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This prospective observation multifaceted study aims:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Low Back Pain and Neck Pain |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation study only | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients were referred to the specialist orthopaedic clinic
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Jason Cheung | The University of Hong Kong/ Queen Mary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
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Tests for low density lipoprotein (LDL), high density lipoprotein (HDL), cholesterol counts, triglycerides, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), metabolomics, glycomics, CCL5/CCL6 and adipokines.
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 |