Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia

NCT ID: NCT00142597

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2011-03-31

Brief Summary

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

Detailed Description

Fibromyalgia is one of the most common rheumatic diseases, second only to osteoarthritis. It causes chronic muscle pain and fatigue. Acupuncture functions by targeting specific nerve pathways to different organs or parts of the body. Research has shown that acupuncture is effective in decreasing or eliminating people's sensitivity to pain in targeted regions. However, some believe that the reduction in pain is due to a placebo response rather than acupuncture itself. This study will use two brain-imaging techniques to determine the brain response to acupuncture versus a simulation of acupuncture, thereby assessing whether acupuncture is actually effective in relieving pain.

Participants in this single-blind study will be randomly assigned to receive either acupuncture or a placebo treatment. The placebo will consist of a simulation of acupuncture. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) will be used to assess activity of brain mu-opioid receptors. These receptors are involved in the body's ability to perceive pain. All participants will be scanned twice using the fMRI scanner, once before any treatment sessions and once at the conclusion of all treatment sessions. Both fMRI sessions will involve applying pressure to the thumb to elicit a response in the brain in order to assess the corresponding fMRI blood oxygen level dependent (BOLD) signal and whether this activation changes after treatment intervention. Participants will then receive nine treatments of acupuncture or placebo outside the scanner over a 4-week period. The PET portion of this study is optional, and, if you elect to participate, your first treatment session will be performed in the PET scanner. After this first session, participants will have seven additional treatment sessions outside of the scanner over a 4-week period. The last session will be performed in the PET scanner to assess changes in mu-opioid receptor activity that may have occurred over the 4 weeks. A baseline visit to determine eligibility and a close-out visit at week 8 are also part of the participation schedule. It is very important that participants live within driving distance of Ann Arbor, MI due to the significant number of visits to our Center.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional Acupuncture

Acupuncture sites will be used for active intervention.

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: DEVICE

Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.

Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.

All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.

Sham Treatment

Sham acupuncture is used.

Group Type: SHAM_COMPARATOR

Sham treatment

Intervention Type: OTHER

Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.

All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.

Interventions

Acupuncture

Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.

Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.

All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.

Intervention Type: DEVICE

Sham treatment

Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.

All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional.

Intervention Type: OTHER

Eligibility Criteria

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

• Willing to refrain from alcohol intake for 48 hours prior to PET studies

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

• Current major depression
• Condition that may make exposure to PET medically inadvisable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Richard Harris

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard E. Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Harris RE, Sundgren PC, Pang Y, Hsu M, Petrou M, Kim SH, McLean SA, Gracely RH, Clauw DJ. Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia. Arthritis Rheum. 2008 Mar;58(3):903-7. doi: 10.1002/art.23223.

Reference Type: DERIVED

PMID: 18311814 (View on PubMed)

Other Identifiers

K01AT001111-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1K01AT001111-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K01AT001111-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link