ClinicalTrials.gg
RecruitingNCT07174609Updated Sep 29, 2026

Scrambler Therapy in Chronic Pancreatitis

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

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2024, registered Sep 2025).
  • Started Nov 2024; still recruiting 2 years later.
Updated Sep 29, 2026Study completion movedGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 11 studies in Chronic Pain by Johns Hopkins University — 4 open to participants now, 4 under way, none of them phase 3. Chronic Pain · Johns Hopkins University.

Started
2024
with 2 others
No phase
5 of 11
3 open now
Registered
10th of 11
by date

Among the 11 studies in Chronic Pain by Johns Hopkins University, this one is one of 3 that started in 2024, is one of 5 with no phase, and was the 10th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

4 of the 11 studies in Chronic Pain by Johns Hopkins University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Get alerts for this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Chronic Pain by Johns Hopkins University, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Chronic Pain
  • Pancreatitis
  • Chronic Pancreatitis

Keywords

  • chronic pain
  • Abdominal pain
  • chronic pancreatitis
  • Scrambler Therapy
  • Electrocutaneous analgesia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years and older
  • Diagnosis of chronic pancreatitis with abdominal pain
  • Able to provide written in English
  • Sufficient English language ability to complete study questionnaires
  • Reliable and regular access to a phone for follow-up

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Scrambler Therapy for Chronic Pancreatitis Pain

    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

Interventions

  • DeviceScrambler 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.

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Other outcomes

  1. 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)

07

Study locations

1 of 1 sites recruiting
  • Johns Hopkins Green Spring Station
    Baltimore, Maryland 21205, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 25 months is above that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

Completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Dec 2027, on Sep 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2025
First posted
Sep 16, 2025
StartActual
Nov 1, 2024
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 1, 2027was Dec 2026
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Study completion
Dec 1, 2026→Dec 1, 2027
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Study completion Dec 1, 2026→Dec 1, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07174609
Collaborators
The National Pancreas Foundation
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Nov 1, 2024
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Mahya Faghih
Contact
mfaghih2@jh.edu
443-287-4680
Mahya Faghih
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion