Herniated DiscPhase 3NCT00124774
Nucleoplasty for Contained Herniated Lumbar Discs
A Phase 3 study testing Nucleoplasty in people with Herniated Disc, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Herniated Disc
- What is being tested?
- Nucleoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2004to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment
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.
Read the 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.
- Conditions
- Herniated Disc
- Being tested
- Nucleoplasty
- Keywords
- hernia, nucleoplasty, radicular pain, Contained lumbar herniated disc
- Medical subject headings
- Intervertebral Disc Displacement, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NucleoplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Multidimensional Pain Inventory (MPI-DLV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startNov 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, ArthroCare Corporation
- Investigators
- Michel Terheggen, MD, Principal investigator, Rijnstate HospitalMaarten van Kleef, MD, PhD, Study chair, UMC Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124774
- Sponsor's protocol ID
- 04-269
- Status last verified
- Mar 2008
- First submitted
- 27 Jul 2005
- Last updated
- 1 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nucleoplasty for Contained Herniated Lumbar Discs: A Randomised, Double Blind, Prospective Comparison With Sham Treatment
- ClinicalTrials.gov ID
- NCT00124774
- Acronym / sponsor ID
- 04-269
- Conditions
- Herniated Disc
- Keywords
- hernia, nucleoplasty, radicular pain, Contained lumbar herniated disc
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Maastricht University, ArthroCare Corporation
- Study start
- Nov 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 28 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nucleoplasty | Procedure or surgery | – |
Primary outcome
Decrease in Jensen visual analogue scale (VAS)-score for pain
6 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Terheggen, MD principal investigator
Rijnstate Hospital
Maarten van Kleef, MD, PhD study chair
UMC Maastricht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nucleoplasty in people with Herniated Disc, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Jensen visual analogue scale (VAS)-score for pain. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.