Fibromyalgia Acupuncture Study

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882271
• Other study ID #: SCU-08-VINJ003
• Status: Completed
• Phase: N/A
• First received: April 14, 2009
• Last updated: November 16, 2011
• Start date: January 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: Southern California University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Acupuncture
Ten Acupuncture treatments within six weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southern California University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health/Activity Questionnaire		Baseline	No
Primary	The Fibromyalgia Impact Questionnaire		Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months	No
Primary	Multidimensional Pain Inventory		Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months	No
Primary	Beck Depression Inventory		Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months	No
Secondary	30-sec Chair Stand		Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months	No

External Links

•   Visit Southern California University of Health Sciences Website