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 herniatio
- Conditions
- SciaticaMusculoskeletal DiseasesDorsalgia
- Registration Number
- ISRCTN25884790
- Lead Sponsor
- eiden University Medical Centre (LUMC) (Netherlands)
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 115
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Roland Disability Questionnaire for Sciatica
- Secondary Outcome Measures
Name Time Method <br> 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.<br> 2. Neurological and radiological parameters<br>