Nucleoplasty for Contained Herniated Lumbar Discs
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment|
- Decrease in Jensen visual analogue scale (VAS)-score for pain
- McGill Pain Questionnaire-Dutch Language Version (MPQ-DLV)
- Quebec Back Pain Disability Scale
- EuroQoL (European Quality of Life Scale)
- Costs (societal perspective)
- Multidimensional Pain Inventory (MPI-DLV)
|Study Start Date:||November 2004|
|Study Completion Date:||April 2006|
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.
|Arnhem, Netherlands, 6800 TA|
|Principal Investigator:||Michel Terheggen, MD||Rijnstate Hospital|
|Study Chair:||Maarten van Kleef, MD, PhD||UMC Maastricht|