Clinical trial NCT05991440: Examining Racial and Socioeconomic Differences in Chronic Low Back Pain
Official title: Racial and Socioeconomic Differences in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: lower back pain
Race
Socioeconomic
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-08-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study we will incorporate a combination of clinic-based and community-based participant recruitment. Participants will be recruited from the Pain Treatment Clinics at the Wash U Pain Center and VUMC, as well as the surrounding communities in St. Louis and Nashville, respectively.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: To elucidate racial group disparities in clinical symptoms among NHBs and NHWs with cLBP.
timeFrame: two years
measure: To elucidate racial group disparities in experimental pain sensitivity among NHBs and NHWs with cLBP.
timeFrame: two years
measure: To elucidate racial group disparities in psychosocial risk factors, among NHBs and NHWs with cLBP.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Burel Goodin, PhD
role: PRINCIPAL_INVESTIGATOR
References: