Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-04 @ 6:58 PM
Study NCT ID:
NCT03338192
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2017-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'burel@wustl.edu', 'phone': '3142736403', 'title': 'Burel Goodin', 'organization': 'Washington University Pain Center in St. Louis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to a delay in the initial award notification, start up was delayed in the first year. Recruitment increased and the protocol infrastructure was complete when the Covid 19 pandemic stopped all protocol recruitment and all study tasks. After the pandemic, recruitment was slower, the study timeline indicated recruitment completion at the end of 2022, but we had to request a No Cost Extension from January 2022 to January 2023 to complete recruitment numbers.'}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'We had no adverse events linked to this protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 15, 'seriousNumAtRisk': 173, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 1, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'High Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HIV +', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Clinical Pain Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to one week.', 'description': "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).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Pain Threshold (Heat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.96', 'spread': '13.87', 'groupId': 'OG000'}, {'value': '40.54', 'spread': '14.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Pain Tolerance (Heat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.50', 'spread': '13.79', 'groupId': 'OG000'}, {'value': '44.61', 'spread': '14.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Temporal Summation of Pain (Mechanical)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.16', 'spread': '27.64', 'groupId': 'OG000'}, {'value': '12.68', 'spread': '18.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.82', 'spread': '30.05', 'groupId': 'OG000'}, {'value': '-10.80', 'spread': '27.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'Difference in kiloPascals of pressure', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Level of C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '6394.52', 'spread': '12828.45', 'groupId': 'OG000'}, {'value': '5040.71', 'spread': '5309.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': '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.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Level of Fibrinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1656.55', 'spread': '1052.78', 'groupId': 'OG000'}, {'value': '1417.26', 'spread': '1046.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': '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.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Level of Serum Amyloid A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '12224.88', 'spread': '17436.72', 'groupId': 'OG000'}, {'value': '9109.35', 'spread': '12349.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': '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.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Level of Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': '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.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Level of Oxytocin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '181.54', 'spread': '69.39', 'groupId': 'OG000'}, {'value': '192.71', 'spread': '87.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': 'Oxytocin is a hormone that plays a crucial role in various physiological and behavioral processes, particularly in reproduction, social bonding, and emotional well-being.', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.08', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '12.12', 'spread': '7.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and one week follow-up', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.40', 'spread': '29.49', 'groupId': 'OG000'}, {'value': '41.96', 'spread': '26.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evoked Pain With Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.01', 'spread': '31.00', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '18.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.95', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '9.82', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One week follow up', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depressive Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Perceived Injustice (Pain-related)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.69', 'spread': '12.68', 'groupId': 'OG000'}, {'value': '13.85', 'spread': '11.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Discrimination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.62', 'spread': '15.60', 'groupId': 'OG000'}, {'value': '65.88', 'spread': '15.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Psychological Pain Resilience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.49', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '38.82', 'spread': '10.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Dietary Caffeine Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'OG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '165.12', 'spread': '208.10', 'groupId': 'OG000'}, {'value': '219.13', 'spread': '208.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and one week follow up', 'description': 'Measured using a daily diary of dietary intake across seven days. The value presented represents the average daily caffeine consumption.', 'unitOfMeasure': 'milligrams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'FG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}], 'periods': [{'title': 'Year One to Year Two', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'High Blood Pressure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'HIV +', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Year Two to Year Four', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'High Blood Pressure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'HIV +', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Year Four to Year Six', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'High Blood Pressure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'BG001', 'title': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.