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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495245
Recruitment Status : Unknown
Verified November 2019 by Venkat Venkataraman, PhD, Rowan University.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2018
Last Update Posted : November 19, 2019
Sponsor:
Collaborator:
American Osteopathic Association
Information provided by (Responsible Party):
Venkat Venkataraman, PhD, Rowan University

Study Description
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Brief Summary:
The study investigates the potential of using serum biomarkers to assess pain in fibromyalgia patients.

Condition or disease
Fibromyalgia

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Development of a Serum Biomarker-Based Approach to Monitor Opioid Adherence and Minimize Substance Misuse in Chronic Pain Management
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Groups and Cohorts
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Group/Cohort
Opioid Usage
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

    The results from the FIQR can estimate the fibromyalgia severity and impact.


  2. 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.

    This questionnaire can help determine the overall quality of person's sleep.



Biospecimen Retention:   Samples Without DNA
Whole blood will be collected from the subjects. Serum and plasma will be obtained from the samples and retained.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that are seen at the NeuroMusculoskeletal Institute at Rowan University School of Osteopathic Medicine.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New Jersey
Rowan University School of Osteopathic Medicine
Stratford, New Jersey, United States, 08084
Sponsors and Collaborators
Rowan University
American Osteopathic Association
Investigators
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Principal Investigator: Venkateswar Venkataraman, PhD Rowan University School of Osteopathic Medicine
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Venkat Venkataraman, PhD, Assistant Professor, Rowan University
ClinicalTrials.gov Identifier: NCT03495245    
Other Study ID Numbers: Pro2017001740
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Venkat Venkataraman, PhD, Rowan University:
pain
opioid
fibromyalgia
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases