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Completed

NCT Number: NCT04883476

Chronic Low Back Pain and Neck Pain Prospective Study

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.

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Key information

Conditions

Chronic Low Back Pain Chronic Neck Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation study only

Other

Primary outcomes

  1. 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

  2. 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

  1. Oswestry Disability index

    Time frame: 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.

  2. Neck disability index

    Time frame: 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.

  3. Neck pain disability scale

    Time frame: 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.

  4. Depression-Anxiety Stress Scale

    Time frame: 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.

  5. SF-36

    Time frame: Change to 60-months follow-up

    Questionnaire assessment: eight scaled score with weighted sums. Transformed to 0-100 scale, lower score means more disability.

  6. VAS

    Time frame: Change to 60-months follow-up

    Questionnaire assessment for pain score. 0-10 with 10 being most severe.

  7. Cholesterol assessment

    Time frame: Change to 60-months follow-up

    low density lipoprotein (LDL), high density lipoprotein (HDL), cholesterol counts, triglycerides

  8. ESR

    Time frame: Change to 60-months follow-up

    Inflammatory marker via blood test

  9. C-reactive protein

    Time frame: Change to 60-months follow-up

    Inflammatory marker via blood test

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
May 12, 2021
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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