Examining Racial and Socioeconomic Differences in Chronic Low Back Pain

Chronic Pain Clinical Trial

— ERASED  

Official title:

Racial and Socioeconomic Differences in Chronic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05991440
• Other study ID #: 202306132
• Secondary ID: R01MD017565
• Status: Recruiting
• Start date: April 22, 2024
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Burel R Goodin, PhD
• Phone: 314-273-6403
• Email: burel[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To elucidate racial group disparities in clinical symptoms among NHBs and NHWs with cLBP.	Clinical pain severity will be observed through quantitative sensory testing and self-reported questionnaires and surveys.	two years
Primary	To elucidate racial group disparities in experimental pain sensitivity among NHBs and NHWs with cLBP.	Quantitative sensory testing equipment and biological markers assayed via blood samples.	two years
Primary	To elucidate racial group disparities in psychosocial risk factors, among NHBs and NHWs with cLBP.	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.	two years