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Nucleoplasty for Contained Herniated Lumbar Discs

Primary Purpose

Herniated Disc

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Nucleoplasty
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herniated Disc focused on measuring hernia, nucleoplasty, radicular pain, Contained lumbar herniated disc

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rijnstate Hospital

Outcomes

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)

Full Information

First Posted
July 27, 2005
Last Updated
March 28, 2008
Sponsor
Rijnstate Hospital
Collaborators
Maastricht University, ArthroCare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00124774
Brief Title
Nucleoplasty for Contained Herniated Lumbar Discs
Official Title
Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rijnstate Hospital
Collaborators
Maastricht University, ArthroCare Corporation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herniated Disc
Keywords
hernia, nucleoplasty, radicular pain, Contained lumbar herniated disc

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Nucleoplasty
Primary Outcome Measure Information:
Title
Decrease in Jensen visual analogue scale (VAS)-score for pain
Secondary Outcome Measure Information:
Title
McGill Pain Questionnaire-Dutch Language Version (MPQ-DLV)
Title
Quebec Back Pain Disability Scale
Title
Rand-36
Title
EuroQoL (European Quality of Life Scale)
Title
Costs (societal perspective)
Title
Multidimensional Pain Inventory (MPI-DLV)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Terheggen, MD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maarten van Kleef, MD, PhD
Organizational Affiliation
UMC Maastricht
Official's Role
Study Chair
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
ZIP/Postal Code
6800 TA
Country
Netherlands

12. IPD Sharing Statement

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Nucleoplasty for Contained Herniated Lumbar Discs

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