Chronic Low Back Pain and Neck Pain Prospective Study

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04883476
• Other study ID #: Study Protocol v. 1.0
• Status: Active, not recruiting
• Start date: May 1, 2015
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Neck Pain
• Low Back Pain
• Neck Pain

Intervention

Other:
• Observation study only

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	VAS	Questionnaire assessment for pain score. 0-10 with 10 being most severe.	Change to 60-months follow-up
Secondary	Cholesterol assessment	low density lipoprotein (LDL), high density lipoprotein (HDL), cholesterol counts, triglycerides	Change to 60-months follow-up
Secondary	ESR	Inflammatory marker via blood test	Change to 60-months follow-up
Secondary	C-reactive protein	Inflammatory marker via blood test	Change to 60-months follow-up