Chronic Low Back Pain and Neck Pain Prospective Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Low Back Pain; Chronic Neck Pain
• Intervention / Treatment: Other: Observation study only

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients were referred to the specialist orthopaedic clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Low Back Pain and Neck Pain	Other: Observation study only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Dr. Jason Cheung, The University of Hong Kong/ Queen Mary Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Neck Pain
• Other Study ID Numbers: Study Protocol v. 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No