NCT00124774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

First QC Date

July 27, 2005

Last Update Submit

March 28, 2008

Conditions

Herniated Disc

Keywords

hernianucleoplastyradicular painContained lumbar herniated disc

Outcome Measures

Primary Outcomes (1)

  • Decrease in Jensen visual analogue scale (VAS)-score for pain

Secondary Outcomes (6)

  • McGill Pain Questionnaire-Dutch Language Version (MPQ-DLV)

  • Quebec Back Pain Disability Scale

  • Rand-36

  • EuroQoL (European Quality of Life Scale)

  • Costs (societal perspective)

  • +1 more secondary outcomes

Interventions

NucleoplastyPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, 6800 TA, Netherlands

Location

MeSH Terms

Conditions

Intervertebral Disc DisplacementHernia

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michel Terheggen, MD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

  • Maarten van Kleef, MD, PhD

    UMC Maastricht

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2005

First Posted

July 28, 2005

Study Start

November 1, 2004

Study Completion

April 1, 2006

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

NL(1)