Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change of the Visual Analogue Scale (VAS) for pain from baseline.
研究概览
简要总结
Fibromyalgia (FM) is a chronic debilitating musculoskeletal pain syndrome. "Central sensitization" is an important mechanism of the disease. Recent studies have shown that "microbiome-gut-brain axis" imbalance may be one of the important mechanisms of "central sensitization". The purpose of this study was to investigate the therapeutic mechanism of Ba-Duan-Jin therapy in the treatment of fibromyalgia by improving intestinal microecology. The mechanism was evaluated by comparing the results of brain functional MRI (fMRI) and microbacterial analysis of the patients' stool pre and post treatment .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（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 and 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
- •be between the ages of 18 to 70 years;
- •not taking medication for FM for at least 4 weeks;
- •no special eating habits.
排除标准
- •had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
- •be less than 40mm of pain VAS score;
- •had renal failure, severe depression or anxiety;
- •had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
- •pregnancy or planned pregnancy within the study period;
- •patients residing more than 70 miles from the research site;
- •patients with a history of head trauma;
- •a smoker or drinker;
- •contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
- •patients with cerebral infarction or cerebral hemorrhage.
研究组 & 干预措施
Ba-Duan-Jin group
The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital; Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks.
干预措施: Ba-Duan-Jin (Behavioral)
Pregabalin group
Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise.
Active pregabalin capsules: As same usage as the placebo pregabalin capsules.
干预措施: Pregabalin capsule (Drug)
结局指标
主要结局
The change of the Visual Analogue Scale (VAS) for pain from baseline.
时间窗: Baseline, week4, week8, week12, week24
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain.
次要结局
- Gut microbiota sequencing results by analyzing metagenomes of microbial genes(Baseline, week12)
- Serum Brain Derived Neurotrophic Factor (BDNF) levels(Baseline, week12)
- The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.(Baseline, week 4, week 8, and week 12.)
- Global Impression of Change (PGIC) questionnaire evaluated at week 12.(Week 12.)
- fMRI of the brain in patients with fibromyalgia(Baseline, week12)
- Serum Tyrosine kinase B (TrkB) levels(Baseline, week12)
研究者
Juan Jiao
Deputy chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences