Clinical trial NCT00932061: Developing Biomarkers for Fibromyalgia
Official title: Developing Biomarkers for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Healthy controls
Acupuncture
Sham Acupuncture
fMRI
Biological marker
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Dana Foundation
name: United States Department of Defense
First posted: 2009-07-02
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: fMRI signal
timeFrame: pre treatment - week 1
measure: PET signal
timeFrame: pre treatment - week 1
measure: H-MRS Glutamate
timeFrame: pre treatment - week 1
measure: fMRI signal
timeFrame: post treatment - week 5
measure: PET signal
timeFrame: post treatment - week 5
measure: H-MRS - Glutamate
timeFrame: post treatment - week 5
Secondary outcomes:
measure: Pain
timeFrame: pre treatment - week 1
measure: Pain
timeFrame: post treatment - week 5
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, Chronic Pain and Fatigue Research Center
state: Michigan
Study officials:
affiliation: Univeristy of Michigan, Chronic Pain & Fatigue Research Center
name: Richard Harris, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Sep;47(3):1077-85. doi: 10.1016/j.neuroimage.2009.05.083. Epub 2009 Jun 6.
citation: 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. doi: 10.1002/art.23223.
citation: 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. doi: 10.1523/JNEUROSCI.2849-07.2007.
citation: 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. doi: 10.1002/art.24849.
citation: 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 Aug;62(8):2545-55. doi: 10.1002/art.27497.