Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

This study will determine the effectiveness of acupuncture versus a placebo in altering brain activity and relieving pain due to fibromyalgia.

Key facts

Study ID

NCT00142597

Run by

University of Michigan

People needed

46

Starts

2005-05-01

Expected to finish

2011-03-01

Last updated by the study team

2015-04-13

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• fMRI Inclusion Criteria:
• Has met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia for at least 1 year
• Chronic pain more than 50% of days
• Willing to limit introduction of any new medications or treatments for fibromyalgia during the study
• Able to attend study visits up to three times weekly
• Right-handed
• Must be within driving distance of Ann Arbor, MI
• PET Inclusion Criteria:
• Meets fMRI inclusion criteria
• Willing to refrain from alcohol intake for 48 hours prior to PET studies

You may not qualify if…

• fMRI Exclusion Criteria:
• Knowledge that could prevent "blinding" of the participant to the study interventions (including previous acupuncture treatment)
• Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture
• Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
• Daily use of narcotic pain-relievers
• History of substance abuse
• Simultaneous participation in other therapeutic trials
• Pregnant or breastfeeding
• Current severe psychiatric illness (e.g., schizophrenia, major depression with suicidal ideation)
• Condition that may make exposure to fMRI medically inadvisable
• Any condition that may prevent satisfactory completion of the study protocol
• PET Exclusion Criteria:
• Meets any of the fMRI exclusion criteria
• Current major depression
• Condition that may make exposure to PET medically inadvisable

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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