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Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study

Racial and Socioeconomic Differences in Chronic Low Back Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03338192
Acronym
ERASED
Enrollment
281
Registered
2017-11-09
Start date
2017-10-15
Completion date
2024-01-31
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain Lower Back Chronic

Keywords

Low back pain, Chronic pain, Health disparities in chronic low back pain

Brief 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. 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.

Interventions

OTHERQST

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.

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years

Inclusion criteria

* Chronic low back pain that has been going on consistently for the last 6 months.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Average Clinical Pain SeverityBaseline 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).

Secondary

MeasureTime frameDescription
Average Pain Tolerance (Heat)BaselinePain 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.
Difference in Temporal Summation of Pain (Mechanical)BaselineTemporal 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.
Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain ModulationBaselinePressure 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.
Total Level of C-reactive ProteinOne week follow upA 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.
Total Level of FibrinogenOne week follow upFibrinogen 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.
Total Level of Serum Amyloid AOne week follow upSerum 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.
Total Level of Vitamin DOne week follow upVitamin 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.
Total Level of OxytocinOne week follow upOxytocin is a hormone that plays a crucial role in various physiological and behavioral processes, particularly in reproduction, social bonding, and emotional well-being.
Sleep QualityBetween baseline and one week follow-upInsomnia 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).
Self-reported DisabilityOne week follow upSelf-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.
Evoked Pain With MovementOne week follow upThe 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.
Functional PerformanceOne week follow upThe 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.
Average Pain Threshold (Heat)BaselinePain 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.

Other

MeasureTime frameDescription
Depressive SymptomsBaselineThe 20-item Center for Epidemiological Studies- Depression (CES-D) scale was used to measure depressive symptoms over the past week (0=rarely or none of the time \[less than 1 day\], 3=most or all of the time \[5-7days\]). All items were summed, such that higher scores suggest greater depression severity (range: 0-60).
Average Perceived Injustice (Pain-related)BaselineThe Injustice Experience Questionnaire (IEQ) was used to assess perception of pain-related injustice in this sample. Participants rated the frequency with which they experienced each of 12 thoughts/feelings when reflecting on their chronic pain condition. Items are rated on a scale of 0 (never) to 4 (all of the time). Injustice Experience Questionnaire items broadly reflect the associated factors of severity/irreparability of loss and blame/unfairness. Representative severity/irreparability items include Most people don't understand how severe my condition is, and My life will never be the same. Blame/unfairness items include I am suffering because of someone else's negligence, and It all seems so unfair. The total score was used and it ranges from 0 to 48 with higher scores representing greater perceived injustice.
Perceived DiscriminationBaselineThe Experiences of Discrimination (EOD) scale was used to assess lifetime occurrences of racial discrimination across 9 different domains (eg, at work, getting medical care). Participants rated the frequency with which they perceived experiencing discrimination in each situation (0=never, 1=once, 2.5=2-3 times, 5=4 or more times). Responses across all items were summed and higher score suggest greater perceived discrimination (range: 0-45).
Social SupportBaselineMeasured using the Multidimensional Survey of Perceived Social Support Scale (MSPSS). This scale consisted of 12 items that measure the extent of social support received from 3 specific sources: friends, family, and significant others. Types of social support assessed by the MSPSS included emotional (eg, I get the emotional help and support I need from my family), tangible (eg, There is a special person who is around when I am in need), informational (eg, My family is willing to help me make decisions), social network support (eg, I can count on my friends when things go wrong), and esteem (eg, I have a special person who is a real source of comfort to me). Each item was scored on a scale ranging from 1 (very strongly disagree) to 7 (very strongly agree). Summation of the 12 item scores provided a possible total score ranging from 12 to 84 for overall social support, with higher scores corresponding to higher levels of social support.
Total Psychological Pain ResilienceBaselineThe Pain Resilience Scale (PRS) is a 14-item assessment of resilience in the presence of intense or prolonged pain. The assessment has 2 subscales to measure specific domains of resilience: behavioral perseverance and cognitive/affective positivity. The behavioral perseverance subscale examines an individual's ability to continue engaging in behaviors or activity when experiencing pain. The cognitive/affective positivity subscale examines an individual's ability to maintain positive thoughts and manage negative thoughts or emotions while in pain. Each item is scored from 0 (not at all) to 4 (all the time) to determine the degree to which individuals engage in resiliency resources. The total Pain Resilience Scale (PRS) ranges from 0 to 56, calculated as the sum of all 14 items. Higher scores suggest greater pain resilience.
Average Dietary Caffeine ConsumptionBetween baseline and one week follow upMeasured using a daily diary of dietary intake across seven days. The value presented represents the average daily caffeine consumption.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. QST: 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.
173
Caucasian/White QST
This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain. QST: 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.
108
Total281

