ERASED: Examining Racial and Socioeconomic Differences in Chronic Low Back Pain

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05991440

Collaborator

National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

240

Enrollment

Location

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to gain a better understanding of how people's racial background and socioeconomic status (e.g., income, education, and employment) impact their experiences of chronic low back pain (cLBP).

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Racial and Socioeconomic Differences in Chronic Low Back Pain

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2027

Outcome Measures

Primary Outcome Measures

To elucidate racial group disparities in clinical symptoms among NHBs and NHWs with cLBP. [two years]
Clinical pain severity will be observed through quantitative sensory testing and self-reported questionnaires and surveys.
To elucidate racial group disparities in experimental pain sensitivity among NHBs and NHWs with cLBP. [two years]
Quantitative sensory testing equipment and biological markers assayed via blood samples.
To elucidate racial group disparities in psychosocial risk factors, among NHBs and NHWs with cLBP. [two years]
Psychosocial risk factors that will be observed will be greater increases in depressive symptoms, anxiety, and perceived stress, as well as greater social isolation and loneliness through the use of self-reported questionnaires and surveys.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion:

Non-specific cLBP that has persisted for at least 3 months and has resulted in pain on at least half the days in the past 6 months.
Age 18 - 85; the lower end of this age range was chosen to capture the growing prevalence of young adults with cLBP, and participants over 85 years are increasingly likely to meet one or more exclusion criteria.
Participants report ethnic group as non-Hispanic and racial group as either Black/African American or White/Caucasian.

Exclusion:

Low back pain that is attributable to other factors such as ankylosing spondylitis, infection, malignancy, compression fracture of other trauma.
Systemic rheumatic disease/condition (e.g. rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia).
Any other chronic pain condition that the participant believes to be more prominent or severe than the low back pain.
A history of clinically significant surgery to the low back within the past year.
Uncontrolled hypertension (i.e. SBP/DBP of > 150/95), cardiovascular or peripheral arterial disease.
Poorly controlled diabetes (HbA1c > 8%).
Neurological disease (e.g. Parkinson's, multiple sclerosis, epilepsy).
Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation.
Diminished cognitive function that would interfere with understanding of study procedures.