Back Pain Lower Back ChronicERASEDNCT03338192
Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
An observational study of Back Pain Lower Back Chronic, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- QST
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2017to 31 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- Adult, Older adult
Study population: Men and woman white Caucasian and African American with Chrionic low back pain between the ages of 19-85.
Who may be able to join
- Chronic low back pain that has been going on consistently for the last 6 months.
Who cannot join
- Surgery (fusion, Laminectomy) in the last year, accident or trauma in the last year, uncontrolled high blood pressure, heart disease, cancer, diabetes HbA1c > 7%, Ankylosing Spondylitis, Infection, Parkinson's Disease, Multiple Sclerosis, Epilepsy, Stroke, Seizure (non-epileptic), Systemic Lupus Erythematosus, Fibromyalgia, Raynaud's disease, Major Depression/Bipolar Disorder, HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Racial and Socioeconomic Differences in Chronic Low Back Pain
It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability. Further, guided by the theory of fundamental causes, we aim to examine racial and socioeconomic status differences in biopsychosocial predictors of cLBP outcomes, particularly endogenous pain modulation.
Read the detailed description
Experimental session 1
Resting Blood Pressure and Body Mass Index will be assessed. Participants will complete the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. Participants will complete multiple questionnaires to measure Socioeconomic Status, Clinical Pain Assessment and Depression Scale. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Between Experimental Session 1 and Experimental Session 2
Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1.
Experimental Session 2
Experimental session 2 will take place in the CCTS Clinical Research Unit (CRU) All blood will be collected as part of a single draw by research nurses. Participants will complete multiple questionnaires to measure Clinical Pain Assessment and Coping Strategies. Participants will then complete a battery of ecologically valid movement tasks that include: 1) getting in and out of a bed; 2) sitting in a chair, transitioning to a standing position, and then sitting again, and 3) lifting, Performance Battery (SPPB) and the Timed Up and Go test (TUG). Blood will be processed and stored and then used to measure Vitamin D, CRP assays and Oxytocin. Finally follow up data will be collected by phone once per week for four weeks following the completion of study session 2.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- QST
- Keywords
- Low back pain, Chronic pain, Health disparities in chronic low back pain
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QSTOther
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| African American/Black QST | This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain. Receives: Other: QST | |
| Caucasian/White QST | This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain. Receives: Other: QST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Clinical Pain Severity
The Brief Pain Inventory Short-Form (BPI-SF) was used to assess clinical pain severity. Four items assessed participants' average, least, and worst pain over the past 24hours, as well as current pain (0=no pain, 10=pain as bad as you can imagine). These 4 items were averaged for a total score (range: 0-10).
Measured: Baseline to one week.
Secondary outcomes (13)
Average Pain Threshold (Heat)
Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain threshold, participants will be instructed to press the button when the sensation "first becomes painful". Heat pain threshold was assessed at the lumbar spine. On a scale of 32 degrees Celsius to 51 degrees Celsius, with 51 being the hottest temperature.
Measured: Baseline
Average Pain Tolerance (Heat)
Pain tolerance refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate. Heat stimuli will again be delivered using the computer-controlled thermal stimulation system. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain tolerance, participants will be instructed to press the button when they are "no longer willing to tolerate" the painful sensation. Heat pain tolerance was assessed at the lumbar spine. Scale range from 32 degrees Celsius to 51 degrees Celsius with 51 being the hottest.
Measured: Baseline
Difference in Temporal Summation of Pain (Mechanical)
Temporal summation of pain refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input. Temporal summation is presumed to be the psychophysical manifestation of wind-up. Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater than 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord. Temporal summation was assessed at the lumbar spine using a 512 milliNewton punctate probe. Participants are stimulated once with the punctate probe and asked to provide a pain rating from 0-100 whereby 0 = no pain and 100 = most intense pain imaginable. They are then stimulated 10 consecutive times with the punctate probe and asked to provide another pain rating from 0-100. Temporal summation is the difference between these two ratings, such that positive scores indicate pain facilitation and negative scores indicate pain inhibition.
