Scrambler Therapy in Chronic Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Scrambler Therapy.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Pancreatitis, Chronic Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study of Scrambler Therapy for Painful Chronic Pancreatitis
Overview
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.
Interventions
- Device Scrambler 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.
Primary outcome measures
- Feasibility as assessed by enrollment rate [Time frame: During recruitment ( expected 24 months)]
- Feasibility as assessed by treatment adherence [Time frame: During treatment period (up to 2 weeks)]
- Feasibility as assessed by treatment adherence rate [Time frame: During treatment period (average 5-10 days, up to 2 weeks)]
- Feasibility as assessed by retention [Time frame: Baseline through 3 months post-treatment]
Secondary outcome measures (11)
- Change in Pain Intensity (VAS) [Time frame: Baseline, 1 month, and 3 months after treatment]
- Percentage of Patients with ≥30% Pain Reduction [Time frame: Baseline , 1 months and 3 months post-treatment]
- Percentage of Patients with ≥50% Pain Reduction [Time frame: Baseline, 1 month and 3 months post-treatment]
- Opioid use [Time frame: Baseline, 1 month and 3 months post-treatment]
- Daily opioid dose( morphine milligram equivalents,MME) [Time frame: Baseline, 1 month and 3 months post-treatment]
- Patient Global Impression of Change (PGIC) [Time frame: 1 month, 3 months]
- Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale. [Time frame: Baseline, 1 month, and 3 months after treatment]
- Change from baseline on the Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline, 1 month, and 3 months post-treatment]
- Change from baseline on the Modified Brief Pain Inventory Short Form [Time frame: Baseline, 1 month and 3 months]
- Change from baseline on the European Organization for the Research and Treatment of Cancer Quality(EORTC) of Life Questionnaire (QLQ) Core 30 (C30) [Time frame: Baseline, 1 month and 3 months]
- Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF) [Time frame: Baseline, 1 month and 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins Green Spring Station — Baltimore
Identifiers
NCT: NCT07174609 · IRB00469056