Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pldd.nl

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 measures

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

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

http://www.lumc.nl/

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

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19439098

Publication citations

  1. 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.

Additional files

Editorial Notes