Measured: Baseline
Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation
Pressure was manually applied and increased at a rate of 30 kPa/s. Participants indicated when the pressure was first perceived to be painful (pressure pain threshold) via button-push. Three applications of a handheld algometer were used to determine baseline pressure pain thresholds (PPTs). Following this, participants underwent two trials of cold pressor immersion. Participants placed their entire hand, up to the wrist, into 12 °C water for 60 s. Immediately following withdrawal of the hand from the cold pressor, the algometer was re-applied at the lumbar region. Participants again indicated when they first perceived the pressure as painful (conditioned PPT). The trial was repeated following a two-minute rest period. The baseline PPTs were averaged, as were the two conditioned PPTs. Conditioned pain modulation was calculated as the difference between Conditioned PPT - Baseline PPT. Positive difference scores indicate pain inhibition and negative scores indicate facilitation.
Measured: Baseline
Total Level of C-reactive Protein
A single blood draw was collected from each participant during their one week follow up visit. The blood was processed and serum was used to quantify C-reactive protein, which is a marker of systemic pro-inflammation. Increasing levels of C-reactive protein are suggestive of greater inflammation.
Measured: One week follow up
Total Level of Fibrinogen
Fibrinogen is a protein that plays a crucial role in blood clotting. It is produced by the liver and is present in the blood plasma. Fibrinogen is considered a key player in inflammation, acting as a pro-inflammatory molecule by directly interacting with immune cells and promoting their migration to the site of injury, essentially serving as a "scaffold" for the inflammatory response, and its levels significantly increase during inflammatory conditions, making it a marker for inflammation in the body; high fibrinogen levels often indicate an ongoing inflammatory process.
Measured: One week follow up
Total Level of Serum Amyloid A
Serum amyloid A (SAA) is considered a key marker of inflammation, as its levels significantly increase in the blood during an inflammatory response, acting as an "acute phase reactant" produced by the liver when stimulated by pro-inflammatory cytokines like interleukin-6 (IL-6); essentially, high SAA levels indicate the presence of active inflammation in the body.
Measured: One week follow up
Total Level of Vitamin D
Vitamin D (also referred to as calciferol) is a fat-soluble vitamin that is naturally present in a few foods, added to others, and available as a dietary supplement. It is also produced endogenously when ultraviolet (UV) rays from sunlight strike the skin and trigger vitamin D synthesis. We quantified Vitamin D from blood serum. Lower levels of Vitamin D have been associated with greater musculoskeletal pain severity and worse bone and muscle health.
Measured: One week follow up
Total Level of Oxytocin
Oxytocin is a hormone that plays a crucial role in various physiological and behavioral processes, particularly in reproduction, social bonding, and emotional well-being.
Measured: One week follow up
Sleep Quality
Insomnia Severity Index (ISI) was used to measure sleep quality. The ISI is a seven-item questionnaire used to evaluate the severity and impact of insomnia. Participants used a 5-point Likert scale to rate severity of difficulties with sleep onset and sleep maintenance as well as problems with early morning awakenings, sleep dissatisfaction, and interference of sleep difficulties with daytime functioning within the last month. Items are summed to calculate a total score ranging from 0 to 28, thus, indicating absence of insomnia (0-7), subthreshold insomnia (8-14), moderate insomnia (15-21) and severe insomnia (22-28).
Measured: Between baseline and one week follow-up
Self-reported Disability
Self-reported disability was assessed using the Graded Chronic Pain Scale (GCPS) - interference scale. A higher score on the interference section indicates a greater level of disruption to daily life due to pain. The GCPS scale ranges from 0-100 and higher scores are indicative of greater self-reported disability.
Measured: One week follow up
Evoked Pain With Movement
The Short Physical Performance Battery was used to assess movement-evoked pain. Participants completed three movements (balance, chair stands, and walking). After completion of each movement task, participants were asked to provide a pain intensity rating for any movement-evoked pain experienced during completion of the balance, chair stands, and walking tests. The 0-100 numeric rating scale was utilized for this purpose, whereby: (0 = no pain and 100 = most intense pain imaginable). Average pain intensity was calculated across the three movements.
