FibromyalgiaNCT02583334
Acupuncture for Fibromyalgia
A study testing Verum acupuncture (30# acupuncture needle) in people with Fibromyalgia, run by China Medical University Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Verum acupuncture (30# acupuncture needle)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Hung-Rong Yen, M.D., Ph.D., 886-4-22052121 ext. 7508, hungrongyen@gmail.com
Ming-Cheng Huang, M.D., 886-4-22052121 ext. 1670, mchuang1128@gmail.com
- Recruiting
China Medical University Hospital-Taipei branch
Taipei, 114
Hung-Rong Yen, M.D., Ph.D., +886-4-22052121 ext. 7508, hungrongyen@gmail.com
Hung-Rong Yen, M.D., Ph.D.
About this study
Official title: Clinical Efficacy of Acupuncture in Patients With Fibromyalgia: A Multi-center, Randomized, Assessor and Participant-blinded, Controlled, and Parallel-design Clinical Trial
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Verum acupuncture (30# acupuncture needle), Sham acupuncture
- Keywords
- acupuncture, fibromyalgia, rheumatism, clinical trial
- Medical subject headings
- Fibromyalgia, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum acupuncture (30# acupuncture needle)Device
Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)
Sham acupunctureDevice
Also called Streitberger device
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.).
| Study group | Role | What they receive |
|---|---|---|
| Verum Acupuncture | Experimental | 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). Receives: Device: Verum acupuncture (30# acupuncture needle) |
| Sham Acupuncture | Sham comparator | 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). Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Measured: 0,2,4,8 week
Secondary outcomes (14)
SF-36 health survey
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Measured: 0,2,4,8 week
Pittsburgh Sleep Quality Index
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Measured: 0,2,4,8 week
Beck Depression Inventory-II
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Measured: 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
Measured: 0,2,4,8 week
Heart rate variability
Changes from baseline to the end of intervention
Measured: 0,4 week
Laboratory examination: cytokines
Changes from baseline to the end of intervention
Measured: 0,4 week
Hematogram
Changes from baseline to the end of intervention
Measured: 0,4 week
FDG PET/CT scan
optional examination; changes from baseline to the 4-6week of intervention
Measured: 0, 4-6week
Visual Analogue Scale
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Measured: 0,2,4,8 week
TCM four examinations
Changes from baseline to the end of intervention
Measured: 0,4 week
Liver function test
Changes at baseline and end of intervention
Measured: 0,4 week
Renal function test
Changes from baseline to the end of intervention
Measured: 0,4 week
Widespread pain index
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Measured: 0,2,4,8 week
Symptom severity scale
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Measured: 0,2,4,8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Rong Yen, M.D., Ph.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583334
- Sponsor's protocol ID
- CMUH103-REC1-138
- Status last verified
- Oct 2015
- First submitted
- 7 Jun 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Acupuncture in Patients With Fibromyalgia: A Multi-center, Randomized, Assessor and Participant-blinded, Controlled, and Parallel-design Clinical Trial
- ClinicalTrials.gov ID
- NCT02583334
- Acronym / sponsor ID
- CMUH103-REC1-138
- Conditions
- Fibromyalgia
- Keywords
- acupuncture, fibromyalgia, rheumatism, clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Acupuncture | Experimental | Device: Verum acupuncture (30# acupuncture needle)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). |
| Sham Acupuncture | Sham comparator | Device: Sham acupunctureAfter 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). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum acupuncture (30# acupuncture needle)Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34) | Device | Verum Acupuncture |
| Sham acupunctureAlso: Streitberger deviceStreitberger 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.). | Device | Sham Acupuncture |
Primary outcome
Fibromyalgia Impact Questionnaire
Time frame: 0,2,4,8 week
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
14 secondary outcomes
SF-36 health survey
Time frame: 0,2,4,8 week
Pittsburgh Sleep Quality Index
Time frame: 0,2,4,8 week
Beck Depression Inventory-II
Time frame: 0,2,4,8 week
The Constitution in Chinese Medicine Questionnaire
Time frame: 0,2,4,8 week
Heart rate variability
Time frame: 0,4 week
Laboratory examination: cytokines
Time frame: 0,4 week
Hematogram
Time frame: 0,4 week
FDG PET/CT scan
Time frame: 0, 4-6week
Visual Analogue Scale
Time frame: 0,2,4,8 week
TCM four examinations
Time frame: 0,4 week
Liver function test
Time frame: 0,4 week
Renal function test
Time frame: 0,4 week
Widespread pain index
Time frame: 0,2,4,8 week
Symptom severity scale
Time frame: 0,2,4,8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Rong Yen, M.D., Ph.D. principal investigator
China Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum acupuncture (30# acupuncture needle) in people with Fibromyalgia, run by China Medical University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Rong Yen, M.D., Ph.D. (+886-4-22052121 ext. 7508, hungrongyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnaire (time frame: 0,2,4,8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.