Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in global abdominal pain
研究概览
简要总结
This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.
详细描述
The aim of this study is to investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C). The study also aims to compare the electrical neuromodulation therapy (TEA) with medical neuromodulation therapy (escitalopram) in their ability to treat abdominal pain and improve the autonomic dysfunction in participants with IBS-C. This project will investigate the impact of 3 active treatment interventions vs. a sham control intervention on abdominal pain and other IBS symptoms in participants with IBS-C. This is a parallel-group study in which the participants will be divided into 4 treatment groups designed to investigate the feasibility of TEA using optimized parameters in comparison with medical neuromodulation therapy (escitalopram) and sham-TEA. The treatment will be home-based and last for a period of 8 weeks. To preserve scientific integrity and effective masking, certain details of arms and interventions will be made more precise upon or prior to reporting results
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
One quarter of participants will be in each arm. Those randomized to device arms will not be informed of their parameters. Those in the drug arm will be informed of their arm soon after randomization.
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
- •Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
- •Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period
- •Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis.
- •Abdominal pain is not adequately relieved at the time of screening and the time of randomization.
排除标准
- •Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
- •Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation.
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
- •A history of abdominal surgery (other than cholecystectomy or appendectomy)
- •Active use of prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotic (e.g., Seroquel, Risperdal), antidiarrheal, or frequent (>2 days/week) use of opioid or antispasmodic medication. Those who frequently use Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) will also be excluded.
- •Ongoing use of Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), or any other serotonin-active medications, including tricyclic antidepressants (TCAs). Individuals on chronic SSRI therapy, including escitalopram, at the initial evaluation will not be enrolled in the study.
- •Inability to avoid the following medications: tricyclic antidepressants, Monoamine Oxidase (MAO) inhibitors including, intravenous methylene blue, linezolid, and pimozide, as well as triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort. - - Participants will be informed that MAO inhibitors cannot be used within 14 days of starting or stopping escitalopram.
- •Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations.
- •Known allergy to adhesive Electrocardiogram (ECG) electrodes.
- •Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts.
- •Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above).
研究组 & 干预措施
TEA at location A
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
干预措施: TEA (Device)
TEA at location B
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
干预措施: TEA (Device)
TEA at location C
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
干预措施: TEA (Device)
Escitalopram treatment
This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.
干预措施: Lexapro (Drug)
结局指标
主要结局
Change in global abdominal pain
时间窗: Weekly for 14 weeks
Participants will complete a weekly VAS survey to monitor for change in discomfort for the week prior when compared to prior to starting the study. This contains two questions which ask yes/no questions asking about improvement over the prior week, and one question asking for satisfaction of improvement from 0 to 5, 0 being the lowest (not satisfied) and 5 being the highest (very satisfied). These answers will be compared from week 1 to week 14.
Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey
时间窗: Daily for 14 weeks
Participants will complete a daily VAS survey to measure daily discomfort. There are four metrics measured in this form, abdominal pain, abdominal bloating, abdominal fullness, and abdominal cramping. These are scored on a line from 0 to 10, with 0 being the lowest (no pain) and 10 being the highest (worst imaginable pain) These scores will be totaled each day and compared from day 0 to day 98, or the end of week 14.
次要结局
- Daily Stool Diary - Change in number of bowel movements(Daily for 14 weeks)
- Daily Stool Diary - Change in Bristol Stool Form Scale (BSFS)(Daily for 14 weeks)
- Daily Stool Diary - Change sense of urgency(Daily for 14 weeks)
- Change in Bowel Habits Per Separate IBS-SSS Survey(Once every 10 days for 14 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety(Weekly for 14 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS) - Depression(Weekly for 14 weeks)
- Daily Stool Diary - Change in abdominal bloating(Daily for 14 weeks)
- Change in quality of life via Irritable Bowel Syndrome - Quality of Life (IBS-QOL) survey(Weekly for 14 weeks)
- Change in IBS - Symptom Severity Score (IBS-SSS)(Once every 10 days for 14 weeks)
研究者
Borko Nojkov
Assistant Professor - Specialty Gastroenterology, Internal Medicine
University of Michigan