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Developing Biomarkers for Fibromyalgia

This study has been completed.
Sponsor:
Collaborators:
The Dana Foundation
Information provided by (Responsible Party):
Richard Harris, University of Michigan
ClinicalTrials.gov Identifier:
NCT00932061
First received: June 25, 2009
Last updated: July 18, 2013
Last verified: July 2013

June 25, 2009
July 18, 2013
June 2008
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • H-MRS Glutamate [ Time Frame: pre and post treatment - week 1 and week 5 ] [ Designated as safety issue: No ]
  • fMRI signal [ Time Frame: pre and post treatment - week 1 and week 5 ] [ Designated as safety issue: No ]
  • PET signal [ Time Frame: pre and post treatment - week 1 and week 5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00932061 on ClinicalTrials.gov Archive Site
  • Pain [ Time Frame: pre treatment - week 1 ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: post treatment - week 5 ] [ Designated as safety issue: No ]
Pain [ Time Frame: pre and post treatment - week 1 and week 5 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Developing Biomarkers for Fibromyalgia
Developing Biomarkers for Fibromyalgia

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Fibromyalgia
  • 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.

  • 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.

  • Active Comparator: Traditional Acupuncture
    Acupuncture sites will be used for active intervention.
    Intervention: Other: Traditional Acupuncture
  • Sham Comparator: Sham Treatment
    Sham acupuncture is used.
    Intervention: Other: Sham Treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932061
Hum 00010061, F017513, Sponsor(DOD) W81XWH-07-20050
No
Richard Harris, University of Michigan
University of Michigan
  • The Dana Foundation
  • Department of Defense
Principal Investigator: Richard Harris, Ph.D. Univeristy of Michigan, Chronic Pain & Fatigue Research Center
University of Michigan
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP