Effectiveness of Acupuncture in Relieving Pain Due to Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Harris, University of Michigan
ClinicalTrials.gov Identifier:
NCT00142597
First received: September 1, 2005
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
Fibromyalgia
Device: Acupuncture
Other: Sham treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Mechanisms of Acupuncture Analgesia

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in mu-opioid receptor occupancy [ Time Frame: measured from baseline to week 5 ] [ Designated as safety issue: No ]
  • Change in fMRI BOLD signal [ Time Frame: measured from baseline to week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in clinical pain as assessed by the McGill Pain and other questionnaires [ Time Frame: measured from baseline to week 8 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: May 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Acupuncture
Acupuncture sites will be used for active 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.

Sham Comparator: Sham Treatment
Sham acupuncture is used.
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142597

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Richard E. Harris, PhD University of Michigan
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Harris, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00142597     History of Changes
Other Study ID Numbers: K01 AT001111-01, K01AT001111-01, 1-K01-AT01111-01
Study First Received: September 1, 2005
Last Updated: January 23, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
acupuncture
analgesia
pain
fibromyalgia
fMRI
PET

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014