Working... Menu

Nucleoplasty for Contained Herniated Lumbar Discs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124774
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : April 1, 2008
Maastricht University
ArthroCare Corporation
Information provided by:
Rijnstate Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Herniated Disc Procedure: Nucleoplasty Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment
Study Start Date : November 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herniated Disk

Primary Outcome Measures :
  1. Decrease in Jensen visual analogue scale (VAS)-score for pain

Secondary Outcome Measures :
  1. McGill Pain Questionnaire-Dutch Language Version (MPQ-DLV)
  2. Quebec Back Pain Disability Scale
  3. Rand-36
  4. EuroQoL (European Quality of Life Scale)
  5. Costs (societal perspective)
  6. Multidimensional Pain Inventory (MPI-DLV)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mono radicular leg pain for at least 6 weeks as a result from a lumbar contained herniated disc. Leg pain must be of greater impact than concomitant back-pain
  • Failing conservative treatment; analgesics and/or physical therapy. Failing means persisting pain leading to problems with daily activities.
  • Magnetic resonance imaging (MRI): must be performed < 6 weeks before start treatment. On MRI signs of contained herniated disc, maximum 33% obliteration of the spinal channel. No signs of other significant spine pathology (see exclusion criteria).
  • Neurological investigation by neurologist. Symptoms should be clinically related to the disc herniation level.
  • Age >18 and < 60 years
  • Mean leg pain on visual analogue scale (VAS) >50 mm (0 -100)

Exclusion Criteria:

  • Herniated disc with more than 33% obliteration of the spinal channel.
  • Annulus rupture with sequestrated herniated disc.
  • Pain on VAS below 50 mm
  • Pain existing longer than one year
  • Less than 50% preserved disc height
  • Conflict with social security/insurance.
  • Major motor impairment as a result of the herniation, paresis grade 3 or more using a Medical Research Council (MRC) score
  • Other degenerative causes of nerve root compression; ligament flavum or facet joint hypertrophy, degenerative spinal channel stenosis, loss of lumbar kyphosis, discopathy with signs of Schmorls' nodules and loss of nucleus pulposus signal. Other causes of radicular syndrome such as cancer, radiculitis or neural degeneration.
  • Spinal instability (spondylolisthesis, spinal fracture or tumor)
  • History of back surgery, chemonucleolysis or other intra discal procedures
  • Coagulopathies or oral anti-coagulation therapy
  • Infection
  • Pregnancy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00124774

Layout table for location information
Rijnstate Hospital
Arnhem, Netherlands, 6800 TA
Sponsors and Collaborators
Rijnstate Hospital
Maastricht University
ArthroCare Corporation
Layout table for investigator information
Principal Investigator: Michel Terheggen, MD Rijnstate Hospital
Study Chair: Maarten van Kleef, MD, PhD UMC Maastricht

Layout table for additonal information Identifier: NCT00124774     History of Changes
Other Study ID Numbers: 04-269
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008

Keywords provided by Rijnstate Hospital:
radicular pain
Contained lumbar herniated disc

Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical