Recruiting NCT05991440
Examining Racial and Socioeconomic Differences in Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Racial and Socioeconomic Differences in Chronic Low Back Pain
Overview
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).
Primary outcome measures
- To elucidate racial group disparities in clinical symptoms among NHBs and NHWs with cLBP. [Time frame: two years]
- To elucidate racial group disparities in experimental pain sensitivity among NHBs and NHWs with cLBP. [Time frame: two years]
- To elucidate racial group disparities in psychosocial risk factors, among NHBs and NHWs with cLBP. [Time frame: two years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT05991440 · 202306132 · R01MD017565