Acupuncture for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Clinical Efficacy of Acupuncture in Patients With Fibromyalgia: A Multi-center, Randomized, Assessor and Participant-blinded, Controlled, and Parallel-design Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583334
• Other study ID #: CMUH103-REC1-138
• Status: Recruiting
• Phase: N/A
• First received: June 7, 2015
• Last updated: October 20, 2015
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2015
• Source: China Medical University Hospital
• Contact: Hung-Rong Yen, M.D., Ph.D.
• Phone: +886-4-22052121
• Email: hungrongyen[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• Verum acupuncture (30# acupuncture needle)
Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)
• 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.).

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung
Taiwan	China Medical University Hospital-Taipei branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No
Secondary	SF-36 health survey	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No
Secondary	Pittsburgh Sleep Quality Index	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No
Secondary	Beck Depression Inventory-II	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No
Secondary	The Constitution in Chinese Medicine Questionnaire	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No
Secondary	Heart rate variability	Changes from baseline to the end of intervention	0,4 week	No
Secondary	Laboratory examination: cytokines	Changes from baseline to the end of intervention	0,4 week	No
Secondary	Hematogram	Changes from baseline to the end of intervention	0,4 week	Yes
Secondary	FDG PET/CT scan	optional examination; changes from baseline to the 4-6week of intervention	0, 4-6week	No
Secondary	Visual Analogue Scale	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No
Secondary	TCM four examinations	Changes from baseline to the end of intervention	0,4 week	No
Secondary	Liver function test	Changes at baseline and end of intervention	0,4 week	Yes
Secondary	Renal function test	Changes from baseline to the end of intervention	0,4 week	Yes
Secondary	Widespread pain index	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No
Secondary	Symptom severity scale	Changes from baseline to midpoint?end of intervention and 4 weeks after intervention completed	0,2,4,8 week	No