Developing Biomarkers for Fibromyalgia

Fibromyalgia Clinical Trial

— Biomarkers  

Official title:

Developing Biomarkers for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932061
• Other study ID #: Hum 00010061
• Secondary ID: F017513Sponsor(D
• Status: Completed
• Phase: N/A
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

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 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.

Locations

Country	Name	City	State
United States	University of Michigan, Chronic Pain and Fatigue Research Center	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	The Dana Foundation, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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: — View 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.neuroima — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI signal		pre treatment - week 1
Primary	PET signal		pre treatment - week 1
Primary	H-MRS Glutamate		pre treatment - week 1
Primary	fMRI signal		post treatment - week 5
Primary	PET signal		post treatment - week 5
Primary	H-MRS - Glutamate		post treatment - week 5
Secondary	Pain		pre treatment - week 1
Secondary	Pain		post treatment - week 5

External Links

•   Chronic Pain and Fatigue Research Center
•   University of Michigan Research Studies