Chronic Low Back Pain and Neck Pain Prospective Study

Active, not recruiting

• Conditions: Chronic Neck Pain; Chronic Low Back Pain
• Interventions: Other: Observation study only

• Registration Number: NCT04883476
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Low Back Pain and Neck Pain	Observation study only	-

Primary Outcome Measures

Name	Time	Method
Radiographic assessment	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	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 Outcome Measures

Name	Time	Method
Oswestry Disability index	Change to 60-months follow-up	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.
Depression-Anxiety Stress Scale	Change to 60-months follow-up	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.
Cholesterol assessment	Change to 60-months follow-up	low density lipoprotein (LDL), high density lipoprotein (HDL), cholesterol counts, triglycerides
Neck disability index	Change to 60-months follow-up	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.
VAS	Change to 60-months follow-up	Questionnaire assessment for pain score. 0-10 with 10 being most severe.
Neck pain disability scale	Change to 60-months follow-up	Questionnaire assessment: NPAD is a composite score of 20 items. Each score ranges from 0-5 with maximum score of 100 indicating maximal pain.
SF-36	Change to 60-months follow-up	Questionnaire assessment: eight scaled score with weighted sums. Transformed to 0-100 scale, lower score means more disability.
ESR	Change to 60-months follow-up	Inflammatory marker via blood test
C-reactive protein	Change to 60-months follow-up	Inflammatory marker via blood test

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong