Lumbar Disc HerniationNCT06628583
Multivariate Analysis and Risk Factors Were Used to Predict the Short-term Postoperative Pain of Degenerative Lumbar Spine
An observational study of Lumbar Disc Herniation and Lumbar Degenerative Disease, run by Hao Liu at 1 site in China.
Trial summary
The objective of this retrospective clinical study wasto study the risk factors for short-term low back and leg pain after PLIF in patients with lumbar Degenerative disease, and to establish a risk prediction model for short-term low back and leg pain after PLIF based on relevant risk factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Degenerative Disease, Sarcopenia
- What is being tested?
- Magnetic Resonance Imaging with Contrast
- How many people
- 936 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 28 Sep 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The data of 936 patients who underwent PLIF for lumbar Degenerative disease from June 2018 to March 2023 were collected retrospectively. The patients were divided into rehabilitation group（N=501） and residual pain group（N=435）according to their postoperative pain
Who may be able to join
- confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
- lumbar spinal fusion surgical treatment with PLIF;
- grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 3th month postoperative follow-up;
- observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.
Who cannot join
- those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site
Medical record system and imaging system of the First Affiliated Hospital of Suzhou University, China
Suzhou, Jiangsu, 215006
About this study
The objective of this retrospective clinical study wasto study the risk factors for short-term low back and leg pain after PLIF in patients with lumbar Degenerative disease, and to establish a risk prediction model for short-term low back and leg pain after PLIF based on relevant risk factors.
- Being tested
- Magnetic Resonance Imaging with Contrast
- Keywords
- Lumbar Degenerative disease, PLIF, Sarcopenia, Sagittal bit balance, Machine learning
- Medical subject headings
- Intervertebral Disc Displacement, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging with ContrastOther
The study was retrospective and did not set interventions
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Group | mild/non pain group with VAS<3 at 3th months after PLIF.N=501 Receives: Other: Magnetic Resonance Imaging with Contrast | |
| Recurrent pain group | Recurrent pain group: recurrent pain group with VAS≥3 at 3th months after PLIF.N=435 Receives: Other: Magnetic Resonance Imaging with Contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
General situation of the patient
General information such as age, sex, BMI and psychological status was collected
Measured: Before the operation
Secondary outcomes (1)
Surgical situation
It includes the course of disease, the operation time, the amount of bone cement injected during the operation, the leakage of bone cement and so on
Measured: 1-3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start20 Sep 2024
- Primary completion25 Sep 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hao Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hao Liu, First Affiliated Hospital of Suzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628583
- Sponsor's protocol ID
- (2024) Lun Yan Grant No. 518
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariate Analysis and Risk Factors Were Used to Predict the Short-term Postoperative Pain of Degenerative Lumbar Spine
- ClinicalTrials.gov ID
- NCT06628583
- Acronym / sponsor ID
- (2024) Lun Yan Grant No. 518
- Keywords
- Lumbar Degenerative disease, PLIF, Sarcopenia, Sagittal bit balance, Machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 936 participants (actual)
- Lead sponsor
- Hao LiuUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 8 Oct 2024 (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.
The objective of this retrospective clinical study wasto study the risk factors for short-term low back and leg pain after PLIF in patients with lumbar Degenerative disease, and to establish a risk prediction model for short-term low back and leg pain after PLIF based on relevant risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Group | – | Other: Magnetic Resonance Imaging with Contrastmild/non pain group with VAS<3 at 3th months after PLIF.N=501 |
| Recurrent pain group | – | Other: Magnetic Resonance Imaging with ContrastRecurrent pain group: recurrent pain group with VAS≥3 at 3th months after PLIF.N=435 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The data of 936 patients who underwent PLIF for lumbar Degenerative disease from June 2018 to March 2023 were collected retrospectively. The patients were divided into rehabilitation group（N=501） and residual pain group（N=435）according to their postoperative pain
Key inclusion criteria (4 listed)
- confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
- lumbar spinal fusion surgical treatment with PLIF;
- grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 3th month postoperative follow-up;
- observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.
Key exclusion criteria (1 listed)
- those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.
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 |
|---|---|---|
| Magnetic Resonance Imaging with ContrastThe study was retrospective and did not set interventions | Other | Recurrent pain group, Rehabilitation Group |
Primary outcome
General situation of the patient
Time frame: Before the operation
General information such as age, sex, BMI and psychological status was collected
1 secondary outcome
Surgical situation
Time frame: 1-3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lumbar Disc Herniation and Lumbar Degenerative Disease, run by Hao Liu 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 4 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: finished, as of the sponsor's last update on 8 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General situation of the patient (time frame: Before the operation). 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 8 Oct 2024.