Lumbar Disc HerniationNCT06622356
Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up
An observational study of Lumbar Disc Herniation and Lumbar Degenerative Disease, run by Hao Liu at 1 site in China.
Trial summary
The study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes 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?
- MRI with Eovist
- How many people
- 452 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: This study retrospectively reviewed 452 patients suffering from degenerative lumbar spinedisorders in our institute between January 2019 and February 2023. The patients were separated into Recurrent pain group and Rehabilitation Group. Recurrent pain group (n = 268): mild/non pain group with VAS<3 at 12-18 months after PLIF；Rehabilitation Group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF.
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 12-18 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
Suzhou, Jiangsu, 215006
About this study
The study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes
- Being tested
- MRI with Eovist
- Keywords
- Lumbar Degenerative disease, PLIF, Sarcopenia, Sagittal balance, Machine learning, SVM, Cross Validation
- 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.
MRI with EovistOther
The study was retrospective and did not design an intervention
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Group | Rehabilitation Group (n = 268): mild/non pain group with VAS<3 at 12-18 months after PLIF。The study was retrospective and did not design an intervention Receives: Other: MRI with Eovist | |
| Recurrent pain group | Recurrent pain group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF Receives: Other: MRI with Eovist |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAS（Pain rating scale）
The visual analogue scale (VAS) was employed to determine the patient's perception of lower back pain or lower limb pain prior to surgery, as well as 12-18 months after surgery. (0-10 scale, with 0 being painless and 10 being the most painful)
Measured: 12-18 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 posted2 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
- 452 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
- NCT06622356
- Sponsor's protocol ID
- (2024) Lun Yan Grant No. 517
- Other IDs
- (2024) Lun Yan Grant No. 517
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Before January 1,2025;in the form of paper.The original data of the trial will be uploaded to Genome Sequence Archive (GSA) (ngdc.cncb.ac.cn)
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up
- ClinicalTrials.gov ID
- NCT06622356
- Acronym / sponsor ID
- (2024) Lun Yan Grant No. 517
- Keywords
- Lumbar Degenerative disease, PLIF, Sarcopenia, Sagittal balance, Machine learning, SVM, Cross Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 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
- 2 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 study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Group | – | Other: MRI with EovistRehabilitation Group (n = 268): mild/non pain group with VAS<3 at 12-18 months after PLIF。The study was retrospective and did not design an intervention |
| Recurrent pain group | – | Other: MRI with EovistRecurrent pain group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study retrospectively reviewed 452 patients suffering from degenerative lumbar spinedisorders in our institute between January 2019 and February 2023. The patients were separated into Recurrent pain group and Rehabilitation Group. Recurrent pain group (n = 268): mild/non pain group with VAS<3 at 12-18 months after PLIF；Rehabilitation Group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF.
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 12-18 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 |
|---|---|---|
| MRI with EovistThe study was retrospective and did not design an intervention | Other | Recurrent pain group, Rehabilitation Group |
Primary outcome
SAS（Pain rating scale）
Time frame: 12-18 months after surgery
The visual analogue scale (VAS) was employed to determine the patient's perception of lower back pain or lower limb pain prior to surgery, as well as 12-18 months after surgery. (0-10 scale, with 0 being painless and 10 being the most painful)
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 2 Oct 2024.
- Individual participant dataSharing planned: Yes. Before January 1,2025;in the form of paper.The original data of the trial will be uploaded to Genome Sequence Archive (GSA) (ngdc.cncb.ac.cn)
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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 2 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?
SAS（Pain rating scale） (time frame: 12-18 months after surgery). 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 2 Oct 2024.