Skip to content

The Sciatica-PLDD trial.

The Sciatica-PLDD trial, a prospective randomised controlled efficiency and efficacy trial on Percutaneous Laser Disc Decompression as a treatment modality for sciatica caused by a lumbar disc herniation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25415
Enrollment
330
Registered
2005-09-05
Start date
2004-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sciatica caused by lumbar disc herniation

Interventions

Patients who fit the in- 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 hos

Sponsors

The Dutch Health Care Insurance Board Postbus 320 Diemen 1110 AH Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient age 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 CT- or MRI imaging with a anteroposterior diameter less than 33% of the spinal canal; 5. Informed consent.

Exclusion criteria

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 < 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.

Design outcomes

Primary

MeasureTime frame
Roland Disability Questionnaire for Sciatica.

Secondary

MeasureTime frame
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. Neurological and radiological parameters will also be assessed.

Contacts

Public ContactB. Schenk

Leiden University Medical Center (LUMC), P.O. Box 9600

b.schenk@lumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)