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
| ISRCTN | ISRCTN25884790 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25884790 |
| Secondary identifying numbers | P04.042; NTR219 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 10/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr B. Schenk
Scientific
Scientific
Leiden University Medical Center
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| b.schenk@lumc.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | Percutaneous laser disc decompression (PLDD) is more cost-effective than conventional surgical treatment for lumbar disc herniation and allows faster patient rehabilitation, while long-term functional results are comparable. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Sciatica |
| Intervention | Patients who fit the inclusion 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 disc decompression will be carried out by an experienced interventional (neuro-)radiologist |
| Intervention type | Other |
| Primary outcome measure | Roland Disability Questionnaire for Sciatica |
| Secondary outcome measures | 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. 2. Neurological and radiological parameters |
| Overall study start date | 01/11/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 330 |
| Total final enrolment | 115 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
University/education
University/education
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Government
The Dutch Health Care Insurance Board (CVZ) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/05/2009 | Yes | No | |
| Results article | results | 01/05/2015 | 10/07/2019 | Yes | No |
| Results article | results | 01/06/2017 | 10/07/2019 | Yes | No |
Editorial Notes
10/07/2019: Publication reference and total final enrolment added.
