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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Completed
CT.gov ID
NCT05772143
Collaborator
(none)
87
1
23
3.8

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous discectomies under CT

Study Design

Study Type:
Observational
Actual Enrollment :
87 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Percutaneous Lumbar Discectomy : Evaluation of Patient Reported Outcomes, Aconomical Impact and Return to Work
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm 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

Procedure: Percutaneous discectomies under CT
Percutaneous discectomies under CT guidance to treat lumbar disc herniations resistant to conservative treatment and nerve root infiltrations.

Outcome Measures

Primary Outcome Measures

  1. Oswestry disability index [before treatment]

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

  2. Oswestry disability index [At 1 month after treatment]

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

  3. Oswestry disability index [At 3 month after treatment]

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

  4. Oswestry disability index [At 6 month after treatment]

    Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

Secondary Outcome Measures

  1. Visual analogic scale [Initially and at 1 month, 3 month and 6 month after the procedure]

    pain rating scale from 0 to 10 (worst is 10)

  2. Off work duration [Initially and at 1 month, 3 month and 6 month after the procedure]

    days before returning to work

  3. Hospitalization duration [Initially and at 1 month, 3 month and 6 month after the procedure]

    overnights hospitalization stays following the intervention

  4. use of pain killers [Initially and at 1 month, 3 month and 6 month after the procedure]

    frequency of the use of painkillers before and after the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu de Nice Nice France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05772143
Other Study ID Numbers:
  • 23Imagerie01
First Posted:
Mar 16, 2023
Last Update Posted:
Mar 16, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2023