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Fibromyalgia Acupuncture Study

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Southern California University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Acupuncture, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Traditional Chinese Acupuncture

    Placebo Acupuncture

    Outcomes

    Primary Outcome Measures

    Health/Activity Questionnaire
    The Fibromyalgia Impact Questionnaire
    Multidimensional Pain Inventory
    Beck Depression Inventory

    Secondary Outcome Measures

    30-sec Chair Stand

    Full Information

    First Posted
    April 14, 2009
    Last Updated
    November 16, 2011
    Sponsor
    Southern California University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00882271
    Brief Title
    Fibromyalgia Acupuncture Study
    Official Title
    Efficacy of Acupuncture to Improve Symptoms and Functionality for People With Fibromyalgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Southern California University of Health Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    Fibromyalgia, Acupuncture, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Traditional Chinese Acupuncture
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Acupuncture
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Ten Acupuncture treatments within six weeks
    Primary Outcome Measure Information:
    Title
    Health/Activity Questionnaire
    Time Frame
    Baseline
    Title
    The Fibromyalgia Impact Questionnaire
    Time Frame
    Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
    Title
    Multidimensional Pain Inventory
    Time Frame
    Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months
    Title
    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 Measure Information:
    Title
    30-sec Chair Stand
    Time Frame
    Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sivarama P Vinjamury, MD, MAOM
    Organizational Affiliation
    Southern California University of Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.scuhs.edu
    Description
    Visit Southern California University of Health Sciences Website

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