MedDataX Logo

Chronic Low Back Pain and Neck Pain Prospective Study

NCT ID: NCT04883476

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Low Back Pain Chronic Neck Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chronic Low Back Pain and Neck Pain

Observation study only

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observation study only

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Jason Pui Yin Cheung

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Jason Cheung

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong/ Queen Mary Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Study Protocol v. 1.0

Identifier Type: -

Identifier Source: org_study_id