Chronic Low Back Pain and Neck Pain Prospective Study

Study Overview
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Brief Summary
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This prospective observation multifaceted study aims: To perform a large prospective study and identify multiple omics biomarkers in chronic low back pain To validate identified biomarkers for progression of acute to chronic low back pain To validate identified biomarkers and test their heritability/validity in additional cohorts To identify pathways and relevant individual variations for generation, propagation and subsidence of pain To identify new imaging biomarkers related to chronic low back pain To develop a registry of neck and low back pain subjects to help monitor the health-care management and utility to improve protocols and patient outcomes.

Detailed Description
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This novel study aims to identify genetic variants associated with chronic low back pain as well as omics and imaging biomarkers. To achieve this, we will link and relate clinical data (clinical and neurological signs leading to anatomical diagnosis plus a careful evaluation of inflammatory response of patient) to a multiple omics analysis in order to investigate promising biomarkers that could answer unmet needs: identification of predisposition to develop chronic low back pain, diagnosis and an objective measure of pain intensity in order to correlate to its pathophysiology, and validate predictors of response to specific (drug) treatments.

Official Title
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A Prospective Study to Identify New Omics and Imaging Biomarkers of Chronic/Persistent Neck and Low Back Pain

Conditions
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Chronic Low Back Pain, Chronic Neck Pain

Intervention / Treatment
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* Other: Observation study only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neck and/or low back pain New cases* Males and females 18 years or older Willing to participate in the study short- and long-term Exclusion Criteria: Previous spine surgery Cognitively impaired Drug addiction Incarceration (prisoner) History of infections, tumors, chronic inflammation (e.g. rheumatoid arthritis, ankylosing spondylitis) Congenital/syndromal Pregnant females Diagnosed psychological impairment Inability to read or write

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Low Back Pain and Neck Pain<br> | Other: Observation study only<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic assessment | assess the subjects' standing X-ray of the whole spine (AP and lateral) for the presence and extent of atherosclerosis, endplate thickening (sclerosis), vertebral osteophytes, limbus vertebrae, presence and categorization of vertebral subluxation (spondylolisthesis), additional spine-related deformities, spinal canal and vertebral body/foraminal dimensions, and static/dynamic spinal motion parameters and alignments. This will be done at interval follow-ups | Change up to 60-months follow-up | 
| MRI assessment | MRI: Sagittal T2W MRI whole spine and axial T1W MRI of lumbar spine will be assessed in all subjects. The radiographic events/outcomes of interest entailed the presence and extent of disc degeneration, disc bulges/herniations, Schmorl's nodes (endplate irregularities), high-intensity zones (HIZ), and bone marrow signal changes involving the endplate. Interval assessments will be made. | Change up to 60-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability index | Questionnaire assessment: ODI is based on a 0-5 scale with 5 representing greatest disability. The index is calculated by dividing the summed score by the total possible score then multiplied by 100 as a percentage. | Change to 60-months follow-up | 
| Neck disability index | Questionnaire assessment: NDI assesses neck pain related disability. There are 10 items scored from 0-5 with maximum score of 50 indicating most severe pain. | Change to 60-months follow-up | 
| Neck pain disability scale | Questionnaire assessment: NPAD is a composite score of 20 items. Each score ranges from 0-5 with maximum score of 100 indicating maximal pain. | Change to 60-months follow-up | 
| Depression-Anxiety Stress Scale | Questionnaire assessment: DASS assesses symptoms based on a 4-point scale with subscales for depression, anxiety and stress. A range of 0-42 can be used with a higher score indicating worse severity. | Change to 60-months follow-up | 
| SF-36 | Questionnaire assessment: eight scaled score with weighted sums. Transformed to 0-100 scale, lower score means more disability. | Change to 60-months follow-up | 
| VAS | Questionnaire assessment for pain score. 0-10 with 10 being most severe. | Change to 60-months follow-up | 
| Cholesterol assessment | low density lipoprotein (LDL), high density lipoprotein (HDL), cholesterol counts, triglycerides | Change to 60-months follow-up | 
| ESR | Inflammatory marker via blood test | Change to 60-months follow-up | 
| C-reactive protein | Inflammatory marker via blood test | Change to 60-months follow-up |