Withdrawals & dropouts

PeriodReasonFG000FG001
Year Four to Year SixHigh Blood Pressure21
Year One to Year TwoHigh Blood Pressure71
Year One to Year TwoHIV +10
Year Two to Year FourHigh Blood Pressure10
Year Two to Year FourHIV +20

Baseline characteristics

CharacteristicAfrican American/Black QSTCaucasian/White QSTTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
8 Participants9 Participants17 Participants
Age, Categorical
Between 18 and 65 years
165 Participants99 Participants264 Participants
Brief Pain Inventory-Short Form (BPI) pain severity scale5.1 units on a scale
STANDARD_DEVIATION 2.1
3.9 units on a scale
STANDARD_DEVIATION 1.7
4.7 units on a scale
STANDARD_DEVIATION 2.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
173 Participants0 Participants173 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants108 Participants108 Participants
Region of Enrollment
United States
173 Participants108 Participants281 Participants
Sex: Female, Male
Female
98 Participants62 Participants160 Participants
Sex: Female, Male
Male
75 Participants46 Participants121 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1730 / 108
other
Total, other adverse events
15 / 1731 / 108
serious
Total, serious adverse events
0 / 1730 / 108

Outcome results

Primary

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).

Time frame: Baseline to one week.

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTAverage Clinical Pain Severity5.1 units on a scaleStandard Deviation 2.1
Caucasian/White QSTAverage Clinical Pain Severity3.9 units on a scaleStandard Deviation 1.7
Secondary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTAverage Pain Threshold (Heat)39.96 degrees CelsiusStandard Deviation 13.87
Caucasian/White QSTAverage Pain Threshold (Heat)40.54 degrees CelsiusStandard Deviation 14.45
Secondary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTAverage Pain Tolerance (Heat)42.50 degrees CelsiusStandard Deviation 13.79
Caucasian/White QSTAverage Pain Tolerance (Heat)44.61 degrees CelsiusStandard Deviation 14.8
Secondary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTDifference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation-7.82 Difference in kiloPascals of pressureStandard Deviation 30.05
Caucasian/White QSTDifference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation-10.80 Difference in kiloPascals of pressureStandard Deviation 27.43
Secondary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTDifference in Temporal Summation of Pain (Mechanical)20.16 units on a scaleStandard Deviation 27.64
Caucasian/White QSTDifference in Temporal Summation of Pain (Mechanical)12.68 units on a scaleStandard Deviation 18.08
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTEvoked Pain With Movement31.01 units on a scaleStandard Deviation 31
Caucasian/White QSTEvoked Pain With Movement13.33 units on a scaleStandard Deviation 18.88
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTFunctional Performance8.95 units on a scaleStandard Deviation 1.81
Caucasian/White QSTFunctional Performance9.82 units on a scaleStandard Deviation 1.75
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTSelf-reported Disability53.40 units on a scaleStandard Deviation 29.49
Caucasian/White QSTSelf-reported Disability41.96 units on a scaleStandard Deviation 26.39
Secondary

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).

Time frame: Between baseline and one week follow-up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTSleep Quality12.08 units on a scaleStandard Deviation 7.1
Caucasian/White QSTSleep Quality12.12 units on a scaleStandard Deviation 7.4
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTTotal Level of C-reactive Protein6394.52 nanograms per milliliterStandard Deviation 12828.45
Caucasian/White QSTTotal Level of C-reactive Protein5040.71 nanograms per milliliterStandard Deviation 5309.51
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTTotal Level of Fibrinogen1656.55 nanograms per milliliterStandard Deviation 1052.78
Caucasian/White QSTTotal Level of Fibrinogen1417.26 nanograms per milliliterStandard Deviation 1046.08
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTTotal Level of Oxytocin181.54 nanograms per milliliterStandard Deviation 69.39
Caucasian/White QSTTotal Level of Oxytocin192.71 nanograms per milliliterStandard Deviation 87.92
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTTotal Level of Serum Amyloid A12224.88 nanograms per milliliterStandard Deviation 17436.72
Caucasian/White QSTTotal Level of Serum Amyloid A9109.35 nanograms per milliliterStandard Deviation 12349.25
Secondary

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.

