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

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: Percutaneous discectomies under CT

• Registration Number: NCT05772143
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-10-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-06
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar disc herniation	Percutaneous discectomies under CT	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

Primary Outcome Measures

Name	Time	Method
Oswestry disability index	At 6 month after treatment	Fonctionnal indicator of incapicity validated for patient suffering from spinal disorders

Secondary Outcome Measures

Name	Time	Method
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)
Hospitalization duration	Initially and at 1 month, 3 month and 6 month after the procedure	overnights hospitalization stays following the intervention
Off work duration	Initially and at 1 month, 3 month and 6 month after the procedure	days before returning to work
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

Trial Locations

Locations (1)

Chu de Nice; 🇫🇷 Nice, France