A Pilot Study of Scrambler Therapy for Painful Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility as assessed by enrollment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility as assessed by enrollment rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline through 3 months post-treatment
Proportion of enrolled participants who complete the 3-month follow-up assessments, including pain ratings.
次要结局
- Opioid use(Baseline, 1 month and 3 months post-treatment)
- Change from baseline on the Modified Brief Pain Inventory Short Form(Baseline, 1 month and 3 months)
- Percentage of Patients with ≥30% Pain Reduction(Baseline , 1 months and 3 months post-treatment)
- Change in Pain Intensity (VAS)(Baseline, 1 month, and 3 months after treatment)
- Percentage of Patients with ≥50% Pain Reduction(Baseline, 1 month and 3 months post-treatment)
- Daily opioid dose( morphine milligram equivalents,MME)(Baseline, 1 month and 3 months post-treatment)
- Patient Global Impression of Change (PGIC)(1 month, 3 months)
- Change from baseline on the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale.(Baseline, 1 month, and 3 months after treatment)
- Change from baseline on the Hospital Anxiety and Depression Scale (HADS)(Baseline, 1 month, and 3 months post-treatment)
- Change from baseline on the European Organization for the Research and Treatment of Cancer Quality(EORTC) of Life Questionnaire (QLQ) Core 30 (C30)(Baseline, 1 month and 3 months)
- Change from baseline on the Comprehensive Pain Assessment Tool for Pancreatitis Short Form (COMPAT-SF)(Baseline, 1 month and 3 months)