Fibromyalgia Acupuncture Study
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Acupuncture, Pain
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.
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
NCT ID
NCT00882271
First Posted
April 14, 2009
Last Updated
November 16, 2011
Sponsor
Southern California University of Health Sciences
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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