Measured: One week follow up
Functional Performance
The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in adults. The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility. Scores range from 0 to 12 with higher scores suggest of better functional performance.
Measured: One week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start15 Oct 2017
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Burel Goodin, University of Alabama at Birmingham
- Investigators
- Burel Goodin, PhD, Principal investigator, University of Alabama at Birmingham Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338192
- Sponsor's protocol ID
- F170119003
- Other IDs
- R01MD010441
- Acronym
- ERASED
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2017
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas PA, Ditta PV, Stocking SQ, Webb C, Meints SM, Owens MA, Quinn T, Aroke EN, Morris MC, Sorge RE, Goodin BR, Overstreet DS. The effects of neighborhood disadvantage and adverse childhood experiences on conditioned pain modulation in adults with chronic low back pain. J Pain. 2025 Dec;37S:105566. doi: 10.1016/j.jpain.2025.105566. Epub 2025 Dec 9.
PubMed 41381165Thomas PA, Ditta PV, Stocking SQ, Webb C, Meints SM, Owens MA, Quinn T, Aroke EN, Morris MC, Sorge RE, Goodin BR, Overstreet DS. The effects of neighborhood disadvantage and adverse childhood experiences on conditioned pain modulation in adults with chronic low back pain. J Pain. 2025 Jan;26:104706. doi: 10.1016/j.jpain.2024.104706. Epub 2024 Oct 16.
PubMed 39424112Thomas PA, Goodin BR, Meints SM, Owens MA, Wiggins AM, Quinn T, Long L, Aroke EN, Morris MC, Sorge RE, Overstreet DS. Adverse Childhood Experiences and Chronic Low Back Pain in Adulthood: The Role of Emotion Regulation. J Pain. 2024 Sep;25(9):104551. doi: 10.1016/j.jpain.2024.104551. Epub 2024 Apr 29.
PubMed 38692399Overstreet DS, Strath LJ, Sorge RE, Thomas PA, He J, Wiggins AM, Hobson J, Long DL, Meints SM, Aroke EN, Goodin BR. Race-specific associations: inflammatory mediators and chronic low back pain. Pain. 2024 Jul 1;165(7):1513-1522. doi: 10.1097/j.pain.0000000000003154. Epub 2024 Feb 6.
PubMed 38323608
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial and Socioeconomic Differences in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03338192
- Acronym / sponsor ID
- ERASED / F170119003
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Low back pain, Chronic pain, Health disparities in chronic low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability. Further, guided by the theory of fundamental causes, we aim to examine racial and socioeconomic status differences in biopsychosocial predictors of cLBP outcomes, particularly endogenous pain modulation.
Detailed description
Experimental session 1
Resting Blood Pressure and Body Mass Index will be assessed. Participants will complete the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. Participants will complete multiple questionnaires to measure Socioeconomic Status, Clinical Pain Assessment and Depression Scale. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Between Experimental Session 1 and Experimental Session 2
Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1.
Experimental Session 2
Experimental session 2 will take place in the CCTS Clinical Research Unit (CRU) All blood will be collected as part of a single draw by research nurses. Participants will complete multiple questionnaires to measure Clinical Pain Assessment and Coping Strategies. Participants will then complete a battery of ecologically valid movement tasks that include: 1) getting in and out of a bed; 2) sitting in a chair, transitioning to a standing position, and then sitting again, and 3) lifting, Performance Battery (SPPB) and the Timed Up and Go test (TUG). Blood will be processed and stored and then used to measure Vitamin D, CRP assays and Oxytocin. Finally follow up data will be collected by phone once per week for four weeks following the completion of study session 2.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| African American/Black QST | – | Other: QSTThis group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain. |
| Caucasian/White QST | – | Other: QSTThis group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and woman white Caucasian and African American with Chrionic low back pain between the ages of 19-85.
