Clinical trial NCT02583334: Acupuncture for Fibromyalgia
Official title: Clinical Efficacy of Acupuncture in Patients With Fibromyalgia: A Multi-center, Randomized, Assessor and Participant-blinded, Controlled, and Parallel-design Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: acupuncture
fibromyalgia
rheumatism
clinical trial
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 158
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 0,2,4,8 week
Secondary outcomes:
measure: SF-36 health survey
timeFrame: 0,2,4,8 week
measure: Pittsburgh Sleep Quality Index
timeFrame: 0,2,4,8 week
measure: Beck Depression Inventory-II
timeFrame: 0,2,4,8 week
measure: The Constitution in Chinese Medicine Questionnaire
timeFrame: 0,2,4,8 week
measure: Heart rate variability
timeFrame: 0,4 week
measure: Laboratory examination: cytokines
timeFrame: 0,4 week
measure: Hematogram
timeFrame: 0,4 week
measure: FDG PET/CT scan
timeFrame: 0, 4-6week
measure: Visual Analogue Scale
timeFrame: 0,2,4,8 week
measure: TCM four examinations
timeFrame: 0,4 week
measure: Liver function test
timeFrame: 0,4 week
measure: Renal function test
timeFrame: 0,4 week
measure: Widespread pain index
timeFrame: 0,2,4,8 week
measure: Symptom severity scale
timeFrame: 0,2,4,8 week
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: China Medical University Hospital-Taipei branch
Study officials:
affiliation: China Medical University Hospital
name: Hung-Rong Yen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: