Developing Biomarkers for Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Developing Biomarkers for Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Traditional Acupuncture
* Other: Sham Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Acupuncture<br>Acupuncture sites will be used for active intervention. | Other: Traditional Acupuncture<br>* 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.<br>|
| Sham Comparator: Sham Treatment<br>Sham acupuncture is used. | Other: Sham Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI signal |  | pre treatment - week 1 | 
| PET signal |  | pre treatment - week 1 | 
| H-MRS Glutamate |  | pre treatment - week 1 | 
| fMRI signal |  | post treatment - week 5 | 
| PET signal |  | post treatment - week 5 | 
| H-MRS - Glutamate |  | post treatment - week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | pre treatment - week 1 | 
| Pain |  | post treatment - week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Healthy controls, Acupuncture, Sham Acupuncture, fMRI, Biological marker