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
March 6, 2023 updated by: Centre Hospitalier Universitaire de Nice
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
87
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nice, France
- CHU de Nice
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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,
Description
Inclusion Criteria:
- radiculalgia related to lumbar disc herniation with clinical radiological concordance
- age > 18
- resistance to conservative treatment and nerve root infiltrations
Exclusion Criteria:
- prior discal surgery at the same level,
- lumbar canal stenosis,
- extruded discal herniation,
- neurological deficit,
- no capacity to answer to follow-up calls
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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Percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry disability index
Time Frame: before treatment
|
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
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before treatment
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Oswestry disability index
Time Frame: At 1 month after treatment
|
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
|
At 1 month after treatment
|
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Oswestry disability index
Time Frame: At 3 month after treatment
|
Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
|
At 3 month after treatment
|
|
Oswestry disability index
Time Frame: At 6 month after treatment
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Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders
|
At 6 month after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogic scale
Time Frame: Initially and at 1 month, 3 month and 6 month after the procedure
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pain rating scale from 0 to 10 (worst is 10)
|
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
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days before returning to work
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Initially and at 1 month, 3 month and 6 month after the procedure
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|
Hospitalization duration
Time Frame: Initially and at 1 month, 3 month and 6 month after the procedure
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overnights hospitalization stays following the intervention
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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
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frequency of the use of painkillers before and after the intervention
|
Initially and at 1 month, 3 month and 6 month after the procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
October 31, 2021
Study Registration Dates
First Submitted
March 6, 2023
First Submitted That Met QC Criteria
March 6, 2023
First Posted (Actual)
March 16, 2023
Study Record Updates
Last Update Posted (Actual)
March 16, 2023
Last Update Submitted That Met QC Criteria
March 6, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23Imagerie01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not scheduled
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.