Identification of Potential Biomarkers for Pain

NCT03495245 | Unknown

• 1 other identifier: Pro2017001740
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

pain; opioid; fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine if correlation may be established between impact of fibromyalgia and opioid doses

  2-4 years

• Determine if correlation may be established between sleep index and opioid doses

  2-4 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that are seen at the NeuroMusculoskeletal Institute at Rowan University School of Osteopathic Medicine.

You may qualify if:

• Diagnosed with Fibromyalgia

You may not qualify if:

• Evidence of a history of substance abuse, neurological or oncologic disease, ischemic heart disease, kidney or hepatic insufficiency.

Sponsors & Collaborators

• Rowan University: lead
• American Osteopathic Association: collaborator

Study Sites (1)

Rowan University School of Osteopathic Medicine

Stratford, New Jersey, 08084, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood will be collected from the subjects. Serum and plasma will be obtained from the samples and retained.

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Venkateswar Venkataraman, PhD

  Rowan University School of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: April 11, 2018
• Study Start: March 28, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2021
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)