Chronic Low Back Pain and Neck Pain Prospective Study

NCT04883476 | Completed

• 1 other identifier: Study Protocol v. 1.0
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observation multifaceted study aims:

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

Conditions

Chronic Low Back Pain; Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Oswestry Disability index

  Change to 60-months follow-up

• Neck disability index

  Change to 60-months follow-up

• Neck pain disability scale

  Change to 60-months follow-up

• Depression-Anxiety Stress Scale

  Change to 60-months follow-up

• SF-36

  Change to 60-months follow-up

Study Arms (1)

Chronic Low Back Pain and Neck Pain

Other: Observation study only

Interventions

Observation study only OTHER

Chronic Low Back Pain and Neck Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were referred to the specialist orthopaedic clinic

You may qualify if:

• Neck and/or low back pain
• New cases\*
• Males and females
• years or older
• Willing to participate in the study short- and long-term

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

Study Officials

• Dr. Jason Cheung

  The University of Hong Kong/ Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 12, 2021
• Study Start: May 1, 2015
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

HK (1)