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NCT Number: NCT07174609

Scrambler Therapy in Chronic Pancreatitis

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.

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Key information

Conditions

Chronic Pain Abdominal Pain Chronic Disease Chronic Pancreatitis Digestive System Diseases Disease Attributes Neurologic Manifestations Pain Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Green Spring Station

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Mahya Faghih, MD

CONTACT

[email protected]

443-287-4680

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scrambler Therapy

Device

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 outcomes

  1. Feasibility as assessed by enrollment rate

    Time frame: During recruitment ( expected 24 months)

    Number of eligible patients who consent and enroll divided by the total number of eligible patients approached.

  2. Feasibility as assessed by treatment adherence

    Time frame: 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.

  3. Feasibility as assessed by treatment adherence rate

    Time frame: 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.

  4. Feasibility as assessed by retention

    Time frame: Baseline through 3 months post-treatment

    Proportion of enrolled participants who complete the 3-month follow-up assessments, including pain ratings.

Secondary outcomes

  1. Change in Pain Intensity (VAS)

    Time frame: 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).

  2. Percentage of Patients with ≥30% Pain Reduction

    Time frame: Baseline , 1 months and 3 months post-treatment

    Percentage of participants achieving at least a 30% reduction in VAS pain score compared with baseline.

  3. Percentage of Patients with ≥50% Pain Reduction

    Time frame: Baseline, 1 month and 3 months post-treatment

    Percentage of participants achieving at least a 50% reduction in VAS pain score compared with baseline.

  4. Opioid use

    Time frame: Baseline, 1 month and 3 months post-treatment

    Number of patients using prescription opioids for pain control at time of assessment

  5. Daily opioid dose( morphine milligram equivalents,MME)

    Time frame: Baseline, 1 month and 3 months post-treatment

    Change in mean daily prescription opioid dose reported by participants, converted to morphine milligram equivalents.

  6. Patient Global Impression of Change (PGIC)

    Time frame: 1 month, 3 months

    PGIC is a 7-point Likert scale (1 = very much improved, 7 = very much worse).

  7. 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 in PROMIS Global Health, which provides physical and mental health scores (range 7-35; higher = better health).

  8. Change from baseline on the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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).

  9. Change from baseline on the Modified Brief Pain Inventory Short Form

    Time frame: 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.

  10. 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 in European Organization for Research and Treatment of Cancer QLQ-C30 (0-100). Higher = better on global/functioning scales; higher = worse on symptom scales.

  11. Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)

    Time frame: 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.

Other outcomes

  1. Adverse events - Frequency

    Time frame: During treatment ( up to 2 weeks)

    Frequency of treatment-related adverse events, including skin irritation or discomfort at electrode sites.

Study contacts

Contact information is provided by the study sponsor or research team.

Mahya Faghih

CONTACT

[email protected]

443-287-4680

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • The National Pancreas Foundation

Registry information

Official study title

A Pilot Study of Scrambler Therapy for Painful Chronic Pancreatitis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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