Effect of Cranial Electrotherapy Stimulation on PTSD in Burned Outpatients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score
研究概览
简要总结
To find out if Cranial Electrotherapy Stimulation is a useful treatment for people who have been burned and have Post Traumatic Stress Disorder. CES may be helpful in giving relief to some or all of those symptoms.
详细描述
The purpose of this research study is to systematically determine if CES therapy is effective in managing post traumatic stress disorder (PTSD) in the burn patient. Cranial Electrotherapy Stimulation (CES) is the delivery of low-level electrical stimulation across the head, delivered with ear lobe electrode clips or self-adhesive electrode pads. CES in the current form has been used for the past 30 years to successfully treat anxiety, depression, insomnia and pain in a variety of patient populations. This FDA approved medical device is non-invasive and has no reported significant side effects. It will be used on patients undergoing outpatient rehabilitation in our burn center.
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
- 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
- •burned patients requiring outpatient physical or occupational therapy in the USAISR Burn Rehabilitation Gym or Center for the Intrepid
- •Able to read and speak English
- •Between ages of 18-65 years
- •Screen positive (score greater than 44) on the PCL-M/C instruments
排除标准
- •pregnant patients
- •patients with implantable pacemakers or electronic stimulators
- •patients scoring below 44 on the PCL-M/C instrument
- •patients who previously used CES therapy
结局指标
主要结局
Mean Post-Traumatic Stress Questionnaire-Military (PCL-M) Score
时间窗: Baseline, Week 4, Week 8
Subjects were asked to complete questionnaire three times during the course of study. Questions addressed symptoms associated with Post Traumatic Stress Disorder(PTSD). Scores can range from 17 to 85. A score \>31 was used to identify symptomatic subjects and was therefore required at baseline for study enrollment.
Mean Center for Epidemiological Studies-Depression Scale (CES-D) Score
时间窗: Baseline, 4 Weeks, 8 Weeks
This 20-item questionnaire measures depressive symptoms. Scores can range from 0-60, with scores greater than 16 indicating need for further evaluation due to possible Major Depression.
Mean Brief Profile of Mood States (BPOMS) Score
时间窗: Baseline, Week 4, Week 8
BPOMS is a tool used to qualitatively measure anxiety. Subjects were asked to evaluate 30 feelings that they may have had over the past week. Stress-associated feelings are scored on a 5-point Likert scale from 0 (not at all)to 4 (extremely). Six of the feelings listed on the questionnaire are not associated with anxiety and therefore are not scored. Total scores range from 0-96, with higher scores indicating greater tension and anxiety.
Mean Visual Analogue Scale of Pain (VAS-P) Before and After Cranial Electrotherapy Stimulation (CES).
时间窗: Blinded Period, Unblinded Period
Subjects were asked to evaluate their pain intensity before and after each daily CES or sham treatment. Responses were scored on a scale ranging from 0 (indicating no pain) to 10 (worst possible pain).
Mean Visual Analogue Scale of Anxiety (VAS-A) Before and After Cranial Electrotherapy Stimulation (CES).
时间窗: Blinded Period, Unblinded Period
Subjects were asked to evaluate their anxiety level before and after each daily CES treatment. Responses were scored on a scale ranging from 0 (indicating no anxiety) to 10 (worst possible).
Mean General Sleep Disturbance Scale (GSDS) Score
时间窗: Baseline, Week 4, Week 8
The GSDS is a questionnaire used to qualitatively evaluate sleep. This 21-question tool evaluates each aspect of sleep and restfulness on a 0-7 score, indicating the number of days per week that each problem may be present. Total scores range from 0-147, with higher scores indicating more profound disturbances in sleep.
次要结局
未报告次要终点