Identification of Potential Biomarkers for Pain

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03495245
• Other study ID #: Pro2017001740
• Status: Active, not recruiting
• Start date: March 28, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2019
• Source: Rowan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Locations

Country	Name	City	State
United States	Rowan University School of Osteopathic Medicine	Stratford	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rowan University	American Osteopathic Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum protein levels as a marker for pain	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.	2-4 years
Secondary	Determine if correlation may be established between impact of fibromyalgia and opioid doses	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.	2-4 years
Secondary	Determine if correlation may be established between sleep index and opioid doses	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.	2-4 years