Identification of Potential Biomarkers for Pain

NCT ID: NCT03495245

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-28

Study Completion Date

2021-09-30

Brief Summary

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The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.

Detailed Description

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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.

Conditions

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Fibromyalgia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Opioid Usage

Patients that are currently diagnosed with fibromyalgia and taking opioids.

No interventions assigned to this group

No Opioid Usage

Patients that are currently diagnosed with fibromyalgia and are not taking opioids.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Osteopathic Association

OTHER

Sponsor Role collaborator

Rowan University

OTHER

Sponsor Role lead

Responsible Party

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Venkat Venkataraman, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Venkateswar Venkataraman, PhD

Role: PRINCIPAL_INVESTIGATOR

Rowan University School of Osteopathic Medicine

Locations

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Rowan University School of Osteopathic Medicine

Stratford, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Pro2017001740

Identifier Type: -

Identifier Source: org_study_id

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