|- candidate number||1386|
|- NTR Number||NTR219|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||5-sep-2005|
|- Secondary IDs||P04.042 |
|- Public Title||The Sciatica-PLDD trial.|
|- Scientific Title||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.|
|- hypothesis||Percutaneous Laser Disc Decompression is more cost-effective than conventional surgical treatment for lumbar disc herniation and allows faster patient rehabilitation, while long-term functional results are comparable.|
|- Healt Condition(s) or Problem(s) studied||Sciatica, Lumbar disk|
|- 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||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;
8. Serious co-morbidity, either somatic or psychiatric;
9. Emigration in the near future;
10. No- or insufficient knowledge of the Dutch language.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2004|
|- planned closingdate||31-dec-2006|
|- Target number of participants||330|
|- 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 hospital.
2. The second group will be referred to 1 of 4 assigned PLDD-centers, where Percutaneous Laser Discus Decompression will be carried out by an experienced interventional (neuro)radiologist.
|- Primary outcome||Roland Disability Questionnaire for Sciatica.|
|- Secondary outcome||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.
|- Trial web site||http://www.pldd.nl|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| B. Schenk|
|- CONTACT for SCIENTIFIC QUERIES|| Patrick A. Brouwer|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Dutch Health Care Insurance Board (CVZ, independent governement organisation)|
|- Brief summary||The Sciatica-PLDD trial is a prospective randomized controlled trial. Patients who fit the in- and exclusion criteria for the trial for lumbar disc herniation will be randomised into twogroups. |
- The first group will receive microsurgical discectomy in their own hospital.
- The second group will be referred to 1 of 4 assigned PLDD-centers, where Percutaneous Laser Discus Decompression will be carried out by an experienced interventional (neuro)radiologist.
Patients in both groups will be treated within 4 weeks after randomisation. Follow up visits for both groups will take place in the referring hospital 4, 8, 26 and 52 weeks after treatment.
- Patient evaluation will consist of careful history taking and standardized physical examination by well trained, experienced research nurses. Additionally, patients will be asked to fill out questionnaires 2, 6, 12, 38, 78 en 104 weeks after treatment.
- The primary outcome measure is functional improvement. This will be assessed using the Roland Questionnaire for Sciatica. Moreover, 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.
|- Main changes (audit trail)|
|- RECORD||5-sep-2005 - 14-sep-2009|