A Randomized Clinical Trial Utilizing Battlefield Acupuncture to Treat Chronic Pain in Veterans With a History of Substance Use Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Acupuncture questionnaire evaluating chronic pain levels
研究概览
简要总结
This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on veterans with with a history of substance use disorder and chronic pain for 8 weeks.
Primary Aim: The primary aim of this study is to evaluate the effectiveness of using BFA to treat chronic pain in veterans with a history of substance use disorder.
Secondary Aim: This study will also evaluate the impact that BFA treatment for pain may have on subjects' stress, mood and sleep patterns over 8 weeks. In addition, each subject will be complete behavioral research tools to measure: depression, anxiety, and substance use at 3 different points in this study.
Hypothesis: The use of BFA on veterans with chronic pain will decrease their pain and substance use and improve their quality of life.
详细描述
Objective(s): This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on veterans with with a history of substance use disorder and chronic pain for 8 weeks.
Primary Aim: The primary aim of this study is to evaluate the effectiveness of using BFA to treat chronic pain in veterans with a history of substance use disorder.
Secondary Aim: This study will also evaluate the impact that BFA treatment for pain may have on subjects' stress, mood and sleep patterns over 8 weeks. In addition, each subject will be complete behavioral research tools to measure: depression, anxiety, and substance use at 3 different points in this study.
Hypothesis: The use of BFA on veterans with chronic pain will decrease their pain and substance use and improve their quality of life.
2. Research Design: This is a prospective, RCT trial research study recruiting veterans with a history of chronic pain and substance use disorder.
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
- None
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
- •Eligibility criteria include:
- •they are 18 years or older
- •they have a history of substance use disorder,
- •history of chronic pain
- •availability to participate in the study for 16 weeks.
排除标准
- •female veterans who are pregnant.
- •history of bleeding disorders or currently on older blood thinning medications that cause excessive bleeding.
- •currently being treated for an active infection of the outer ear (relative contraindication). -- currently have a PICC line in their body or are receiving IV antibiotics.
- •fear of needles/tacks, and/or
- •undiagnosed pain complaint
结局指标
主要结局
Acupuncture questionnaire evaluating chronic pain levels
时间窗: 8 weeks of treatment, 8 weeks of post treatment follow-up
Chronic pain level questionnaire ( Acupuncture questionnaire consists of X questions regarding pain. Patients select the level of pain from 0-10 ( the higher the number, the higher the pain. The scale range would be = (0-60).
次要结局
- Acupuncture Follow up Questionnaire which also evaluates the impact that BFA treatment for pain may have on subjects' stress, mood and sleep patterns over 8 weeks.(8 weeks of treatment and 8 weeks of follow up)
- PHQ-4(monthly for 16 weeks)
- Substance Use Questionnaire-(monthly for 16 weeks)
研究者
Cathy St. Pierre
Principal Investigator
Edith Nourse Rogers Memorial Veterans Hospital