Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Gut Microbiota and Brain Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change of Tender Point Count (TPC) from baseline
研究概览
简要总结
To investigate the mechanism by Ba-Duan-Jin in the treatment of fibromyalgia. Twenty eligible fibromyalgia patients were selected, and were trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. The evaluation points were 0, 4, 8, and 12 weeks. The change of pain Visual Analogue Score (VAS) and tener point count (TPC) post-treatment were evaluated. And blood, feces, and brain fMRI were collected from the patients at 0 and 12 weeks to compare the changes in gut microbiota, metabolites, and brain function networks before and after the intervention with the 16SrRNA sequencing, targeted metabolomics, and real-time Quantitative Polymerase Chain Reaction (PCR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia or 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
- •Be over 18 years of age;
- •Right-handedness;
- •Sign informed consent.
排除标准
- •be less than 40mm of pain VAS score;
- •had received any treatments for fibromyalgia or probiotic bacteria within 2 weeks;
- •had received antibiotics within 4 weeks;
- •had practiced Ba-Duan-Jin, Tai Chi, yoga, or other forms of Qigong within previous 12 months;
- •had severe depression or anxiety;
- •pregnancy or planned pregnancy within the study period;
- •had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
- •patients with a history of head trauma, cerebral infarction or cerebral haemorrhage
- •contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
结局指标
主要结局
The change of Tender Point Count (TPC) from baseline
时间窗: Baseline, week4, week8, week12
TPC, the 18 body points of the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia, which in healthy subjects do not cause pain, whereas in patients with fibromyalgia no fewer than 11 are painful
The change of the Visual Analogue Scale (VAS) for pain from baseline
时间窗: Baseline, week4, week8, week12
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain
次要结局
- Brain morphology in fibromyalgia patients measured by structural MRI(Baseline, week12)
- The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline(Baseline, week4, week8, week12)
- Serum fatty acids metabolism results by UPLC-MS/MS(Baseline, week12)
- The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline(Baseline, week4, week8, week12)
- Brain functional connectivity in fibromyalgia patients measured by function MRI(Baseline, week12)
- Gut microbiota sequencing results by analyzing metagenomes of microbial genes(Baseline, week12)
研究者
Juan Jiao
Chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences