Identification of Potential Biomarkers for Pain

• Conditions: Fibromyalgia

• Registration Number: NCT03495245
• Lead Sponsor: Rowan University

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.

Study Timeline

• Study First Submitted: 2018-01-18
• Study Start: 2018-03-28
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-17
• Last Update Posted: 2019-11-19
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum protein levels as a marker for pain	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 Outcome Measures

Name	Time	Method
Determine if correlation may be established between impact of fibromyalgia and opioid doses	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.; The results from the FIQR can estimate the fibromyalgia severity and impact.
Determine if correlation may be established between sleep index and opioid doses	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.; This questionnaire can help determine the overall quality of person's sleep.

Trial Locations

Locations (1)

Rowan University School of Osteopathic Medicine; 🇺🇸 Stratford, New Jersey, United States