sham TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then active TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA. Receives: Device: TEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the difference of the Pain Severity Score based the Brief Pain Inventory-Short Form (BPI-SF) between start and end of each treatment period
The 4 pain intensity items (worst, least, average, and current pain) are rated on an 11-point numerical rating scale (0 = no pain, 10 = worst possible pain). A Pain Severity Score is calculated by adding the scores for the 4 items pertaining to pain intensity and then dividing this by 4. A higher number indicates higher levels of pain.
Measured: Baseline-4 weeks and weeks 6-10
Secondary outcomes (5)
Difference of the difference of the Pain Interference Score on BPI-SF between start and end of each treatment period
The BPI-SF pain interference subscale includes 7 items evaluating the impact of pain on sleep, mood, walking ability, general activity, work, relationships, and enjoyment of life over the past 1 week rated on an 11-point scale from 0 = does not interfere to 10 = completely interferes. A Pain Interference Score is calculated by adding the scores for the 7 items pertaining to pain interference and then dividing by 7. This gives an interference score from 0 to 10 (higher score indicating more interference)
Measured: Baseline-4 weeks and weeks 6-10
Difference of the difference of the average worst daily abdominal pain using a numeric rating scale (0-10) between start and end of each treatment period (baseline-4 weeks and weeks 6-10)
This will be based on using a numeric rating scale (0-10) with higher scores indicating more pain.
Measured: Baseline-4 weeks and weeks 6-10
Difference of the difference of the Change of Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) score between start and end of each treatment period
The COMPAT-SF carries 5 sub-scores for pain pattern, pain severity, pain provocation, pain spreading, and pain description, with higher scores denoting worse pain. Participants will complete 6 questions. A) The pain pattern scale ranges from 50-100; B) severity score ranges from 0-100; C) provocation score ranges from 0-70; D) spreading score ranges from 0-90 and E) description score ranges from 0-80. A total score ranges from 0-90 with higher scores denoting worse pain.
Measured: Baseline-4 weeks and weeks 6-10
Patient Global Impression of Change (PGIC) at end of each treatment period between the intervention group and sham group
PGIC is a 1-item survey that measures patient perceptions of intervention success. This uses a 7-point Likert scale that will be used to asses analgesic response to TEA: 1) very much improved; 2) much improved; 3) minimally improved; 4) no change; 5) minimally worse; 6) much worse; and 7) very much worse.
Measured: 4 weeks and 10 week
Predict difference of the difference of Pain Severity Score using pain widespreadedness at beginning of each treatment period
Baseline pain before each treatment period will be classified as 'localized' or 'widespread' using a body map. This will be used to predict change of pain severity score (pre minus post) assessed by BPI-SF.
Measured: Baseline-4 weeks and weeks 6-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start13 Jan 2025
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomly assigned in a 1:1 allocation ratio to one of two treatment sequences: i) active-TEA in treatment period 1 (week 1-4), followed by sham-TEA in treatment period 2 (week 7-10), or ii) sham-TEA in treatment period 1 (week 1-4), followed by active-TEA in treatment period 2 (week 7-10).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology
- Responsible party
- Principal investigator, Jorge Machicado, MD, MPH, University of Michigan
- Investigators
- Jorge D Machicado, MD, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721572
- Sponsor's protocol ID
- HUM00260188
- Other IDs
- 025780
- Acronym
- TEA-CuP
- Status last verified
- Mar 2026
- First submitted
- 3 Dec 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Patients With Chronic Pancreatitis (TEA-CuP): A Double-Blind, Sham-Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT06721572
- Acronym / sponsor ID
- TEA-CuP / HUM00260188
- Conditions
- Chronic Pancreatitis, Pancreatitis
- Keywords
- Abdominal Pain, Transcutaneous Electrical Acustimulation, Acupuncture, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American College of Gastroenterology
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcutaneous Electrical Acustimulation (TEA) is a noninvasive acupuncture method that can be self-administered at home without needles. TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions. This study will help elucidate if TEA is effective in treating abdominal pain in patients with painful chronic pancreatitis (CP).
Detailed description
Pain in patients with CP is debilitating and impairs quality of life. Despite using medical, endoscopic, or surgical treatments, many patients continue experiencing substantial pain and some are prescribed long-term opioids. This clinical trial aims to assess the analgesic effect of a mild electrical stimulator called TEA. TEA consists of a small, wearable device that can be used at-home while doing daily activities. If effective, this could be an alternative non-pharmacological and non-invasive option to manage pain related to CP.
