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Fibromyalgia Acupuncture Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00882271
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : November 18, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Fibromyalgia Other: Acupuncture

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia
Study Start Date : January 2008
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Health/Activity Questionnaire [ Time Frame: Baseline ]
  2. The Fibromyalgia Impact Questionnaire [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ]
  3. Multidimensional Pain Inventory [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ]
  4. Beck Depression Inventory [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ]

Secondary Outcome Measures :
  1. 30-sec Chair Stand [ Time Frame: Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011

Keywords provided by Sivarama Vinjamury, 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