NCT05991440

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Apr 2024Dec 2028

First Submitted

Initial submission to the registry

July 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

3.7 years

First QC Date

July 31, 2023

Last Update Submit

July 9, 2025

Conditions

Keywords

lower back painRaceSocioeconomic

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Participants report ethnic group as non-Hispanic and racial group as either Black/African American or White/Caucasian.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected for analysis

MeSH Terms

Conditions

Chronic PainLow Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Study Officials

  • Burel Goodin, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Burel R Goodin, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof of Anesthesiology

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 14, 2023

Study Start

April 22, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations