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.
ID
Bron
Verkorte titel
Aandoening
Sciatica caused by lumbar disc herniation
Ondersteuning
Postbus 320
Diemen
1110 AH
Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Roland Disability Questionnaire for Sciatica.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
P.O. Box 9600
B. Schenk
Albinusdreef 2
Leiden 2300 RC
The Netherlands
b.schenk@lumc.nl
Wetenschappers
P.O. Box 9600
B. Schenk
Albinusdreef 2
Leiden 2300 RC
The Netherlands
b.schenk@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL182 |
NTR-old | NTR219 |
Ander register | : P04.042 |
ISRCTN | ISRCTN25884790 |