Development of a Serum Biomarker-Based Approach to Monitor Opioid Adherence and Minimize Substance Misuse in Chronic Pain Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Rowan University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Serum protein levels as a marker for pain
- Last Updated
- 6 years ago
Overview
Brief Summary
The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.
Detailed Description
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.
Investigators
Venkat Venkataraman, PhD
Assistant Professor
Rowan University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Serum protein levels as a marker for pain
Time Frame: 2-4 years
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.
Secondary Outcomes
- Determine if correlation may be established between impact of fibromyalgia and opioid doses(2-4 years)
- Determine if correlation may be established between sleep index and opioid doses(2-4 years)