Clinical trial NCT04883476: Chronic Low Back Pain and Neck Pain Prospective Study
Official title: A Prospective Study to Identify New "Omics" and Imaging Biomarkers of Chronic/Persistent Neck and Low Back Pain
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Low Back Pain
Chronic Neck Pain
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were referred to the specialist orthopaedic clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiographic assessment
timeFrame: Change up to 60-months follow-up
measure: MRI assessment
timeFrame: Change up to 60-months follow-up
Secondary outcomes:
measure: Oswestry Disability index
timeFrame: Change to 60-months follow-up
measure: Neck disability index
timeFrame: Change to 60-months follow-up
measure: Neck pain disability scale
timeFrame: Change to 60-months follow-up
measure: Depression-Anxiety Stress Scale
timeFrame: Change to 60-months follow-up
measure: SF-36
timeFrame: Change to 60-months follow-up
measure: VAS
timeFrame: Change to 60-months follow-up
measure: Cholesterol assessment
timeFrame: Change to 60-months follow-up
measure: ESR
timeFrame: Change to 60-months follow-up
measure: C-reactive protein
timeFrame: Change to 60-months follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong/ Queen Mary Hospital
name: Dr. Jason Cheung
role: PRINCIPAL_INVESTIGATOR
References: