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Nucleoplasty for Contained Herniated Lumbar Discs

This study has been completed.
Sponsor:
Collaborators:
Maastricht University
ArthroCare Corporation
Information provided by:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT00124774
First received: July 27, 2005
Last updated: March 28, 2008
Last verified: March 2008
History of Changes
  Purpose

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 Intervention Phase
Herniated Disc
 Procedure: Nucleoplasty
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Rijnstate Hospital:

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

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

Estimated Enrollment: 50
Study Start Date: November 2004
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124774

Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6800 TA
Sponsors and Collaborators
Rijnstate Hospital
Maastricht University
ArthroCare Corporation
Investigators
Principal Investigator: Michel Terheggen, MD Rijnstate Hospital
Study Chair: Maarten van Kleef, MD, PhD UMC Maastricht
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00124774     History of Changes
Other Study ID Numbers: 04-269
Study First Received: July 27, 2005
Last Updated: March 28, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Intervertebral Disk Displacement
Spinal Diseases
Bone Diseases
 Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013