NCT05976516

Brief Summary

Low back pain (LBP) is the largest cause of morbidity in the world, and about 80% of Chinese people are affected in their lifetime. Although the prevalence of IDD gradually increases with age, IDD is very common among subjects under 30 years old. In addition to age, there are other factors, such as excessive or uneven mechanical load, obesity, genetics, nutrition, trauma and gender. In addition, it is not clear whether the heavy physical load associated with occupation is an important risk factor for IDD. Some studies have found that IDD is more common among athletes than the general population. Due to the complexity and multifactorial nature of IDD, its pathogenesis and risk factors are still unclear, which seriously hinders the rational stratification of LBP patients and limits the development of personalized treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

August 4, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

February 19, 2023

Last Update Submit

July 28, 2023

Conditions

Keywords

cytokinechemokineIntervertebral Disc Degeneration

Outcome Measures

Primary Outcomes (1)

  • CXCL2/8 content

    CXCL2/CXCL8 content of nucleus pulposus

    1 month

Study Arms (4)

pirffmann 2 grade

Diagnostic Test: CXCL2/CXCL8

pirffmann 3 grade

Diagnostic Test: CXCL2/CXCL8

pirffmann 4 grade

Diagnostic Test: CXCL2/CXCL8

pirffmann 5 grade

Diagnostic Test: CXCL2/CXCL8

Interventions

CXCL2/CXCL8DIAGNOSTIC_TEST

Detecte CXCL2/8 content in nucleus pulposus and peripheral blood of patients in each group

pirffmann 2 gradepirffmann 3 gradepirffmann 4 gradepirffmann 5 grade

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with lumbar disc herniation who went to the spinal surgery department of Zhongda Hospital

You may qualify if:

  • It meets the diagnostic criteria of lumbar disc degeneration; No previous history of spinal surgery; Good ability of independent behavior and cooperation in completing research; The patient is aware of this study and has signed the consent form.

You may not qualify if:

  • Patients with spinal tumor, infection, tuberculosis and other diseases; Patients with claustrophobia; Parkinson's syndrome patients; Poor cooperation, Poor image quality; Patients with osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 19, 2023

First Posted

August 4, 2023

Study Start

August 1, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

August 4, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations