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Developing Biomarkers for Fibromyalgia (Biomarkers)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932061
First Posted: July 2, 2009
Last Update Posted: July 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Dana Foundation
United States Department of Defense
Information provided by (Responsible Party):
Richard Harris, University of Michigan
  Purpose
The hypothesis of this study is that biological markers are present in the body that are good indicators of chronic pain. Eligible participants will be assessed at baseline and after receiving a series of acupuncture or "sham" acupuncture (something that resembles, but is not, active acupuncture) sessions. If the subject qualifies for the investigators' research and are subsequently enrolled in this study, they will be randomly assigned (like the flip of a coin) to one of these two groups. Acupuncture, as previously shown by this group, leads to improvements in both clinical and evoked pain associated with fibromyalgia. The study involves two magnetic resonance imaging (MRI) brain scans, one at the beginning and one at the end of the study. Another optional portion of the study would involve 2 PET (positron emission tomography) scans of the subject's brain, one at the beginning and one at the end of the study; this type of scan allows us to get more specific information about the subject's brain function during an acupuncture session.

Condition Intervention
Fibromyalgia Other: Traditional Acupuncture Other: Sham Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Developing Biomarkers for Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Richard Harris, University of Michigan:

Primary Outcome Measures:
  • fMRI signal [ Time Frame: pre treatment - week 1 ]
  • PET signal [ Time Frame: pre treatment - week 1 ]
  • H-MRS Glutamate [ Time Frame: pre treatment - week 1 ]
  • fMRI signal [ Time Frame: post treatment - week 5 ]
  • PET signal [ Time Frame: post treatment - week 5 ]
  • H-MRS - Glutamate [ Time Frame: post treatment - week 5 ]

Secondary Outcome Measures:
  • Pain [ Time Frame: pre treatment - week 1 ]
  • Pain [ Time Frame: post treatment - week 5 ]

Enrollment: 105
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional Acupuncture
Acupuncture sites will be used for active intervention.
Other: Traditional Acupuncture

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

Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.

Sham Comparator: Sham Treatment
Sham acupuncture is used.
Other: Sham Treatment

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

Subjects enrolled in the study may have 1) only fMRI or 2) fMRI scans and PET scans, depending on their eligibility criteria.


  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria for Fibromyalgia Volunteers:

  • 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
  • Be capable of giving written informed consent

Inclusion Criteria for Healthy Volunteers:

  • Willing to refrain from alcohol intake for 48 hours prior to brain scans
  • Be right handed
  • Be capable of giving written informed consent

PET Inclusion Criteria:

  • Willing to refrain from alcohol intake 48 hours prior to brain scans
  • Capable of giving written consent

Exclusion Criteria:

Exclusion Criteria for Fibromyalgia Volunteers:

  • 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

Exclusion for Healthy Volunteers:

  • Autoimmune or inflammatory disease (in addition to fibromyalgia) that causes pain (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease)
  • Having met the ACR criteria for FM
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932061


Locations
United States, Michigan
University of Michigan, Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
University of Michigan
The Dana Foundation
United States Department of Defense
Investigators
Principal Investigator: Richard Harris, Ph.D. Univeristy of Michigan, Chronic Pain & Fatigue Research Center
  More Information

Additional Information:
Publications:
Responsible Party: Richard Harris, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00932061     History of Changes
Other Study ID Numbers: Hum 00010061
F017513
Sponsor(DOD) W81XWH-07-20050
First Submitted: June 25, 2009
First Posted: July 2, 2009
Last Update Posted: July 19, 2013
Last Verified: July 2013

Keywords provided by Richard Harris, University of Michigan:
Fibromyalgia
Healthy controls
Acupuncture
Sham Acupuncture
fMRI
Biological marker

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