\n\nQST: 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Brief Pain Inventory-Short Form (BPI) pain severity scale', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The BPI pain severity outcome is comprised of four items that assess 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).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-18', 'size': 593509, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-04T16:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Specimens will be labeled with unique identifiers (subject numbers) that correspond to each separate participant. Blood samples will be processed for serum and plasma and stored at -80 and then used to detect levels of Vitamin D, C-reactive protein and Oxytocin.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2017-11-07', 'resultsFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2017-11-08', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-11', 'studyFirstPostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Average Perceived Injustice (Pain-related)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Perceived Discrimination', 'timeFrame': 'Baseline', 'description': '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).'}, {'measure': 'Social Support', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Total Psychological Pain Resilience', 'timeFrame': 'Baseline', 'description': "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."}, {'measure': 'Average Dietary Caffeine Consumption', 'timeFrame': 'Between baseline and one week follow up', 'description': 'Measured using a daily diary of dietary intake across seven days. The value presented represents the average daily caffeine consumption.'}], 'primaryOutcomes': [{'measure': 'Average Clinical Pain Severity', 'timeFrame': 'Baseline to one week.', 'description': "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)."}], 'secondaryOutcomes': [{'measure': 'Average Pain Threshold (Heat)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Average Pain Tolerance (Heat)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Difference in Temporal Summation of Pain (Mechanical)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Difference in Pressure Pain Thresholds Assessed Using Conditioned Pain Modulation', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Total Level of C-reactive Protein', 'timeFrame': 'One week follow up', 'description': '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.'}, {'measure': 'Total Level of Fibrinogen', 'timeFrame': 'One week follow up', 'description': '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.'}, {'measure': 'Total Level of Serum Amyloid A', 'timeFrame': 'One week follow up', 'description': '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.'}, {'measure': 'Total Level of Vitamin D', 'timeFrame': 'One week follow up', 'description': '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.'}, {'measure': 'Total Level of Oxytocin', 'timeFrame': 'One week follow up', 'description': 'Oxytocin is a hormone that plays a crucial role in various physiological and behavioral processes, particularly in reproduction, social bonding, and emotional well-being.'}, {'measure': 'Sleep Quality', 'timeFrame': 'Between baseline and one week follow-up', 'description': '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).'}, {'measure': 'Self-reported Disability', 'timeFrame': 'One week follow up', 'description': '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.'}, {'measure': 'Evoked Pain With Movement', 'timeFrame': 'One week follow up', 'description': '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.'}, {'measure': 'Functional Performance', 'timeFrame': 'One week follow up', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Chronic pain', 'Health disparities in chronic low back pain'], 'conditions': ['Back Pain Lower Back Chronic']}, 'referencesModule': {'references': [{'pmid': '41381165', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39424112', 'type': 'DERIVED', 'citation': '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 Jan;26:104706. doi: 10.1016/j.jpain.2024.104706. Epub 2024 Oct 16.'}, {'pmid': '38692399', 'type': 'DERIVED', 'citation': 'Thomas 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.'}, {'pmid': '38323608', 'type': 'DERIVED', 'citation': 'Overstreet 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Experimental session 1\n\nResting 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.\n\nBetween Experimental Session 1 and Experimental Session 2\n\nSleep 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.\n\nExperimental Session 2\n\nExperimental 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '19 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and woman white Caucasian and African American with Chrionic low back pain between the ages of 19-85.', 'genderDescription': 'Biological gender of either male or female.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic low back pain that has been going on consistently for the last 6 months.\n\nExclusion Criteria:\n\n* 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"}, 'identificationModule': {'nctId': 'NCT03338192', 'acronym': 'ERASED', 'briefTitle': 'Examining Racial and SocioEconomic Disparities (ERASED) in Chronic Low Back Pain Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Racial and Socioeconomic Differences in Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'F170119003'}, 'secondaryIdInfos': [{'id': 'R01MD010441', 'link': 'https://reporter.nih.gov/quickSearch/R01MD010441', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'African American/Black QST', 'description': 'This group will consist of a full range of socioeconomic status in African American/Black individuals with chronic low back pain.', 'interventionNames': ['Other: QST']}, {'label': 'Caucasian/White QST', 'description': 'This group will consist of a full range of socioeconomic status in Caucasian/White individuals with chronic low back pain.', 'interventionNames': ['Other: QST']}], 'interventions': [{'name': 'QST', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['African American/Black QST', 'Caucasian/White QST']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Burel Goodin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham Department of Psychology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Burel Goodin', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}