Role of Home-Based Transcutaneous Electrical Acustimulation for Treatment of Pain in Subjects With Chronic Pancreatitis (TEA-CuP)

University of Michigan

Status: Enrolling

Conditions: Chronic Pancreatitis; Pancreatitis

Treatments: Device: TEA

Study type: Interventional

Funder types: Other

Identifiers

NCT06721572

HUM00260188

025780 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups

Active TEA first followed by sham TEA

Experimental group

Description:

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.

Treatment:

Device: TEA

Sham TEA first followed by active TEA

Experimental group

Description:

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.

Treatment:

Device: TEA