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Trial record 7 of 138 for:    fibromyalgia | Open Studies | Interventional Studies

Acupuncture for Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by China Medical University Hospital
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT02583334
First received: June 7, 2015
Last updated: October 20, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention
Fibromyalgia
Device: Verum acupuncture (30# acupuncture needle)
Device: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Acupuncture in Patients With Fibromyalgia: A Multi-center, Randomized, Assessor and Participant-blinded, Controlled, and Parallel-design Clinical Trial

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Fibromyalgia Impact Questionnaire [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed


Secondary Outcome Measures:
  • SF-36 health survey [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed

  • Pittsburgh Sleep Quality Index [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed

  • Beck Depression Inventory-II [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed

  • The Constitution in Chinese Medicine Questionnaire [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed

  • Heart rate variability [ Time Frame: 0,4 week ] [ Designated as safety issue: No ]
    Changes from baseline to the end of intervention

  • Laboratory examination: cytokines [ Time Frame: 0,4 week ] [ Designated as safety issue: No ]
    Changes from baseline to the end of intervention

  • Hematogram [ Time Frame: 0,4 week ] [ Designated as safety issue: Yes ]
    Changes from baseline to the end of intervention

  • FDG PET/CT scan [ Time Frame: 0, 4-6week ] [ Designated as safety issue: No ]
    optional examination; changes from baseline to the 4-6week of intervention

  • Visual Analogue Scale [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed

  • TCM four examinations [ Time Frame: 0,4 week ] [ Designated as safety issue: No ]
    Changes from baseline to the end of intervention

  • Liver function test [ Time Frame: 0,4 week ] [ Designated as safety issue: Yes ]
    Changes at baseline and end of intervention

  • Renal function test [ Time Frame: 0,4 week ] [ Designated as safety issue: Yes ]
    Changes from baseline to the end of intervention

  • Widespread pain index [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed

  • Symptom severity scale [ Time Frame: 0,2,4,8 week ] [ Designated as safety issue: No ]
    Changes from baseline to midpoint、end of intervention and 4 weeks after intervention completed


Estimated Enrollment: 158
Study Start Date: January 2015
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum Acupuncture
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)
Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)
Sham Comparator: Sham Acupuncture
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
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.).
Other Name: Streitberger device

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

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02583334

Contacts
Contact: Hung-Rong Yen, M.D., Ph.D. +886-4-22052121 ext 7508 hungrongyen@gmail.com
Contact: Ming-Cheng Huang, M.D. +886-4-22052121 ext 1670 mchuang1128@gmail.com

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Hung-Rong Yen, M.D., Ph.D.    886-4-22052121 ext 7508    hungrongyen@gmail.com   
Contact: Ming-Cheng Huang, M.D.    886-4-22052121 ext 1670    mchuang1128@gmail.com   
Principal Investigator: Hung-Rong Yen, M.D., Ph.D.         
China Medical University Hospital-Taipei branch Recruiting
Taipei, Taiwan, 114
Contact: Hung-Rong Yen, M.D., Ph.D.    +886-4-22052121 ext 7508    hungrongyen@gmail.com   
Principal Investigator: Hung-Rong Yen, M.D., Ph.D.         
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Hung-Rong Yen, M.D., Ph.D. China Medical University Hospital
  More Information

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02583334     History of Changes
Other Study ID Numbers: CMUH103-REC1-138 
Study First Received: June 7, 2015
Last Updated: October 20, 2015
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
acupuncture
fibromyalgia
rheumatism
clinical trial

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016