Identification of Potential Biomarkers for Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03495245|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Development of a Serum Biomarker-Based Approach to Monitor Opioid Adherence and Minimize Substance Misuse in Chronic Pain Management|
|Estimated Study Start Date :||May 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2021|
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.
- 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.
- Determine if correlation may be established between impact of fibromyalgia and opioid doses [ Time Frame: 2-4 years ]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.
- Determine if correlation may be established between sleep index and opioid doses [ Time Frame: 2-4 years ]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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495245
|Contact: Lauren Fedor, CCRPemail@example.com|
|United States, New Jersey|
|Rowan University School of Osteopathic Medicine||Recruiting|
|Stratford, New Jersey, United States, 08084|
|Contact: Lauren Fedor, CCRP 856-566-6003 firstname.lastname@example.org|
|Principal Investigator:||Venkateswar Venkataraman, PhD||Rowan University School of Osteopathic Medicine|