Herniated Disc
Conditions
Keywords
hernia, nucleoplasty, radicular pain, Contained lumbar herniated disc
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.
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.
Interventions
PROCEDURENucleoplasty
Sponsors
Maastricht University
ArthroCare Corporation
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in Jensen visual analogue scale (VAS)-score for pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Quebec Back Pain Disability Scale | — |
| Rand-36 | — |
| McGill Pain Questionnaire-Dutch Language Version (MPQ-DLV) | — |
| Costs (societal perspective) | — |
| Multidimensional Pain Inventory (MPI-DLV) | — |
| EuroQoL (European Quality of Life Scale) | — |
Countries
Netherlands
Outcome results
None listed