Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Mechanisms of Acupuncture Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142597
• Other study ID #: K01AT001111-01
• Secondary ID: K01AT001111-011K
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 1, 2005
• Last updated: April 9, 2015
• Start date: May 2005
• Est. completion date: March 2011

Study information

• Verified date: December 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mu-opioid Receptor Occupancy	Here we report the change (post - pre) in mu-opioid receptor binding potential (BP) for the perigenual anterior cingulate. BP is a unitless measure and reflects the total maximum binding of receptors divided by the dissociation constant. BP = Bmax/Kd.	measured from baseline to week 5	No