Acupuncture for Fibromyalgia
关键词
抽象
描述
A total of 158 volunteers of patients with fibromyalgia will be recruited from the Chinese medicine or Western medicine clinics in China Medical University Hospital(Taichung and other affiliated branches). After diagnosis by rheumatologist, these patients will be randomized to receive verum acupuncture or sham acupuncture treatment, three times a week, for 4 weeks (12 treatment in total). Visual analogue scale will be done for every visit. Laboratory biochemistric analysis and other questionnaires including Visual Analogue Scale, Fibromyalgia Impact Questionnaire, SF-36 health survey, Pittsburgh Sleep Quality Index and Beck Depression Inventory-II will be completed at baseline, 2, 4 weeks after initiation of intervention (complete acupuncture treatment), 4 weeks after completion of acupuncture completion (8 weeks). PET image examination (optional; this item depends on patients' own will) and instrumental examinations including heart rate variability and traditional Chinese medicine four examinations will be given before and after intervention. We expect that the efficacy of verum acupuncture is superior to sham acupuncture in improving pain, fatigue, physical function and quality of life. The effectiveness of acupuncture can be detected by questionnaires. Moreover, we will further speculate the mechanism by analyzing laboratory and image data.
日期
| 最后验证: | 09/30/2015 |
| 首次提交: | 06/06/2015 |
| 提交的预估入学人数: | 10/19/2015 |
| 首次发布: | 10/21/2015 |
| 上次提交的更新: | 10/19/2015 |
| 最近更新发布: | 10/21/2015 |
| 实际学习开始日期: | 12/31/2014 |
| 预计主要完成日期: | 12/31/2015 |
| 预计完成日期: | 03/31/2016 |
状况或疾病
干预/治疗
Device: Verum Acupuncture
Device: Sham Acupuncture
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Verum Acupuncture After diagnosis by rheumatologist, participants will be randomized to receive verum acupuncture or sham acupuncture treatment. In the verum acupuncture group, participants will receive verum acupuncture (Device: 30# acupuncture needle) three times a week, for 4 weeks (12 treatment in total). | Device: Verum Acupuncture Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34) |
| Sham Comparator: Sham Acupuncture After diagnosis by rheumatologist, participants will be randomized to receive verum acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture (Device: Streitberger device) three times a week, for 4 weeks (12 treatment in total). | Device: Sham Acupuncture Streitberger device will be applied by onto acupoints (LI4, LI11, LR3, ST36, SP6, GB34). The device will not really insert the blunt needle into skin but let the participants feel like real acupuncture (Lancet 1998; 352: 364-365.). |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Participants met the diagnostic criteria (American College of Rheumatology, 2011) and were diagnosed fibromyalgia. 2. Persisted pain for more than 50 percent of time. 3. Adult volunteers of ages between 20~75 years old. 4. Male or female genders. 5. No allergy or contraindication to stainless needles. 6. Participants understood the aim and process of the trial, agreed to participate in trial as well as completed informed consent. Exclusion Criteria: 1. More than 75 or less than 20 years old. 2. Had used opioid or narcotic analgesic drugs within one month before the beginning of trial. 3. Had used Pregabalin within 6 months. 4. Drug abuse. 5. Coagulation dysfunction or low platelet count in blood tests(platelet≤150000 / uL). 6. Other diagnosed rheumatoid comorbidities such as rheumatoid arthritis, systemic lupus erythema, inflammatory bowel disease, autoimmune thyroiditis. 7. Participating in other clinical trials. 8. Pregnancy or lactation. 9. Severe psychological or behavioral disorders such as schizophrenia. 10. Arrhythmia patients with pacer marker. 11. Severe diseases such as myocardial infarction, severe arrhythmia,cardiac arrest, chronic obstructive pulmonary disease, renal failure and cancers. 12. Limbs edema and severe skin lesions contraindicated to acupuncture. 13. Had Chinese medicine or acupuncture within two weeks prior to the beginning of trial. 14. Had not completed informed consent. |
结果
主要结果指标
1. Fibromyalgia Impact Questionnaire [0,2,4,8 week]
次要成果指标
1. SF-36 health survey [0,2,4,8 week]
2. Pittsburgh Sleep Quality Index [0,2,4,8 week]
3. Beck Depression Inventory-II [0,2,4,8 week]
4. The Constitution in Chinese Medicine Questionnaire [0,2,4,8 week]
5. Heart rate variability [0,4 week]
6. Laboratory examination: cytokines [0,4 week]
7. Hematogram [0,4 week]
8. FDG PET/CT scan [0, 4-6week]
9. Visual Analogue Scale [0,2,4,8 week]
10. TCM four examinations [0,4 week]
11. Liver function test [0,4 week]
12. Renal function test [0,4 week]
13. Widespread pain index [0,2,4,8 week]
14. Symptom severity scale [0,2,4,8 week]
