Identification of Potential Biomarkers for Pain

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03495245

Enrollment

200

Registered

2018-04-11

Start date

2018-03-28

Completion date

2021-09-30

Last updated

2019-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

pain, opioid, fibromyalgia

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results