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Clinical Trials/ISRCTN25884790
ISRCTN25884790Completed未知

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

eiden University Medical Centre (LUMC) (Netherlands)0 sites115 target enrollmentStarted: December 20, 2005Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
115

Study Overview

Brief Summary

  1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19439098 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25614151 (added 10/07/2019) 3. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28454511 (added 10/07/2019)

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

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

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

Investigators

Sponsor
eiden University Medical Centre (LUMC) (Netherlands)

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