An interventional study of Scrambler Therapy in Chronic Pain, Pancreatitis and Chronic Pancreatitis, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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.
Feasibility as assessed by enrollment rate
Number of eligible patients who consent and enroll divided by the total number of eligible patients approached.
Time frame: During recruitment ( expected 24 months)
Feasibility as assessed by treatment adherence
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.
Time frame: During treatment period (up to 2 weeks)
Feasibility as assessed by treatment adherence rate
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.
Time frame: During treatment period (average 5-10 days, up to 2 weeks)
Feasibility as assessed by retention
Proportion of enrolled participants who complete the 3-month follow-up assessments, including pain ratings.
Time frame: Baseline through 3 months post-treatment
Change in Pain Intensity (VAS)
Change in abdominal pain severity measured by Visual Analogue Scale (VAS, 0-10).Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain).
Time frame: Baseline, 1 month, and 3 months after treatment
Percentage of Patients with ≥30% Pain Reduction
Percentage of participants achieving at least a 30% reduction in VAS pain score compared with baseline.
Time frame: Baseline , 1 months and 3 months post-treatment
Percentage of Patients with ≥50% Pain Reduction
Percentage of participants achieving at least a 50% reduction in VAS pain score compared with baseline.
Time frame: Baseline, 1 month and 3 months post-treatment
Opioid use
Number of patients using prescription opioids for pain control at time of assessment
Time frame: Baseline, 1 month and 3 months post-treatment
Daily opioid dose( morphine milligram equivalents,MME)
Change in mean daily prescription opioid dose reported by participants, converted to morphine milligram equivalents.
Time frame: Baseline, 1 month and 3 months post-treatment
Patient Global Impression of Change (PGIC)
PGIC is a 7-point Likert scale (1 = very much improved, 7 = very much worse).
Time frame: 1 month, 3 months
Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale.
Change from baseline in PROMIS Global Health, which provides physical and mental health scores (range 7-35; higher = better health).
Time frame: Baseline, 1 month, and 3 months after treatment
Change from baseline on the Hospital Anxiety and Depression Scale (HADS)
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).
Time frame: Baseline, 1 month, and 3 months post-treatment
Change from baseline on the Modified Brief Pain Inventory Short Form
Change from baseline in mBPI-SF. Pain severity score range 0-40; pain interference score range 0-70. Higher = worse pain or more interference.
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)
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.
Time frame: Baseline, 1 month and 3 months
Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)
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.
Time frame: Baseline, 1 month and 3 months
Adverse events - Frequency
Frequency of treatment-related adverse events, including skin irritation or discomfort at electrode sites.
Time frame: During treatment ( up to 2 weeks)
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University