Chronic Low Back Pain and Neck Pain Prospective Study

N/AActive Not RecruitingNCT04883476

The University of Hong Kong800 enrolled

Overview

This prospective observation multifaceted study aims: 1. To perform a large prospective study and identify multiple "omics" biomarkers in chronic low back pain 2. To validate identified biomarkers for progression of acute to chronic low back pain 3. To validate identified biomarkers and test their heritability/validity in additional cohorts 4. To identify pathways and relevant individual variations for generation, propagation and subsidence of pain 5. To identify new imaging biomarkers related to chronic low back pain 6. 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.

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Chronic Low Back Pain Chronic Neck Pain

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Change up to 60-months follow-up

Secondary Outcomes

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.