Effectiveness of Electrical Neurostimulation as an Opioid-Sparing Alternative in the Treatment of Cyclic Vomiting Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Severity of Abdominal Pain
研究概览
简要总结
We hypothesize that 1) Neurostimulation via a novel auricular percutaneous electrical nerve field stimulation (PENFS) device is a safe, non-invasive opioid-sparing alternative therapy for severe abdominal pain, nausea, and vomiting associated with CVS and will reduce the need for opioids. We also hypothesize that 2) PENFS reduces the length of stay (LOS), and improves patient satisfaction. We propose the following specific aim:
Aim 1. Investigate the efficacy of PENFS compared to a sham in patients with CVS seen in the ED or in the clinic or hospitalized with an acute CVS episode.
Objectives:
- Demonstrate reduction in abdominal pain, nausea, and vomiting using validated tools.
- Obviate or reduce the need for opioids.
- Reduce the length of hospital stay and improve patient satisfaction.
This approach will specifically address the current opioid problem using a novel, non-invasive neurostimulation therapy with proven efficacy for opioid withdrawal. Long-term, it may improve health care outcomes and significantly reduce overall health care costs.
详细描述
Opioid use in CVS and the critical need for opioid sparing therapy
Given the lack of knowledge about pathophysiology and evidence-based therapies, patients are often hospitalized to treat symptoms of CVS. During an episode, patients present with severe vomiting and abdominal pain and are treated empirically with IV fluids, antiemetics, benzodiazepines, and opioids. Estimates of opioid use range from 23%-27% in adults with CVS. Patients are often dissatisfied with the level of analgesia as recurrent opioid use results in tolerance and dependence. This often undermines the physician-patient relationship and patients even leave against medical advice out of frustration with what they perceive as ineffective care. This can lead to worse outcomes including recurrent hospitalizations, morbidity and increased health care costs.
Preliminary data from a study by our group reveals that of 101 patients hospitalized with CVS at Froedtert Hospital, chronic opioid therapy is associated with a two-fold increased risk of hospitalization (RR 2.22, CI 1.1-4.4, P=0.02) and three-fold increase in hospital length of stay (LOS) (RR 3.43, CI 1.26-9.34, P=0.01). In a study of 132 CVS patients, opioid use was associated with non-response to amitriptyline (53% vs 15%, p<0.05), a prophylactic therapy used in CVS. This in turn was associated with increased frequency and duration of CVS episodes per year and increased number of hospitalizations/emergency department (ED) visits at baseline (18% vs 15.2%, p<0.05). Hence there is an urgent need for an opioid-sparing, non-invasive strategy to treat CVS symptoms.
In summary, CVS is common and disabling and is associated with significant health care costs. Our proposed project using a novel, non-invasive device to treat CVS will also address the current opioid crisis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet Rome criteria for cyclic vomiting syndrome and are in an acute episode.
排除标准
- •Developmental delay
- •Non-English speaking patients
- •Pregnancy
- •Any implanted electrical device
- •Any significant dermatological/infectious condition of the ear
研究组 & 干预措施
Intervention group
The Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.
干预措施: The Bridge device (Device)
Placebo Group
The sham is similar in appearance to the Bridge device but does not deliver any electrical stimulation and is a sham that is designed to look identical to the Bridge device. It is placed on the external ear at the beginning of the study and removed by the patient after 5 days.
干预措施: The Bridge device (Device)
结局指标
主要结局
Change in Severity of Abdominal Pain
时间窗: The change in abdominal pain will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.
Abdominal pain will be assessed through Visual Analog Scale with the score of ranging from 0 to 10, with 0 being the least and 10 being the worst pain.
Change in Need for Opioids Between Device and Sham
时间窗: The dose of opioids use ( morphine equivalent) will be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.
The amount of opioids used by the patient will be recorded in all subjects and will be converted into morphine equivalents for comparison
次要结局
- Change in Index for Nausea, Vomiting and Retching (INVR) Scores(The INVR scores will be assessed be measured at baseline (before intervention) and then at 2 hours, 24 hours and at 5 days post intervention.)
- Length of Stay in the Hospital (LOS)(LOS will be determined at end of 1 month)
- Patient Satisfaction(Patient satisfaction will be assessed at end of 1 month)
研究者
Thangam Venkatesan
Professor
Medical College of Wisconsin