A Pilot Study of Scrambler Therapy for Painful Chronic Pancreatitis
Johns Hopkins University
Summary
The investigators will enroll adults with chronic pancreatitis who have persistent abdominal pain not relieved by standard treatments. This study will test the feasibility and effectiveness of Scrambler Therapy, a non-invasive FDA-cleared device that delivers "non-pain" electrical signals through the skin to retrain the brain's pain perception. Participants will undergo 5-10 treatment sessions and be followed for 3 months with standardized pain scores and quality-of-life assessments. The goal is to generate pilot data to support larger studies of Scrambler Therapy as a novel option for pancreatic pain.
Description
This is a single-arm, observational pilot study to test whether Scrambler Therapy (ST) is a feasible and effective treatment for refractory abdominal pain in chronic pancreatitis. Approximately 40 adults with Chronic Pancreatitis (CP) will be enrolled through outpatient clinics and inpatient consults. Eligible participants are those who continue to experience significant pain despite medical and/or endoscopic or surgical management. After informed consent, participants will undergo 5-10 daily Scrambler Therapy sessions lasting 30-40 minutes each. Electrodes will be placed on skin areas near,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 18 years and older * Diagnosis of chronic pancreatitis with refractory abdominal pain * Able to provide written informed consent in English * Sufficient English language ability to complete study questionnaires * Reliable and regular access to a phone for follow-up Exclusion Criteria: * Unable or unwilling to provide written consent * History or presence of a significant medical or psychiatric condition that would interfere with study participation * Pregnant or lactating women * Coronary stents or implanted metallic/electrical devices (pacemaker, defibrill…
Interventions
- DeviceScrambler Therapy
Adults with chronic pancreatitis and refractory abdominal pain will receive Scrambler Therapy, a non-invasive neuromodulation device. Electrodes are placed near the painful area to deliver "non-pain" signals aimed at reducing pain perception. Participants will complete 5-10 daily treatment sessions, each lasting 30-40 minutes, with pain ratings collected before and after sessions and follow-up assessments over 3 months.
Location
- Johns Hopkins Green Spring StationBaltimore, Maryland