Contact information
Type
Scientific
Primary contact
Mr B. Schenk
ORCID ID
Contact details
Leiden University Medical Center
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
b.schenk@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P04.042; NTR219
Study information
Scientific title
Acronym
Study hypothesis
Percutaneous laser disc decompression (PLDD) is more cost-effective than conventional surgical treatment for lumbar disc herniation and allows faster patient rehabilitation, while long-term functional results are comparable.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Sciatica
Intervention
Patients who fit the inclusion and exclusion criteria for the trial for lumbar disc herniation will be randomised into two groups:
1. The first group will receive microsurgical discectomy in their own hospital
2. The second group will be referred to 1 of 4 assigned PLDD-centers, where percutaneous laser disc decompression will be carried out by an experienced interventional (neuro-)radiologist
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Roland Disability Questionnaire for Sciatica
Secondary outcome measures
1. A cost-effectiveness-analysis will be carried out on the basis of health-related utility factors. This will include costs of sickness absence and long-term disability.
2. Neurological and radiological parameters
Overall trial start date
01/11/2004
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient aged 18 - 70 years
2. At least 8 weeks of persisting sciatic pain with or without paresis or sensory impairment
3. Patients must qualify for surgical intervention
4. Clear unilateral lumbar disc herniation on computed tomography (CT) or magnetic resonance imaging (MRI) with a anteroposterior diameter less than 33% of the spinal canal
5. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant exclusion criteria
1. Previous discectomy at the same level
2. Cauda equina syndrome
3. Lytic or degenerative spondylolisthesis
4. Spinal/lateral recess stenosis
5. Intervertebral disc space of less than 7 mm
6. Signs of sequestration
7. Pregnancy
8. Serious co-morbidity, either somatic or psychiatric
9. Emigration in the near future
10. No or insufficient knowledge of the Dutch language
Recruitment start date
01/11/2004
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The Dutch Health Care Insurance Board (CVZ) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19439098
Publication citations
-
Protocol
Brouwer PA, Peul WC, Brand R, Arts MP, Koes BW, van den Berg AA, van Buchem MA, Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial., BMC Musculoskelet Disord, 2009, 10, 49, doi: 10.1186/1471-2474-10-49.