Developing Biomarkers for Fibromyalgia - Full Text View

Sponsor:	University of Michigan
Collaborators:	The Dana Foundation Department of Defense
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00932061

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:

MedlinePlus related topics: Acupuncture Acute Bronchitis Fibromyalgia Nuclear Scans

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 2012
Estimated Primary Completion Date:	March 2012 (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

Contacts

Contact: Craig Urwin, B.S	734-998-7023	craijose@umich.edu
Contact: Katherine Scott, BSN	734-998-7022	jrsj@umich.edu

Locations

United States, Michigan
University of Michigan, Chronic Pain and Fatigue Research Center	Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Craig Urwin, B.S. 734-998-7023 craijose@umich.edu
Contact: Katherine Scott, BSN 734-998-7022 jrsj@umich.edu
Principal Investigator: Richard Harris, Ph.D.

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:

Harris RE, Zubieta JK, Scott DJ, Napadow V, Gracely RH, Clauw DJ. Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on mu-opioid receptors (MORs). Neuroimage. 2009 Jun 6; [Epub ahead of print]

Harris RE, Sundgren PC, Pang Y, Hsu M, Petrou M, Kim SH, McLean SA, Gracely RH, Clauw DJ. Dynamic levels of glutamate within the insula are associated with improvements in multiple pain domains in fibromyalgia. Arthritis Rheum. 2008 Mar;58(3):903-7.

Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6.

Harris RE, Sundgren PC, Craig AD, Kirshenbaum E, Sen A, Napadow V, Clauw DJ. Elevated insular glutamate in fibromyalgia is associated with experimental pain. Arthritis Rheum. 2009 Oct;60(10):3146-52.

Napadow V, Lacount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Apr 6; [Epub ahead of print]

Responsible Party:	Richard Harris, Ph.D., Chronic Pain and Fatigue Research Center
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:	August 8, 2011
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 February 09, 2012