Fibromyalgia Acupuncture Study

NCT00882271 | Completed DMC

• 1 other identifier: SCU-08-VINJ003
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Acupuncture; Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 30-sec Chair Stand

  Baseline and end of 5th, 10th treatments and end of 1, 2, 3, 4, 5, and 6 months

Study Arms (2)

1

EXPERIMENTAL

Traditional Chinese Acupuncture

Other: Acupuncture

2

PLACEBO COMPARATOR

Placebo Acupuncture

Other: Acupuncture

Interventions

Acupuncture OTHER

Ten Acupuncture treatments within six weeks

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California University of Health Sciences: lead

Related Links

• Visit Southern California University of Health Sciences Website

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Sivarama P Vinjamury, MD, MAOM

  Southern California University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fibromyalgia Acupuncture Study

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 16, 2009
• Study Start: January 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 18, 2011

Record last verified: 2011-11