A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Change from Baseline in Headache Impact Test at Week 6
研究概览
简要总结
This study investigates whether acupuncture can help to decrease the number and severity of headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two different types of acupuncture-either Traditional Chinese Acupuncture or ear acupuncture-to a group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce pain, improve health-related quality of life, prevent migraine headaches, and improve tension and chronic daily headaches.
详细描述
This is a 12 week study. If eligible, participants will be randomly assigned to 1of 3 groups: ear acupuncture, Traditional Chinese Acupuncture, or the usual care group.
Subjects receiving acupuncture will:
- meet with one of the acupuncturists who will conduct her first assessment
- come to Walter Reed Army Medical Center (WRAMC) 10 times over a 6-week period to receive acupuncture treatments from a licensed acupuncturist
Subjects in the usual care group will:
- not receive any acupuncture treatments
- continue usual treatment plan
- be given the option to receive 10 acupuncture treatments between the 6- and 12-week period
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
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-69 years of age
- •Service Members with previous deployment to war zone
- •Non-acute mild to moderate traumatic brain injury as defined by:
- •Injury event (i.e., blast, fall, MVC, head impact) that occurred at least 7 days prior
- •Loss of consciousness (if present) for less than 24 hours and alteration of consciousness or posttraumatic amnesia for less than one week
- •Presence of headache or any etiology requiring self-medication or medical management with at least 4 headache days in the past 4 weeks
- •Rancho Los Amigos Cognitive Scale score of greater than or equal to 7
- •Able to provide informed consent
排除标准
- •Acupuncture treatment for any reason within the past month
- •Any active unstable psychiatric condition, including active psychosis, suicidal or homicidal ideation
- •Unwillingness on the part of the participant to complete all study visits and/or components of the intervention
- •Scheduled surgery during the treatment phase of the study
- •Pregnancy or breastfeeding at time of study enrollment or during study participation
- •Any medically unstable condition that in the opinion of the P.I. has the potential to warrant inpatient treatment in the medical or intensive care units
- •Inability to give informed consent or complete study measures
结局指标
主要结局
Change from Baseline in Headache Impact Test at Week 6
时间窗: Baseline, Week 6, Week 12
This is a 6-item measure that assesses headache severity. This will take approximately 1 minute to complete.
次要结局
- Daily Headache Diary(Completed daily for 6 weeks)
- Change from Baseline in Numerical Rating Scale at Week 6(Baseline, Week 6)
- Change from Baseline in Symptom Checklist 90-R at Week 6(Baseline, Week 6)
- Change from Baseline in State-Trait Anxiety Inventory at Week 6(Baseline, Week 6)
- Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6(Baseline, Week 6)
- Change from Baseline in Expectancy Scale at Week 6(Baseline, Week 6)
- Change from Baseline in Beck Depression Inventory at Week 6(Baseline, Week 6)
- Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6(Baseline, Week 6)
- Change from Baseline in Medical Outcome Study Quality of Life at Week 6(Baseline, Week 6)
- Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6(Baseline, Week 6)