Herniated Disc Clinical Trial
Official title:
Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment
Verified date | March 2008 |
Source | Rijnstate Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | ArthroCare Corporation, Maastricht University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in Jensen visual analogue scale (VAS)-score for pain | |||
Secondary | McGill Pain Questionnaire-Dutch Language Version (MPQ-DLV) | |||
Secondary | Quebec Back Pain Disability Scale | |||
Secondary | Rand-36 | |||
Secondary | EuroQoL (European Quality of Life Scale) | |||
Secondary | Costs (societal perspective) | |||
Secondary | Multidimensional Pain Inventory (MPI-DLV) |
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