Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Health/Activity Questionnaire
研究概览
简要总结
The acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with Fibromyalgia, while improving the quality of life and promoting general health.
详细描述
It is hypothesized that acupuncture treatment will be effective in reducing pain and improving lower body strength and overall functionality more than the sham acupuncture treatment in people with Fibromyalgia (FM). The purpose of this study is to compare the efficacy of acupuncture with simulated acupuncture in patients with FM using a randomized controlled design. More specifically, the objectives of this study are to determine if acupuncture can (1) reduce pain, (2) improve lower body strength, and (3) improve overall functionality.
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
- Single (Participant)
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
- •Participants must be 18 years or older and can be of either sex.
- •A confirmed diagnosis of FM (pain for more than three months) will be required to participate in the study. If they do not have a diagnosis the study clinician or research assistant will examine them and determine their eligibility.
- •All participants must be willing to provide a written informed consent prior to participation and should not have undergone acupuncture treatment in the past.
排除标准
- •Acupuncture treatment in the past five years.
- •Unwilling to sign informed consent.
- •Less than a score of 40 on the Fibromyalgia Impact Questionnaire,
- •Involvement in any litigation currently or in the past,
- •Simultaneous infection with HIV/Hepatitis B virus.
- •Severe depression (Beck depression score >21),
- •History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- •Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical conditions (including unstable hypertension, hypo or hyperthyroidism, or psychological conditions that in the opinion of the investigators would compromise participation or be likely to lead to an adverse response, including injuries or hospitalization, during the course of the study. We will get the information from the health/activity questionnaire.
- •Have any DSM-IV Axis (major depression, addiction, anxiety) disorder which, in the judgment of the investigators, would interfere with compliance with the study protocol.
研究组 & 干预措施
1
Traditional Chinese Acupuncture
干预措施: Acupuncture (Other)
2
Placebo Acupuncture
干预措施: Acupuncture (Other)
结局指标
主要结局
Health/Activity Questionnaire
时间窗: Baseline
The Fibromyalgia Impact Questionnaire
时间窗: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Multidimensional Pain Inventory
时间窗: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
Beck Depression Inventory
时间窗: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
次要结局
- 30-sec Chair Stand(Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months)
研究者
Sivarama Vinjamury
Fibromyalgia Acupuncture Study
Southern California University of Health Sciences