Acupuncture for Fibromyalgia
Clinical Efficacy of Acupuncture in Patients With Fibromyalgia: A Multi-center, Randomized, Assessor and Participant-blinded, Controlled, and Parallel-design Clinical Trial
1 other identifier
interventional
158
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 7, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedOctober 22, 2015
October 1, 2015
1 year
June 7, 2015
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fibromyalgia Impact Questionnaire
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
0,2,4,8 week
Secondary Outcomes (14)
SF-36 health survey
0,2,4,8 week
Pittsburgh Sleep Quality Index
0,2,4,8 week
Beck Depression Inventory-II
0,2,4,8 week
The Constitution in Chinese Medicine Questionnaire
0,2,4,8 week
Heart rate variability
0,4 week
- +9 more secondary outcomes
Study Arms (2)
Verum Acupuncture
EXPERIMENTALAfter 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).
Sham Acupuncture
SHAM COMPARATORAfter 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).
Interventions
Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)
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.).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
China Medical University Hospital
Taichung, 404, Taiwan
China Medical University Hospital-Taipei branch
Taipei, 114, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung-Rong Yen, M.D., Ph.D.
China Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2015
First Posted
October 22, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2016
Study Completion
April 1, 2016
Last Updated
October 22, 2015
Record last verified: 2015-10