Acupuncture and Pain Processing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale
研究概览
简要总结
The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.
详细描述
Patients and healthy controls will be enrolled in the study for a total of 6 weeks. This includes a screening and baseline visit, 8 acupuncture treatments (2 per week for 4 weeks), and a follow-up visit and treatment 1 week after completion of the study treatment sessions. To determine the effects of acupuncture on pain, patients and healthy controls will undergo psychophysical pain testing at four points throughout the study: Baseline (appointment 1), post-treatment 1 (appointment2), post treatment 8 (appointment 9), and at the final follow-up session (1 week from last treatment - appointment 10).Participants will also fill out a brief report on pain, sleep, and functioning on a palm pilot. This is expected to take less than 2 minutes per day and will occur throughout the 6 week study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fibromyalgia patient OR healthy control
- •No current opioid use
- •Patients: must have had Fibromyalgia for 6 months or longer
排除标准
- •Inflammatory disorder (lupus, rheumatoid arthritis)
- •Current untreated depression
- •Active infection
- •Healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study
- •Heart disease or use of a cardiac pacemaker
结局指标
主要结局
Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale
时间窗: Measured at last study acupuncture session (6 weeks post enrollment)
次要结局
- Change in Fibromyalgia Impact Questionnaire(Change from first to last study treatment session (6 weeks))
- Change in Brief Pain Inventory(Change from first to last treatment session (6 weeks))
研究者
Sean Mackey
Assistant Professor
Stanford University