Examining Racial & SocioEconomic Disparities (ERASED) in Chronic Low Back

Status Completed

Clinical Trial Summary

It remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (cLBP) outcomes. The overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in cLBP severity and disability. 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.

Clinical Trial Description

Experimental session 1 Resting Blood Pressure and Body Mass Index will be assessed. Participants will complete the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. Participants will complete multiple questionnaires to measure Socioeconomic Status, Clinical Pain Assessment and Depression Scale. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour. Between Experimental Session 1 and Experimental Session 2 Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1. Experimental Session 2 Experimental session 2 will take place in the CCTS Clinical Research Unit (CRU) All blood will be collected as part of a single draw by research nurses. Participants will complete multiple questionnaires to measure Clinical Pain Assessment and Coping Strategies. Participants will then complete a battery of ecologically valid movement tasks that include: 1) getting in and out of a bed; 2) sitting in a chair, transitioning to a standing position, and then sitting again, and 3) lifting, Performance Battery (SPPB) and the Timed Up and Go test (TUG). Blood will be processed and stored and then used to measure Vitamin D, CRP assays and Oxytocin. Finally follow up data will be collected by phone once per week for four weeks following the completion of study session 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03338192
Study type	Observational
Source	University of Alabama at Birmingham
Contact
Status	Completed
Phase
Start date	October 15, 2017
Completion date	January 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01914666` - An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain	Phase 3
Completed	`NCT01761617` - Yoga Dosing Study for Chronic Low Back Pain	N/A
Completed	`NCT03106740` - Evaluating the Role of Neuroinflammation in Low Back Pain	Phase 2
Completed	`NCT02960269` - Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing	N/A
Completed	`NCT04203888` - Personalized Trial for Chronic Lower Back Pain	N/A
Not yet recruiting	`NCT05704751` - EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients
Completed	`NCT06351774` - Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain	N/A
Terminated	`NCT01865539` - Efficacy of Foot Orthotics in Veterans With Chronic Lower Back Pain	N/A
Completed	`NCT01855919` - A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain	Phase 3
Enrolling by invitation	`NCT05386212` - The Impact of an Instructional Web-based Healthcare App for Relieving Back Pain From Spinal Compression Fractures
Completed	`NCT03299192` - Tai Chi for Chronic Low Back Pain in Older Adults	N/A
Completed	`NCT01081912` - Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain	Phase 3
Completed	`NCT04468074` - Virtual Reality Treatment for Adults With Chronic Back Pain	N/A
Completed	`NCT01343927` - Yoga vs. Physical Therapy vs. Education for Chronic Low Back Pain in Minority Populations	N/A
Completed	`NCT01329861` - Internet-based Cognitive Behavioural Treatment for Chronic Back Pain	N/A
Terminated	`NCT01125917` - Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015	Phase 3
Enrolling by invitation	`NCT05413070` - Quality Improvement re: Choosing Wisely Back Pain Measures
Not yet recruiting	`NCT06401499` - The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination	Phase 4
Recruiting	`NCT04893720` - The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration
Recruiting	`NCT05953155` - YOga for Patients With Chronic BACK Pain and Poor PROgnosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms