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
Overview
- Phase
- Not Applicable
- Intervention
- TEA
- Conditions
- Chronic Pancreatitis
- Sponsor
- University of Michigan
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last month
Overview
Brief 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. 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.
Investigators
Jorge Machicado, MD, MPH
Assistant Professor of Internal Medicine
University of Michigan
Eligibility Criteria
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.
Arms & Interventions
Active TEA first followed by sham TEA
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.
Intervention: TEA
Sham TEA first followed by active TEA
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.
Intervention: TEA
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Difference of the difference of the Pain Interference Score on BPI-SF between start and end of each treatment period(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)(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(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(4 weeks and 10 week)
- Predict difference of the difference of Pain Severity Score using pain widespreadedness at beginning of each treatment period(Baseline-4 weeks and weeks 6-10)