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Completed

NCT Number: NCT00882271

Fibromyalgia Acupuncture Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must be 18 years or older and can be of either sex.
  • 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.
  • 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

  • Acupuncture treatment in the past five years.
  • Unwilling to sign informed consent.
  • Less than a score of 40 on the Fibromyalgia Impact Questionnaire,
  • Involvement in any litigation currently or in the past,
  • Simultaneous infection with HIV/Hepatitis B virus.
  • Severe depression (Beck depression score >21),
  • History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
  • 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.
  • 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.

Treatment and study plan

Acupuncture

Other

Ten Acupuncture treatments within six weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Southern California University of Health Sciences

Other

Registry information

Official study title

Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2009
Registry last updated
Nov 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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