Lumbar Disc HerniationNCT05772143
Percutaneous Discectomy to Treat Symptomatic Lumbar Disc Herniation : Evaluation of Clinical Efficiency, Patient Reported Outcomes and Economical Impact by Assessing Time Before Return to Work and Duration of Hospitalization Stay
An observational study of Lumbar Disc Herniation, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
This study aims to evaluate the clinical (pain) and functional (patient reported outcomes) efficacy of percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- Percutaneous discectomies under CT
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 31 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient over 18 years of age suffering from radiculalgia related to lumbar disc herniation visualized on MRI with radio-clinical concordance, failure of conservative treatment and nerve root infiltrations ; consulting in interventionnal radiology care unit,
Who may be able to join
- radiculalgia related to lumbar disc herniation with clinical radiological concordance
- age > 18
- resistance to conservative treatment and nerve root infiltrations
Who cannot join
- prior discal surgery at the same level,
- lumbar canal stenosis,
- extruded discal herniation,
- neurological deficit,
- no capacity to answer to follow-up calls
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Lumbar Discectomy : Evaluation of Patient Reported Outcomes, Aconomical Impact and Return to Work
This study aims to evaluate the clinical (pain) and functional (patient reported outcomes) efficacy of percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.
The aim is also to evaluate the economic impact of the procedure, mainly through the length of hospitalization and the time to return to work.
Patients were evaluated initially before surgery and then at 1, 3 and 6 months.
- Conditions
- Lumbar Disc Herniation
- Being tested
- Percutaneous discectomies under CT
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous discectomies under CTProcedure or surgery
Percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar disc herniation | Patient over 18 years of age suffering from radiculalgia related to lumbar disc herniation visualized on MRI with radio-clinical concordance, failure of conservative treatment and nerve root infiltrations Receives: Procedure: Percutaneous discectomies under CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
Measured: before treatment
Oswestry disability index
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
Measured: At 1 month after treatment
Oswestry disability index
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
Measured: At 3 month after treatment
Oswestry disability index
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
Measured: At 6 month after treatment
Secondary outcomes (4)
Visual analogic scale
pain rating scale from 0 to 10 (worst is 10)
Measured: Initially and at 1 month, 3 month and 6 month after the procedure
Off work duration
days before returning to work
Measured: Initially and at 1 month, 3 month and 6 month after the procedure
Hospitalization duration
overnights hospitalization stays following the intervention
Measured: Initially and at 1 month, 3 month and 6 month after the procedure
use of pain killers
frequency of the use of painkillers before and after the intervention
Measured: Initially and at 1 month, 3 month and 6 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Dec 2019
- Primary completion30 Apr 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772143
- Sponsor's protocol ID
- 23Imagerie01
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not scheduled
Publications
Ranc PA, Rudel A, Bentellis I, Prestat A, Elbaze S, Sala V, Torre F, Pavan LJ, Uri IF, Amoretti N. Patient-Reported Outcomes and Return to Work after CT-Guided Percutaneous Lumbar Discectomy: A Prospective Study. J Vasc Interv Radiol. 2024 Mar;35(3):390-397. doi: 10.1016/j.jvir.2023.12.007. Epub 2023 Dec 16.
PubMed 38110149
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Lumbar Discectomy : Evaluation of Patient Reported Outcomes, Aconomical Impact and Return to Work
- ClinicalTrials.gov ID
- NCT05772143
- Acronym / sponsor ID
- 23Imagerie01
- Conditions
- Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 16 Mar 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.
This study aims to evaluate the clinical (pain) and functional (patient reported outcomes) efficacy of percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.
The aim is also to evaluate the economic impact of the procedure, mainly through the length of hospitalization and the time to return to work.
Patients were evaluated initially before surgery and then at 1, 3 and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar disc herniation | – | Procedure: Percutaneous discectomies under CTPatient over 18 years of age suffering from radiculalgia related to lumbar disc herniation visualized on MRI with radio-clinical concordance, failure of conservative treatment and nerve root infiltrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years of age suffering from radiculalgia related to lumbar disc herniation visualized on MRI with radio-clinical concordance, failure of conservative treatment and nerve root infiltrations ; consulting in interventionnal radiology care unit,
Key inclusion criteria (3 listed)
- radiculalgia related to lumbar disc herniation with clinical radiological concordance
- age > 18
- resistance to conservative treatment and nerve root infiltrations
Key exclusion criteria (5 listed)
- prior discal surgery at the same level,
- lumbar canal stenosis,
- extruded discal herniation,
- neurological deficit,
- no capacity to answer to follow-up calls
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 |
|---|---|---|
| Percutaneous discectomies under CTPercutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations. | Procedure or surgery | Lumbar disc herniation |
Primary outcome
Oswestry disability index
Time frame: before treatment
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
Oswestry disability index
Time frame: At 1 month after treatment
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
Oswestry disability index
Time frame: At 3 month after treatment
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
Oswestry disability index
Time frame: At 6 month after treatment
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
4 secondary outcomes
Visual analogic scale
Time frame: Initially and at 1 month, 3 month and 6 month after the procedure
Off work duration
Time frame: Initially and at 1 month, 3 month and 6 month after the procedure
Hospitalization duration
Time frame: Initially and at 1 month, 3 month and 6 month after the procedure
use of pain killers
Time frame: Initially and at 1 month, 3 month and 6 month after the procedure
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 16 Mar 2023.
- Derived from this study: PubMed 38110149Ranc PA, Rudel A, Bentellis I, Prestat A, Elbaze S, Sala V, Torre F, Pavan LJ, Uri IF, Amoretti N. Patient-Reported Outcomes and Return to Work after CT-Guided Percutaneous Lumbar Discectomy: A Prospective Study. J Vasc Interv Radiol. 2024 Mar;35(3):390-397. doi: 10.1016/j.jvir.2023.12.007. Epub 2023 Dec 16.
- Individual participant dataSharing planned: No. Not scheduled
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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, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 3 inclusion and 5 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 16 Mar 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 France. 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?
Oswestry disability index (time frame: before treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05772143, which also lists 1 linked publication.
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 16 Mar 2023.