Fibromyalgia Acupuncture Study

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Acupuncture

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
30-sec Chair Stand	Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months

Collaborators and Investigators

• Sponsor: Southern California University of Health Sciences
• Investigators: Principal Investigator: Sivarama P Vinjamury, MD, MAOM, Southern California University of Health Sciences

Publications and helpful links

Helpful Links

• Visit Southern California University of Health Sciences Website

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: April 14, 2009
• First Submitted That Met QC Criteria: April 15, 2009
• First Posted (Estimate): April 16, 2009

Study Record Updates

• Last Update Posted (Estimate): November 18, 2011
• Last Update Submitted That Met QC Criteria: November 16, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Pain; Acupuncture; Fibromyalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: SCU-08-VINJ003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No