In this study, the investigators will conduct a randomized, sham-controlled, 2x2 crossover trial in patients with painful CP. Subjects will be randomized to receive either active TEA first followed by sham TEA, or sham TEA first followed by active TEA. Other than the application point in the skin, active and sham TEA will be identical. The study will examine the effect of TEA on pain severity (primary outcome), pain interference and overall pain experience (secondary outcomes). The study will be conducted over 12 weeks in 5 periods: run-in (1 week), treatment period 1 (4 weeks), washout (2 weeks), treatment period 2 (4 weeks), and close-out visit (1 week). Subjects will complete online questionnaires about pain and health throughout the duration of the study. There will be a total of 3 study visits that will be conducted at the main Ann Arbor Hospital or virtually. All the study tasks can be completed remotely. The study will recruit patients from a single clinical center and from self-referral from patients with CP in the US. The proposed study will advance our understanding on the role of TEA for non-opioid pain management of CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned in a 1:1 allocation ratio to one of two treatment sequences: i) active-TEA in treatment period 1 (week 1-4), followed by sham-TEA in treatment period 2 (week 7-10), or ii) sham-TEA in treatment period 1 (week 1-4), followed by active-TEA in treatment period 2 (week 7-10).
| Arm | Type | Receives |
|---|---|---|
| Active TEA first followed by sham TEA | Experimental | Device: TEASubjects will undergo active TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then sham TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA. |
| Sham TEA first followed by active TEA | Experimental | Device: TEASubjects will undergo sham TEA for 4 weeks (week 1-4) followed by a 2-week washout period and then active TEA for 4 weeks (week 7-10). Subjects will have two instruction visits, one before starting active TEA and one before starting sham TEA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of definite or suspected Chronic Pancreatitis (CP). Definite CP features include presence of pancreatic calcifications or Cambridge grade 3-4 on imaging. Suspected CP features include presence of Rosemont criteria suggestive of CP on endoscopic ultrasound or 2 documented attacks of acute pancreatitis separated by at least 1 month without other definite or suspected CP features.
- Abdominal pain that is present for at least 3 months prior to enrollment and having experienced moderate intensity abdominal pain (rated as 4 or higher on a 0-10 Numeric Rating Scale) at least once in the last month.
Key exclusion criteria (19 listed)
- Breastfeeding mother
- Pregnant or intending to become pregnant within the next 3 months
- Incarcerated individuals
- Unwillingness or inability to consent
- Unable to read and speak English precluding completion of questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAActive TEA or sham TEA will be self-administered at home over two daily treatment sessions of 30 minutes each in the morning and evening. Active TEA will be delivered through an active stimulation acupoint that has previously shown to reduce abdominal pain in other patient populations. Sham TEA will be administered at a different point a few cm away from the active site and that has been shown to be ineffective in reducing pain. Other than the location, the anatomical location, application of TEA and sham will be identical. The device will be programmed by the study team to generate fixed frequency, pulse width, and time on/time off during the pulsed stimulation. The subject is only able to change the stimulation output in a range from 0-10 milliampere. | Device | Active TEA first followed by sham TEA, Sham TEA first followed by active TEA |
Primary outcome
Difference of the difference of the Pain Severity Score based the Brief Pain Inventory-Short Form (BPI-SF) between start and end of each treatment period
Time frame: Baseline-4 weeks and weeks 6-10
The 4 pain intensity items (worst, least, average, and current pain) are rated on an 11-point numerical rating scale (0 = no pain, 10 = worst possible pain). A Pain Severity Score is calculated by adding the scores for the 4 items pertaining to pain intensity and then dividing this by 4. A higher number indicates higher levels of pain.
5 secondary outcomes
Difference of the difference of the Pain Interference Score on BPI-SF between start and end of each treatment period
Time frame: Baseline-4 weeks and weeks 6-10
Difference of the difference of the average worst daily abdominal pain using a numeric rating scale (0-10) between start and end of each treatment period (baseline-4 weeks and weeks 6-10)
Time frame: Baseline-4 weeks and weeks 6-10
Difference of the difference of the Change of Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) score between start and end of each treatment period
Time frame: Baseline-4 weeks and weeks 6-10
Patient Global Impression of Change (PGIC) at end of each treatment period between the intervention group and sham group
Time frame: 4 weeks and 10 week
Predict difference of the difference of Pain Severity Score using pain widespreadedness at beginning of each treatment period
Time frame: Baseline-4 weeks and weeks 6-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge D Machicado, MD, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEA in people with Chronic Pancreatitis and Pancreatitis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the difference of the Pain Severity Score based the Brief Pain Inventory-Short Form (BPI-SF) between start and end of each treatment period (time frame: Baseline-4 weeks and weeks 6-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.