Acupuncture Combined With Mindfulness in the Context of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Questions Regarding Pain and Other Symptoms
研究概览
简要总结
This study aims to gather preliminary data regarding acupuncture and mindfulness in the treatment of chronic pain.
详细描述
Neither acupuncture nor mindfulness have been studied with respect to chronic pain in an outpatient integrative health (IH) oncology clinic in the USA. Likewise, the combination of acupuncture and mindfulness combined as not been studied. Given that both acupuncture and mindfulness have demonstrated some analgesic relief in an acute pain setting, each merit study for pain relief in an outpatient setting.
The investigators are evaluating the impact of two different acupuncture approaches for patients reporting chronic pain. Acupuncture will be provided by a Licensed Acupuncturist for patients reporting chronic pain. Participants will be randomized to one of two treatments - acupuncture as usual or acupuncture plus mindfulness.
The investigators will collect data regarding chronic pain, interoceptive awareness, emotion regulation, and acceptability. The study is open to participants with any etiology and any location of chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, 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
- •Patient is age 18 or older.
- •Patient is experiencing pain (rated ≥3 on a 0-10 scale) lasting for three or more months.
- •Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- •ONLY FOR THOSE WITH A DIAGNOSIS OF CANCER: ECOG status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, <50% in bed during the day).
排除标准
- •Patient has received 5 or more acupuncture treatments in the last 2 months.
结局指标
主要结局
Questions Regarding Pain and Other Symptoms
时间窗: 2 months
A questionnaire regarding pain as well as physical and mental awareness. A Likert scale 0-10 is used, where 0 is classified as "not at all" and 10 is classified "very much." Higher values are a worse outcome with questions 7-9 reverse scored.
次要结局
- State Multidimensional Assessment of Interoceptive Awareness-2(2 months)
- Acceptability Questions(1 day)
- Qualitative Inquiry(1 day)
- Qualitative Interoceptive Awareness and Emotional Regulation(1 day)
- Quantitative questions(1 day)
- State Difficulties in Emotion Regulation Scale(2 months)
- Sensation Manikin(2 months)
- Retrospective Chart Review(3 month)
- Nondual Awareness Dimensional Assessment(2 months)
- Acupuncture Questions(2 months)
研究者
Lisa J Taylor-Swanson
Assistant Professor
University of Utah