Prospective randomised double blind comparison trial. 50 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.Study hypothesis is that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.

Condition	Intervention	Phase
Contained lumbar herniated disc	Procedure: Nucleoplasty  Procedure: sham treatment	Phase III

Further Study Details: 

Primary Outcomes: Decrease in Jensen VAS-score for pain
Secondary Outcomes: MPQ-DLV; Quebec Back Pain Disability Scale; Rand-36; EuroQoL; Costs (societal perspective); Multidimensional Pain Inventory MPI-DLV
Expected Total Enrollment:  50

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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

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. - 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 clinical 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 gr 3 MRC or more - 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-coagula therapy - Infection - Pregnancy

Please refer to this study by ClinicalTrials.gov identifier  NCT00124774

Michel Terheggen, MD      31-263788888  Ext. 3560    mterheggen@alysis.nl

Netherlands
      Rijnstate Hospital, ARNHEM,  6800 TA,  Netherlands; Recruiting

Study chairs or principal investigators

michel Terheggen, MD,  Principal Investigator,  Rijnstate Hospital   
Maarten van Kleef, MD, PhD,  Study Chair,  UMC Maastricht   

Study ID Numbers:  04-269
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124774
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
ClinicalTrials.gov processed this record on 2005-08-02