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Fibromyalgia Acupuncture Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sivarama Vinjamury, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00882271
First received: April 14, 2009
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Traditional Chinese Acupuncture
 Other: Acupuncture
Ten Acupuncture treatments within six weeks
Placebo Comparator: 2
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

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:
Visit Southern California University of Health Sciences Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sivarama Vinjamury, Fibromyalgia Acupuncture Study, Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT00882271     History of Changes
Other Study ID Numbers: SCU-08-VINJ003
Study First Received: April 14, 2009
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board

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

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 June 18, 2013