A Prospective Study to Identify New "Omics" and Imaging Biomarkers of Chronic/Persistent Neck and Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Radiographic assessment
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Chronic Low Back Pain and Neck Pain
Intervention: Observation study only (Other)
Outcomes
Primary Outcomes
Radiographic assessment
Time Frame: Change up to 60-months follow-up
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
MRI assessment
Time Frame: Change up to 60-months follow-up
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.
Secondary Outcomes
- Oswestry Disability index(Change to 60-months follow-up)
- Depression-Anxiety Stress Scale(Change to 60-months follow-up)
- Cholesterol assessment(Change to 60-months follow-up)
- Neck disability index(Change to 60-months follow-up)
- VAS(Change to 60-months follow-up)
- Neck pain disability scale(Change to 60-months follow-up)
- SF-36(Change to 60-months follow-up)
- ESR(Change to 60-months follow-up)
- C-reactive protein(Change to 60-months follow-up)
Investigators
Dr. Jason Pui Yin Cheung
Clinical Associate Professor
The University of Hong Kong