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Fibromyalgia Acupuncture Study
This study is currently recruiting participants.
Verified by Southern California University of Health Sciences, September 2009
First Received: April 14, 2009   Last Updated: September 24, 2009   History of Changes
Sponsor: Southern California University of Health Sciences
Information provided by: Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT00882271
  Purpose

The acupuncture treatment in this study is particularly aimed at reducing the pain and other negative health events such as emotional trauma and disability associated with Fibromyalgia, while improving the quality of life and promoting general health.


Condition Intervention
Fibromyalgia
Other: Acupuncture

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Southern California University of Health Sciences:

Primary Outcome Measures:
  • Health/Activity Questionnaire [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • The Fibromyalgia Impact Questionnaire [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ] [ Designated as safety issue: No ]
  • Multidimensional Pain Inventory [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-sec Chair Stand [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Traditional Chinese Acupuncture
Other: Acupuncture
Ten Acupuncture treatments within six weeks
2: Placebo Comparator
Placebo Acupuncture
Other: Acupuncture
Ten Acupuncture treatments within six weeks

Detailed Description:

It is hypothesized that acupuncture treatment will be effective in reducing pain and improving lower body strength and overall functionality more than the sham acupuncture treatment in people with Fibromyalgia (FM). The purpose of this study is to compare the efficacy of acupuncture with simulated acupuncture in patients with FM using a randomized controlled design. More specifically, the objectives of this study are to determine if acupuncture can (1) reduce pain, (2) improve lower body strength, and (3) improve overall functionality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must be 18 years or older and can be of either sex.
  2. A confirmed diagnosis of FM (pain for more than three months) will be required to participate in the study. If they do not have a diagnosis the study clinician or research assistant will examine them and determine their eligibility.
  3. All participants must be willing to provide a written informed consent prior to participation and should not have undergone acupuncture treatment in the past.

Exclusion Criteria:

  1. Acupuncture treatment in the past five years.
  2. Unwilling to sign informed consent.
  3. Less than a score of 40 on the Fibromyalgia Impact Questionnaire,
  4. Involvement in any litigation currently or in the past,
  5. Simultaneous infection with HIV/Hepatitis B virus.
  6. Severe depression (Beck depression score >21),
  7. History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  8. Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical conditions (including unstable hypertension, hypo or hyperthyroidism, or psychological conditions that in the opinion of the investigators would compromise participation or be likely to lead to an adverse response, including injuries or hospitalization, during the course of the study. We will get the information from the health/activity questionnaire.
  9. Have any DSM-IV Axis (major depression, addiction, anxiety) disorder which, in the judgment of the investigators, would interfere with compliance with the study protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882271

Contacts
Contact: Sivarama P Vinjamury, MD, MAOM 562-947-8755 ext 7364 sivaramavinjamury@scuhs.edu

Locations
United States, California
Southern California University of Health Sciences Recruiting
Whittier, California, United States, 90604
Contact: Sivarama P Vinjamury, MD, MAOM     562-947-8755 ext 7364     sivaramavinjamury@scuhs.edu    
Contact: Lung Sheng Hsiao, MSOM     562-947-8755 ext 608     lungshenghsiao@scuhs.edu    
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
Principal Investigator: Sivarama P Vinjamury, MD, MAOM Southern California University of Health Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Southern California University of Health Sciences ( Sivarama P.Vinjamury )
Study ID Numbers: SCU-08-VINJ003
Study First Received: April 14, 2009
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00882271     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California University of Health Sciences:
Fibromyalgia
Acupuncture
Pain

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

ClinicalTrials.gov processed this record on February 08, 2010