Fibromyalgia
Conditions
Keywords
acupuncture, fibromyalgia, rheumatism, clinical trial
Brief summary
Fibromyalgia is the second most common autoimmune rheumatic diseases with clinical manifestations of widespread pain, fatigue and accompanied cognitive and emotional disturbances. It often associated with sleep disorders and headaches. The cardinal symptom of fibromyalgia is widespread pain. Clinical observations reveal that pain in patients with fibromyalgia could not simply improve by using analgesics only. Patients often use Chinese medicine or acupuncture to help them to ease the pain. The aim of this study is to investigate the efficacy of acupuncture in patients with fibromyalgia. The study adapted a randomized, assessor- and participant-blinded, sham-controlled, and parallel-design approach to investigate whether acupuncture can improve the clinical symptoms and quality of life as well as the mechanism through laboratory biochemistric and image study.
Detailed description
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.
Interventions
DEVICEVerum acupuncture (30# acupuncture needle)
Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)
DEVICESham 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.).
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Impact Questionnaire | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Widespread pain index | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
| Symptom severity scale | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
| SF-36 health survey | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
| Pittsburgh Sleep Quality Index | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
| Beck Depression Inventory-II | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
| The Constitution in Chinese Medicine Questionnaire | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
| Renal function test | 0,4 week | Changes from baseline to the end of intervention |
| Laboratory examination: cytokines | 0,4 week | Changes from baseline to the end of intervention |
| Hematogram | 0,4 week | Changes from baseline to the end of intervention |
| FDG PET/CT scan | 0, 4-6week | optional examination; changes from baseline to the 4-6week of intervention |
| Visual Analogue Scale | 0,2,4,8 week | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed |
| TCM four examinations | 0,4 week | Changes from baseline to the end of intervention |
| Liver function test | 0,4 week | Changes at baseline and end of intervention |
| Heart rate variability | 0,4 week | Changes from baseline to the end of intervention |
Countries
Taiwan
Contacts
Primary ContactHung-Rong Yen, M.D., Ph.D.
Backup ContactMing-Cheng Huang, M.D.
Outcome results
None listed