Scrambler Therapy in Chronic Pancreatitis

Johns Hopkins University

Status: Enrolling

Conditions: Chronic Pancreatitis; Pancreatitis; Chronic Pain

Treatments: Device: Scrambler Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07174609

IRB00469056

Details and patient eligibility

About

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.

Full 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, but not directly over, the sites of pain. Treatment intensity will be adjusted until patients perceive a tolerable, tingling "non-pain" sensation. Pain ratings (0-10 visual analogue scale, VAS) will be collected before and after each session.

Participants will be followed for 3 months, with weekly pain ratings collected via text, phone, or email, and standardized questionnaires at 3 months. Secondary outcomes include opioid use, 30% and 50% pain reduction, and patient-reported outcomes (PROMIS tools and Patient Global Impression of Change). Safety will be monitored by recording any adverse events, with particular attention to mild skin irritation at electrode sites.

The primary goal is to determine the feasibility of enrolling and retaining patients and their willingness to complete treatment and follow-up. If Scrambler Therapy shows promise, these data will support the design of larger controlled trials aimed at improving pain management for patients with chronic pancreatitis.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, defibrillator, aneurysm clips)
• History of epilepsy, traumatic brain injury, or myocardial infarction within the past 6 months
• Skin conditions preventing electrode placement (e.g., open wounds)
• Any condition that, in the investigator's opinion, places the participant at increased risk or prevents full compliance with study procedures

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Scrambler Therapy for Chronic Pancreatitis Pain

Experimental group

Description:

Adults with chronic pancreatitis and refractory abdominal pain will receive Scrambler therapy. Scrambler Therapy is a non-invasive neuromodulation treatment designed to relieve chronic pain by transmitting "non-pain" electrical signals through the skin to the nervous system. The device generates 16 variable waveforms that mimic natural nerve impulses, creating patient-specific cutaneous electrostimulation. These signals are carried by afferent C-fibers and interpreted by the central nervous system as non-painful, thereby modulating pain perception rather than blocking it.

Treatment:

Device: Scrambler Therapy