Back to resultsAcupuncture for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Verum acupuncture (30# acupuncture needle)
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring acupuncture, fibromyalgia, rheumatism, clinical trial
Eligibility Criteria
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.
Sites / Locations
- China Medical University HospitalRecruiting
- China Medical University Hospital-Taipei branchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Verum Acupuncture
Sham Acupuncture
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnaire
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Secondary Outcome Measures
SF-36 health survey
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Pittsburgh Sleep Quality Index
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Beck Depression Inventory-II
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
The Constitution in Chinese Medicine Questionnaire
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Heart rate variability
Changes from baseline to the end of intervention
Laboratory examination: cytokines
Changes from baseline to the end of intervention
Hematogram
Changes from baseline to the end of intervention
FDG PET/CT scan
optional examination; changes from baseline to the 4-6week of intervention
Visual Analogue Scale
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
TCM four examinations
Changes from baseline to the end of intervention
Liver function test
Changes at baseline and end of intervention
Renal function test
Changes from baseline to the end of intervention
Widespread pain index
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Symptom severity scale
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Full Information
NCT ID
NCT02583334
First Posted
June 7, 2015
Last Updated
October 20, 2015
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02583334
Brief Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
acupuncture, fibromyalgia, rheumatism, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum Acupuncture
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Verum acupuncture (30# acupuncture needle)
Intervention Description
Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Other Intervention Name(s)
Streitberger device
Intervention Description
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.).
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
Secondary Outcome Measure Information:
Title
SF-36 health survey
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
Title
Pittsburgh Sleep Quality Index
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
Title
Beck Depression Inventory-II
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
Title
The Constitution in Chinese Medicine Questionnaire
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
Title
Heart rate variability
Description
Changes from baseline to the end of intervention
Time Frame
0,4 week
Title
Laboratory examination: cytokines
Description
Changes from baseline to the end of intervention
Time Frame
0,4 week
Title
Hematogram
Description
Changes from baseline to the end of intervention
Time Frame
0,4 week
Title
FDG PET/CT scan
Description
optional examination; changes from baseline to the 4-6week of intervention
Time Frame
0, 4-6week
Title
Visual Analogue Scale
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
Title
TCM four examinations
Description
Changes from baseline to the end of intervention
Time Frame
0,4 week
Title
Liver function test
Description
Changes at baseline and end of intervention
Time Frame
0,4 week
Title
Renal function test
Description
Changes from baseline to the end of intervention
Time Frame
0,4 week
Title
Widespread pain index
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
Title
Symptom severity scale
Description
Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed
Time Frame
0,2,4,8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Rong Yen, M.D., Ph.D.
Phone
+886-4-22052121
Ext
7508
Email
hungrongyen@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Cheng Huang, M.D.
Phone
+886-4-22052121
Ext
1670
Email
mchuang1128@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D., Ph.D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D., Ph.D.
Phone
886-4-22052121
Ext
7508
Email
hungrongyen@gmail.com
First Name & Middle Initial & Last Name & Degree
Ming-Cheng Huang, M.D.
Phone
886-4-22052121
Ext
1670
Email
mchuang1128@gmail.com
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D., Ph.D.
Facility Name
China Medical University Hospital-Taipei branch
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D., Ph.D.
Phone
+886-4-22052121
Ext
7508
Email
hungrongyen@gmail.com
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Fibromyalgia
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