Scrambler Therapy in Chronic Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Scrambler Therapy
DeviceAdults 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Scrambler Therapy for Chronic Pancreatitis PainExperimental treatment 1 intervention
Trial outcomes
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-treatmentSecondary 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 treatment2
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-treatment3
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-treatment4
Opioid use
Number of patients using prescription opioids for pain control at time of assessment
Time frame
Baseline, 1 month and 3 months post-treatmentOther 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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
The National Pancreas Foundation
Collaborator
Source ClinicalTrials.gov