Nucleoplasty for Contained Herniated Lumbar Discs

Herniated Disc Clinical Trial

Official title: Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment

Status Completed

Clinical Trial Summary

This is a prospective randomised double blind comparison trial. Fifty patients will be included, 25 in the nucleoplasty treatment group, 25 in the control group. The nucleoplasty group will undergo the nucleoplasty treatment. Control group will undergo a sham treatment. Both groups will undergo a standardised post-operative care program. The study hypothesis is that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.

Clinical Trial Description

This study will include patients with a contained lumbar hernia of at least 6 weeks existence in whom leg pain is the predominant complaint. Standard treatment for these patients is conservative, as an operation is not without risks and is not always effective. Furthermore, complaints will usually resolve in due time. However, the pain limits the patients in their daily activities, often for a prolonged period.

In this study, nucleoplasty will be compared with a sham treatment and not with conservative treatment, as the discography is thought to have some therapeutic effect.

The primary outcome will be the proportion of patients with at least a 2.5 points decrease on a ten-point Jensen VAS score 3 months after treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herniated Disc
• Intervertebral Disc Displacement

• NCT number: NCT00124774
• Study type: Interventional
• Source: Rijnstate Hospital
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Completion date: April 2006