Scrambler Therapy in Chronic Pancreatitis

Not Applicable

Recruiting

• Conditions: Chronic Pain; Pancreatitis; Chronic Pancreatitis

• Registration Number: NCT07174609
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by enrollment rate	During recruitment ( expected 24 months)	Number of eligible patients who consent and enroll divided by the total number of eligible patients approached.
Feasibility as assessed by treatment adherence	During treatment period (up to 2 weeks)	Number of participants who complete a minimum of 5 Scrambler Therapy sessions out of the planned 5-10, or who discontinue earlier due to achieving adequate pain relief.
Feasibility as assessed by treatment adherence rate	During treatment period (average 5-10 days, up to 2 weeks)	Proportion of participants who complete a minimum of 5 Scrambler Therapy sessions out of the planned 5-10, or who discontinue earlier due to achieving adequate pain relief.
Feasibility as assessed by retention	Baseline through 3 months post-treatment	Proportion of enrolled participants who complete the 3-month follow-up assessments, including pain ratings.

Secondary Outcome Measures

Name	Time	Method
Opioid use	Baseline, 1 month and 3 months post-treatment	Number of patients using prescription opioids for pain control at time of assessment
Percentage of Patients with ≥30% Pain Reduction	Baseline , 1 months and 3 months post-treatment	Percentage of participants achieving at least a 30% reduction in VAS pain score compared with baseline.
Change in Pain Intensity (VAS)	Baseline, 1 month, and 3 months after treatment	Change in abdominal pain severity measured by Visual Analogue Scale (VAS, 0-10).Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain).
Percentage of Patients with ≥50% Pain Reduction	Baseline, 1 month and 3 months post-treatment	Percentage of participants achieving at least a 50% reduction in VAS pain score compared with baseline.
Daily opioid dose( morphine milligram equivalents,MME)	Baseline, 1 month and 3 months post-treatment	Change in mean daily prescription opioid dose reported by participants, converted to morphine milligram equivalents.
Patient Global Impression of Change (PGIC)	1 month, 3 months	PGIC is a 7-point Likert scale (1 = very much improved, 7 = very much worse).
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale.	Baseline, 1 month, and 3 months after treatment	Change from baseline in PROMIS Global Health, which provides physical and mental health scores (range 7-35; higher = better health).
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)	Baseline, 1 month, and 3 months post-treatment	The HADS is a validated self-reported tool that screens for symptoms of anxiety and depression. Possible scores range from 0 to 21 (higher scores reflect more severe symptoms of anxiety or depression).
Change from baseline on the Modified Brief Pain Inventory Short Form	Baseline, 1 month and 3 months	Change from baseline in mBPI-SF. Pain severity score range 0-40; pain interference score range 0-70. Higher = worse pain or more interference.
Change from baseline on the European Organization for the Research and Treatment of Cancer Quality(EORTC) of Life Questionnaire (QLQ) Core 30 (C30)	Baseline, 1 month and 3 months	Change from baseline in European Organization for Research and Treatment of Cancer QLQ-C30 (0-100). Higher = better on global/functioning scales; higher = worse on symptom scales.
Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)	Baseline, 1 month and 3 months	Change from baseline in COMPAT-SF. The COMPAT-SF is a validated self-reported tool specifically designed for patients with pancreatic disease. Scores for pain severity (average, worst, and least) range from 0 to 10 (higher corresponds to more pain); scores for pain triggers (including food, exercise, and thermal changes) are scored on a scale from never to always (never, rarely, sometimes, very often, always); scores for pain symptom characteristics (cramping, shooting, stabbing) are scored on a scale from 0 (none) to 10 (worst possible). The total score is a weighted score derived from individual dimension scores which are then normalized to a 0-100 scale.

Trial Locations

Locations (1)

Johns Hopkins Green Spring Station; 🇺🇸 Baltimore, Maryland, United States