Acupuncture for Fibromyalgia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Efficacy of Acupuncture in Patients With Fibromyalgia: A Multi-center, Randomized, Assessor and Participant-blinded, Controlled, and Parallel-design Clinical Trial

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Verum acupuncture (30# acupuncture needle)
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants met the diagnostic criteria (American College of Rheumatology, 2011) and were diagnosed fibromyalgia. Persisted pain for more than 50 percent of time. Adult volunteers of ages between 20 75 years old. Male or female genders. No allergy or contraindication to stainless needles. Participants understood the aim and process of the trial, agreed to participate in trial as well as completed informed consent. Exclusion Criteria: More than 75 or less than 20 years old. Had used opioid or narcotic analgesic drugs within one month before the beginning of trial. Had used Pregabalin within 6 months. Drug abuse. Coagulation dysfunction or low platelet count in blood tests(platelet≤150000 / uL). Other diagnosed rheumatoid comorbidities such as rheumatoid arthritis, systemic lupus erythema, inflammatory bowel disease, autoimmune thyroiditis. Participating in other clinical trials. Pregnancy or lactation. Severe psychological or behavioral disorders such as schizophrenia. Arrhythmia patients with pacer marker. Severe diseases such as myocardial infarction, severe arrhythmia,cardiac arrest, chronic obstructive pulmonary disease, renal failure and cancers. Limbs edema and severe skin lesions contraindicated to acupuncture. Had Chinese medicine or acupuncture within two weeks prior to the beginning of trial. Had not completed informed consent.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum Acupuncture<br>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 (30# acupuncture needle)<br>* Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)<br>|
| Sham Comparator: Sham Acupuncture<br>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<br>* 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.).<br>* Other names: Streitberger device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 health survey | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 
| Pittsburgh Sleep Quality Index | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 
| Beck Depression Inventory-II | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 
| The Constitution in Chinese Medicine Questionnaire | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 
| Heart rate variability | Changes from baseline to the end of intervention | 0,4 week | 
| Laboratory examination: cytokines | Changes from baseline to the end of intervention | 0,4 week | 
| Hematogram | Changes from baseline to the end of intervention | 0,4 week | 
| FDG PET/CT scan | optional examination; changes from baseline to the 4-6week of intervention | 0, 4-6week | 
| Visual Analogue Scale | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 
| TCM four examinations | Changes from baseline to the end of intervention | 0,4 week | 
| Liver function test | Changes at baseline and end of intervention | 0,4 week | 
| Renal function test | Changes from baseline to the end of intervention | 0,4 week | 
| Widespread pain index | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 
| Symptom severity scale | Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed | 0,2,4,8 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, fibromyalgia, rheumatism, clinical trial