Key inclusion criteria (1 listed)
- Chronic low back pain that has been going on consistently for the last 6 months.
Key exclusion criteria (1 listed)
- Surgery (fusion, Laminectomy) in the last year, accident or trauma in the last year, uncontrolled high blood pressure, heart disease, cancer, diabetes HbA1c > 7%, Ankylosing Spondylitis, Infection, Parkinson's Disease, Multiple Sclerosis, Epilepsy, Stroke, Seizure (non-epileptic), Systemic Lupus Erythematosus, Fibromyalgia, Raynaud's disease, Major Depression/Bipolar Disorder, HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QSTAll participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour. | Other | African American/Black QST, Caucasian/White QST |
Primary outcome
Average Clinical Pain Severity
Time frame: Baseline to one week.
The Brief Pain Inventory Short-Form (BPI-SF) was used to assess clinical pain severity. Four items assessed participants' average, least, and worst pain over the past 24hours, as well as current pain (0=no pain, 10=pain as bad as you can imagine). These 4 items were averaged for a total score (range: 0-10).
13 secondary outcomes
Average Pain Threshold (Heat)
Time frame: Baseline
Average Pain Tolerance (Heat)
Time frame: Baseline
Difference in Temporal Summation of Pain (Mechanical)
Time frame: Baseline
Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation
Time frame: Baseline
Total Level of C-reactive Protein
Time frame: One week follow up
Total Level of Fibrinogen
Time frame: One week follow up
Total Level of Serum Amyloid A
Time frame: One week follow up
Total Level of Vitamin D
Time frame: One week follow up
Total Level of Oxytocin
Time frame: One week follow up
Sleep Quality
Time frame: Between baseline and one week follow-up
Self-reported Disability
Time frame: One week follow up
Evoked Pain With Movement
Time frame: One week follow up
Functional Performance
Time frame: One week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41381165Thomas PA, Ditta PV, Stocking SQ, Webb C, Meints SM, Owens MA, Quinn T, Aroke EN, Morris MC, Sorge RE, Goodin BR, Overstreet DS. The effects of neighborhood disadvantage and adverse childhood experiences on conditioned pain modulation in adults with chronic low back pain. J Pain. 2025 Dec;37S:105566. doi: 10.1016/j.jpain.2025.105566. Epub 2025 Dec 9.
- Derived from this study: PubMed 39424112Thomas PA, Ditta PV, Stocking SQ, Webb C, Meints SM, Owens MA, Quinn T, Aroke EN, Morris MC, Sorge RE, Goodin BR, Overstreet DS. The effects of neighborhood disadvantage and adverse childhood experiences on conditioned pain modulation in adults with chronic low back pain. J Pain. 2025 Jan;26:104706. doi: 10.1016/j.jpain.2024.104706. Epub 2024 Oct 16.
- Derived from this study: PubMed 38692399Thomas PA, Goodin BR, Meints SM, Owens MA, Wiggins AM, Quinn T, Long L, Aroke EN, Morris MC, Sorge RE, Overstreet DS. Adverse Childhood Experiences and Chronic Low Back Pain in Adulthood: The Role of Emotion Regulation. J Pain. 2024 Sep;25(9):104551. doi: 10.1016/j.jpain.2024.104551. Epub 2024 Apr 29.
- Derived from this study: PubMed 38323608Overstreet DS, Strath LJ, Sorge RE, Thomas PA, He J, Wiggins AM, Hobson J, Long DL, Meints SM, Aroke EN, Goodin BR. Race-specific associations: inflammatory mediators and chronic low back pain. Pain. 2024 Jul 1;165(7):1513-1522. doi: 10.1097/j.pain.0000000000003154. Epub 2024 Feb 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burel Goodin, PhD principal investigator
University of Alabama at Birmingham Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain Lower Back Chronic, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Clinical Pain Severity (time frame: Baseline to one week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03338192, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.