Identification of Potential Biomarkers for Pain

Study Overview
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Brief Summary
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The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.

Detailed Description
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At the heart of the opioid epidemic is the lack of an objective measure of pain, which will help evaluate the validity of the patients' perception that the current dosage of opioid is sufficient of insufficient to alleviate pain. This study will test the quantifiable proteins such as S100B and BDNF will serve as objective measures (biomarkers) of pain. Fibromyalgia patients will be recruited into two groups-- one that uses opioids and the other that does not. Blood will be collected every 6 months for two years. The serum will be used to assay for levels of S100B and BDNF, The pressure-pain threshold (PPT) data, as part of standard of care, will also be collected. Correlation will the be assessed.

Official Title
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Development of a Serum Biomarker-Based Approach to Monitor Opioid Adherence and Minimize Substance Misuse in Chronic Pain Management

Conditions
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Fibromyalgia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Fibromyalgia Exclusion Criteria: Evidence of a history of substance abuse, neurological or oncologic disease, ischemic heart disease, kidney or hepatic insufficiency.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Opioid Usage<br>Patients that are currently diagnosed with fibromyalgia and taking opioids. | |
| No Opioid Usage<br>Patients that are currently diagnosed with fibromyalgia and are not taking opioids. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum protein levels as a marker for pain | Serum proteins will be assayed from patients. The correlation between the serum levels and the visual analog pain scale will be determined. 0 on the visual analog pain scale represents that their is no pain. 10 on the visual analog pain scale represents severe pain. | 2-4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if correlation may be established between impact of fibromyalgia and opioid doses | The prescribed opioid doses, if effective, will be expected to reduce/maintain the scores from the Revised Fibromyalgia Impact Questionnaire. Correlations will be determined through established statistical methods. The results from the FIQR can estimate the fibromyalgia severity and impact. | 2-4 years | 
| Determine if correlation may be established between sleep index and opioid doses | The prescribed opioid doses, if effective, will be expected to reduce/maintain the scores from the Sleep Questionnaire. Correlations will be determined through established statistical methods. This questionnaire can help determine the overall quality of person's sleep. | 2-4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, opioid, fibromyalgia