CytokineNCT05976516
CXCL2/CXCL8 Promote Intervertebral Disc Degeneration
An observational study of Cytokine and Intervertebral Disc, Degenerative, run by Zhongda Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cytokine, Intervertebral Disc, Degenerative
- What is being tested?
- CXCL2/CXCL8
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 30 Mar 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with lumbar disc herniation who went to the spinal surgery department of Zhongda Hospital
Who may be able to join
- 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.
Who cannot join
- Patients with spinal tumor, infection, tuberculosis and other diseases; Patients with claustrophobia; Parkinson's syndrome patients; Poor cooperation, Poor image quality; Patients with osteoporosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu
Lei liu, Dr, 18934544893, 18934544893@163.com
About this study
Official title: Study on the Correlation Between CXCL2/CXCL8 and the Degree of Intervertebral Disc Degeneration and Radiological Progress
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.
- Conditions
- Cytokine, Intervertebral Disc, Degenerative
- Being tested
- CXCL2/CXCL8
- Keywords
- cytokine, chemokine, Intervertebral Disc Degeneration
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCL2/CXCL8Diagnostic test
Detecte CXCL2/8 content in nucleus pulposus and peripheral blood of patients in each group
| Study group | Role | What they receive |
|---|---|---|
| pirffmann 2 grade | Not described Receives: Diagnostic Test: CXCL2/CXCL8 | |
| pirffmann 3 grade | Not described Receives: Diagnostic Test: CXCL2/CXCL8 | |
| pirffmann 4 grade | Not described Receives: Diagnostic Test: CXCL2/CXCL8 | |
| pirffmann 5 grade | Not described Receives: Diagnostic Test: CXCL2/CXCL8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CXCL2/8 content
CXCL2/CXCL8 content of nucleus pulposus
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytokineStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, pengfei, xue, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976516
- Sponsor's protocol ID
- 20220224016
- Status last verified
- Jul 2023
- First submitted
- 19 Feb 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between CXCL2/CXCL8 and the Degree of Intervertebral Disc Degeneration and Radiological Progress
- ClinicalTrials.gov ID
- NCT05976516
- Acronym / sponsor ID
- 20220224016
- Conditions
- Cytokine, Intervertebral Disc, Degenerative
- Keywords
- cytokine, chemokine, Intervertebral Disc Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 4 Aug 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with lumbar disc herniation who went to the spinal surgery department of Zhongda Hospital
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with spinal tumor, infection, tuberculosis and other diseases; Patients with claustrophobia; Parkinson's syndrome patients; Poor cooperation, Poor image quality; Patients with osteoporosis.
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 |
|---|---|---|
| CXCL2/CXCL8Detecte CXCL2/8 content in nucleus pulposus and peripheral blood of patients in each group | Diagnostic test | pirffmann 2 grade, pirffmann 3 grade, pirffmann 4 grade, pirffmann 5 grade |
Primary outcome
CXCL2/8 content
Time frame: 1 month
CXCL2/CXCL8 content of nucleus pulposus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: No
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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.
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 Cytokine and Intervertebral Disc, Degenerative, run by Zhongda Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Aug 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CXCL2/8 content (time frame: 1 month). 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 4 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.