Time frame: One week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTTotal Level of Vitamin D20.5 nanograms per milliliterStandard Deviation 11.1
Caucasian/White QSTTotal Level of Vitamin D26.9 nanograms per milliliterStandard Deviation 10.3
Other Pre-specified

Average Dietary Caffeine Consumption

Measured using a daily diary of dietary intake across seven days. The value presented represents the average daily caffeine consumption.

Time frame: Between baseline and one week follow up

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTAverage Dietary Caffeine Consumption165.12 milligrams per dayStandard Deviation 208.1
Caucasian/White QSTAverage Dietary Caffeine Consumption219.13 milligrams per dayStandard Deviation 208.49
Other Pre-specified

Average Perceived Injustice (Pain-related)

The Injustice Experience Questionnaire (IEQ) was used to assess perception of pain-related injustice in this sample. Participants rated the frequency with which they experienced each of 12 thoughts/feelings when reflecting on their chronic pain condition. Items are rated on a scale of 0 (never) to 4 (all of the time). Injustice Experience Questionnaire items broadly reflect the associated factors of severity/irreparability of loss and blame/unfairness. Representative severity/irreparability items include Most people don't understand how severe my condition is, and My life will never be the same. Blame/unfairness items include I am suffering because of someone else's negligence, and It all seems so unfair. The total score was used and it ranges from 0 to 48 with higher scores representing greater perceived injustice.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTAverage Perceived Injustice (Pain-related)15.69 units on a scaleStandard Deviation 12.68
Caucasian/White QSTAverage Perceived Injustice (Pain-related)13.85 units on a scaleStandard Deviation 11.5
Other Pre-specified

Depressive Symptoms

The 20-item Center for Epidemiological Studies- Depression (CES-D) scale was used to measure depressive symptoms over the past week (0=rarely or none of the time \[less than 1 day\], 3=most or all of the time \[5-7days\]). All items were summed, such that higher scores suggest greater depression severity (range: 0-60).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTDepressive Symptoms16.0 units on a scaleStandard Deviation 10
Caucasian/White QSTDepressive Symptoms17.6 units on a scaleStandard Deviation 11.8
Other Pre-specified

Perceived Discrimination

The Experiences of Discrimination (EOD) scale was used to assess lifetime occurrences of racial discrimination across 9 different domains (eg, at work, getting medical care). Participants rated the frequency with which they perceived experiencing discrimination in each situation (0=never, 1=once, 2.5=2-3 times, 5=4 or more times). Responses across all items were summed and higher score suggest greater perceived discrimination (range: 0-45).

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTPerceived Discrimination10.3 units on a scaleStandard Deviation 9.6
Caucasian/White QSTPerceived Discrimination4.1 units on a scaleStandard Deviation 8.1
Other Pre-specified

Social Support

Measured using the Multidimensional Survey of Perceived Social Support Scale (MSPSS). This scale consisted of 12 items that measure the extent of social support received from 3 specific sources: friends, family, and significant others. Types of social support assessed by the MSPSS included emotional (eg, I get the emotional help and support I need from my family), tangible (eg, There is a special person who is around when I am in need), informational (eg, My family is willing to help me make decisions), social network support (eg, I can count on my friends when things go wrong), and esteem (eg, I have a special person who is a real source of comfort to me). Each item was scored on a scale ranging from 1 (very strongly disagree) to 7 (very strongly agree). Summation of the 12 item scores provided a possible total score ranging from 12 to 84 for overall social support, with higher scores corresponding to higher levels of social support.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTSocial Support64.62 units on a scaleStandard Deviation 15.6
Caucasian/White QSTSocial Support65.88 units on a scaleStandard Deviation 15.01
Other Pre-specified

Total Psychological Pain Resilience

The Pain Resilience Scale (PRS) is a 14-item assessment of resilience in the presence of intense or prolonged pain. The assessment has 2 subscales to measure specific domains of resilience: behavioral perseverance and cognitive/affective positivity. The behavioral perseverance subscale examines an individual's ability to continue engaging in behaviors or activity when experiencing pain. The cognitive/affective positivity subscale examines an individual's ability to maintain positive thoughts and manage negative thoughts or emotions while in pain. Each item is scored from 0 (not at all) to 4 (all the time) to determine the degree to which individuals engage in resiliency resources. The total Pain Resilience Scale (PRS) ranges from 0 to 56, calculated as the sum of all 14 items. Higher scores suggest greater pain resilience.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
African American/Black QSTTotal Psychological Pain Resilience39.49 units on a scaleStandard Deviation 10.41
Caucasian/White QSTTotal Psychological Pain Resilience38.82 units on a scaleStandard Deviation 10.13

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026