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| Name | Class |
|---|---|
| American Osteopathic Association | OTHER |
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The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Usage | Patients that are currently diagnosed with fibromyalgia and taking opioids. | ||
| No Opioid Usage | Patients that are currently diagnosed with fibromyalgia and are not taking opioids. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that are seen at the NeuroMusculoskeletal Institute at Rowan University School of Osteopathic Medicine.
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| Name | Affiliation | Role |
|---|---|---|
| Venkateswar Venkataraman, PhD | Rowan University School of Osteopathic Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rowan University School of Osteopathic Medicine | Stratford | New Jersey | 08084 | United States |
IPD will not be shared with other researchers.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Whole blood will be collected from the subjects. Serum and plasma will be obtained from the samples and retained.
| 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 |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |