Patterned Multichannel Vibratory Coordinated Reset (VCR) Stimulation for the Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment Responder
研究概览
简要总结
The purpose of this study is to perform a first in man study with VCR stimulation of the belly and back for patients with chronic pain conditions including pelvic pain, functional abdominal pain, or low back pain. This study will also examine VCR stimulation of the temporal region for patients with migraine with or without aura. Additional goals of the study will be to determine the safety, tolerability, and acceptability of VCR stimulation for the treatment of these pain conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age greater than or equal to 18 years old.
- •Diagnosis of either chronic pelvic pain, functional abdominal pain, axial low back pain, or migraine with or without aura of at least 3 months duration.
- •English speaking
- •Ability and willingness to complete questionnaires and in-person assessments
- •Current average daily pain score of greater than or equal to 4 on the Numeric Rating Scale of Pain (0-10 scale)
- •For patients with migraine diagnosis they must report at least 2 headaches in the baseline headache diary in the 30 days preceding randomization.
排除标准
- •Any conditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)
- •Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
- •Any suicidality as assessed by answer of greater than 0 on question 9 the PHQ-9 assessing suicidal thoughts.
- •Any current illicit drug or alcohol abuse.
- •Any history of recurrent or unprovoked seizures.
- •Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days.
- •Pregnancy, breast-feeding or lack of reliable contraception
- •Changes in pain medications in the previous 4 weeks
- •Implanted electrical stimulation device.
- •Skin infection over stimulation sites.
- •Any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks) Any botulinum toxin injection in the previous 3 months
- •For patients with migraine diagnosis additional exclusion criteria include receipt of preventive anti-migraine treatment in the past 3 months, failure on greater than or equal to 3 well-conducted preventive drug trials, concurrent medication overuse headache diagnosis, and concurrent frequent/chronic tension type headache.
- •4. Frequent/chronic tension type headache
研究组 & 干预措施
Vibrotactile Stimulation
干预措施: Vibrotactile Stimulation (Device)
Sham Stimulation
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Treatment Responder
时间窗: 30 days
Proportion of subjects in the treatment vs. placebo groups that are responders with greater than or equal to 50% reductions in average pain (in the primary pain area) comparing the average pain score from the 7-day baseline diary pre-treatment to the average scores based on 7-day diaries at the end of the primary outcome interval
Change in Opioid Use
时间窗: 30 days
Change in opioid use in daily oral morphine equivalents from the average 7-day baseline use to the post-treatment use in the 7 days at the end of the primary outcome interval.
次要结局
- Adverse Events(60 days)
- Secondary Treatment Response After Crossover(60 days)
- Change in monthly migraine days(30 days)
- Treatment Engagement(30 days)
- Treatment Initiation(30 days)
研究者
Jennifer Hah
Assistant Professor
Stanford University