Chronic Low Back PainNCT04883476
Chronic Low Back Pain and Neck Pain Prospective Study
An observational study of Chronic Low Back Pain and Chronic Neck Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain, Chronic Neck Pain
- What is being tested?
- Observation study only
- How many people
- 800 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2015to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were referred to the specialist orthopaedic clinic
Who may be able to join
- 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
Who cannot join
- Previous spine surgery
- Cognitively impaired
- Drug addiction
- Incarceration (prisoner)
- History of infections, tumors, chronic inflammation (e.g. rheumatoid arthritis, ankylosing spondylitis)
- Congenital/syndromal
Show all 9Show fewer
- Pregnant females
- Diagnosed psychological impairment
- Inability to read or write
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Identify New "Omics" and Imaging Biomarkers of Chronic/Persistent Neck and Low Back Pain
This prospective observation multifaceted study aims:
- To perform a large prospective study and identify multiple "omics" biomarkers in chronic low back pain
- To validate identified biomarkers for progression of acute to chronic low back pain
- To validate identified biomarkers and test their heritability/validity in additional cohorts
- To identify pathways and relevant individual variations for generation, propagation and subsidence of pain
- To identify new imaging biomarkers related to chronic low back pain
- 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.
Read the 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.
- Conditions
- Chronic Low Back Pain, Chronic Neck Pain
- Being tested
- Observation study only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation study onlyOther
| Study group | Role | What they receive |
|---|---|---|
| Chronic Low Back Pain and Neck Pain | Not described Receives: Other: Observation study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Change up to 60-months follow-up
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change to 60-months follow-up
VAS
Questionnaire assessment for pain score. 0-10 with 10 being most severe.
Measured: Change to 60-months follow-up
Cholesterol assessment
low density lipoprotein (LDL), high density lipoprotein (HDL), cholesterol counts, triglycerides
Measured: Change to 60-months follow-up
ESR
Inflammatory marker via blood test
Measured: Change to 60-months follow-up
C-reactive protein
Inflammatory marker via blood test
Measured: Change to 60-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start1 May 2015
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jason Pui Yin Cheung, The University of Hong Kong
- Investigators
- Dr. Jason Cheung, Principal investigator, The University of Hong Kong/ Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883476
- Sponsor's protocol ID
- Study Protocol v. 1.0
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Identify New "Omics" and Imaging Biomarkers of Chronic/Persistent Neck and Low Back Pain
- ClinicalTrials.gov ID
- NCT04883476
- Acronym / sponsor ID
- Study Protocol v. 1.0
- Conditions
- Chronic Low Back Pain, Chronic Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observation multifaceted study aims:
- To perform a large prospective study and identify multiple "omics" biomarkers in chronic low back pain
- To validate identified biomarkers for progression of acute to chronic low back pain
- To validate identified biomarkers and test their heritability/validity in additional cohorts
- To identify pathways and relevant individual variations for generation, propagation and subsidence of pain
- To identify new imaging biomarkers related to chronic low back pain
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Low Back Pain and Neck Pain | – | Other: Observation study only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were referred to the specialist orthopaedic clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Previous spine surgery
- Cognitively impaired
- Drug addiction
- Incarceration (prisoner)
- History of infections, tumors, chronic inflammation (e.g. rheumatoid arthritis, ankylosing spondylitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation study only | Other | Chronic Low Back Pain and Neck Pain |
Primary outcome
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
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.
9 secondary outcomes
Oswestry Disability index
Time frame: Change to 60-months follow-up
Neck disability index
Time frame: Change to 60-months follow-up
Neck pain disability scale
Time frame: Change to 60-months follow-up
Depression-Anxiety Stress Scale
Time frame: Change to 60-months follow-up
SF-36
Time frame: Change to 60-months follow-up
VAS
Time frame: Change to 60-months follow-up
Cholesterol assessment
Time frame: Change to 60-months follow-up
ESR
Time frame: Change to 60-months follow-up
C-reactive protein
Time frame: Change to 60-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Jason Cheung principal investigator
The University of Hong Kong/ Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain and Chronic Neck Pain, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessment (time frame: Change up to 60-months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.