Nucleoplasty for Contained Herniated Lumbar Discs
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|ClinicalTrials.gov Identifier: NCT00124774|
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : April 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Herniated Disc||Procedure: Nucleoplasty||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment|
|Study Start Date :||November 2004|
|Study Completion Date :||April 2006|
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00124774
|Arnhem, Netherlands, 6800 TA|
|Principal Investigator:||Michel Terheggen, MD||Rijnstate Hospital|
|Study Chair:||Maarten van Kleef, MD, PhD||UMC Maastricht|