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Developing Biomarkers for Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Dana Foundation
Department of Defense
Information provided by (Responsible Party):
Richard Harris, University of Michigan
ClinicalTrials.gov Identifier:
NCT00932061
First received: June 25, 2009
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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 Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Developing Biomarkers for Fibromyalgia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • fMRI signal [ Time Frame: pre treatment - week 1 ] [ Designated as safety issue: No ]
  • PET signal [ Time Frame: pre treatment - week 1 ] [ Designated as safety issue: No ]
  • H-MRS Glutamate [ Time Frame: pre treatment - week 1 ] [ Designated as safety issue: No ]
  • fMRI signal [ Time Frame: post treatment - week 5 ] [ Designated as safety issue: No ]
  • PET signal [ Time Frame: post treatment - week 5 ] [ Designated as safety issue: No ]
  • H-MRS - Glutamate [ Time Frame: post treatment - week 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: pre treatment - week 1 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: post treatment - week 5 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Department of Defense
Investigators
Principal Investigator: Richard Harris, Ph.D. Univeristy of Michigan, Chronic Pain & Fatigue Research Center
  More Information

Additional Information:
University of Michigan Research Studies  This link exits the ClinicalTrials.gov site
Chronic Pain and Fatigue Research Center  This link exits the ClinicalTrials.gov site

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
Study First Received: June 25, 2009
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013