Fibromyalgia Acupuncture Study

Sponsor

Southern California University of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00882271

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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	Phase
Fibromyalgia	Other: Acupuncture	N/A

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

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 :

Jan 1, 2008

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

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

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

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

Secondary Outcome Measures

30-sec Chair Stand [Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.