Chronic PainNCT07174609
Scrambler Therapy in Chronic Pancreatitis
A study testing Scrambler Therapy in people with Chronic Pain and Pancreatitis, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Pancreatitis, Chronic Pancreatitis
- What is being tested?
- Scrambler Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Green Spring Station
Baltimore, Maryland, 21205
Mahya Faghih, MD, 443-287-4680, mfaghih2@jh.edu
About this study
Official title: A Pilot Study of Scrambler Therapy for Painful 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.
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.
- Conditions
- Chronic Pain, Pancreatitis, Chronic Pancreatitis
- Being tested
- Scrambler Therapy
- Keywords
- chronic pain, Abdominal pain, chronic pancreatitis, Scrambler Therapy, Electrocutaneous analgesia
- Medical subject headings
- Chronic Pain, Pancreatitis, Pancreatitis, Chronic, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scrambler TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Scrambler Therapy for Chronic Pancreatitis Pain | Experimental | 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. Receives: Device: Scrambler Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by enrollment rate
Number of eligible patients who consent and enroll divided by the total number of eligible patients approached.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through 3 months post-treatment
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month and 3 months post-treatment
Opioid use
Number of patients using prescription opioids for pain control at time of assessment
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Nov 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm feasibility study using a Single Group Assignment design. All participants with chronic pancreatitis and refractory abdominal pain will receive Scrambler Therapy, consisting of 5-10 daily treatment sessions lasting 30-40 minutes. There is no randomization or control arm. Outcomes will include feasibility measures (enrollment, adherence, and retention), as well as changes in pain severity, opioid use, and patient-reported quality of life over 3 months of follow-up. The purpose is to generate preliminary safety and effectiveness data to support future controlled trials.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- The National Pancreas Foundation
- Responsible party
- Sponsor
- Investigators
- Mahya Faghih, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174609
- Sponsor's protocol ID
- IRB00469056
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Scrambler Therapy for Painful Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT07174609
- Acronym / sponsor ID
- IRB00469056
- Conditions
- Chronic Pain, Pancreatitis, Chronic Pancreatitis
- Keywords
- chronic pain, Abdominal pain, chronic pancreatitis, Scrambler Therapy, Electrocutaneous analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- The National Pancreas Foundation
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm feasibility study using a Single Group Assignment design. All participants with chronic pancreatitis and refractory abdominal pain will receive Scrambler Therapy, consisting of 5-10 daily treatment sessions lasting 30-40 minutes. There is no randomization or control arm. Outcomes will include feasibility measures (enrollment, adherence, and retention), as well as changes in pain severity, opioid use, and patient-reported quality of life over 3 months of follow-up. The purpose is to generate preliminary safety and effectiveness data to support future controlled trials.
| Arm | Type | Receives |
|---|---|---|
| Scrambler Therapy for Chronic Pancreatitis Pain | Experimental | Device: Scrambler TherapyAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scrambler TherapyAdults 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. | Device | Scrambler Therapy for Chronic Pancreatitis Pain |
Primary outcome
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.
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.
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.
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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahya Faghih principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scrambler Therapy in people with Chronic Pain and Pancreatitis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahya Faghih (443-287-4680, mfaghih2@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as assessed by enrollment rate (time frame: During recruitment ( expected 24 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.