Preventing lumbar disc surgery|
|- candidate number||27952|
|- NTR Number||NTR6715|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-sep-2017|
|- Secondary IDs||ZONmw - 80-84300-98-71005 CCMO - NL60558.029.17|
|- Public Title||Preventing lumbar disc surgery|
|- Scientific Title||Cost-effectiveness of combination therapy (Mechanical diagnosis & treatment [MDT] & Transforaminal Epidural Steroid Injections [TESIs]) vs Usual care (i.e. waiting list for lumbar herniated disc surgery)|
|- ACRONYM||The PLUS study|
|- hypothesis||A combination therapy (MDT and TESIs) is effective and cost-effective compared to usual care among herniated nucleus pulpos patients with an indication for a lumbar herniated disc surgery|
|- Healt Condition(s) or Problem(s) studied||Lumbar disc herniation|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria: |
• Incapacitating lumbosacral radicular syndrome with leg pain, NRS>6, (with or without back pain) that had lasted for a minimum of 6 weeks with or without mild neurological deficit (i.e. Medical Research Council [MRC]>3).
• MRI which confirms a HNP that compromises the spinal nerve and can explain the clinical symptoms of the patient
• The patients should according to usual care have an indication for HNP operation by a neurosurgeon.
• Signed informed consent for participation in the study
• 18 years and above
|- Exclusion criteria||A potentially eligible subject who meets any of the following criteria will be excluded from participation in this study: |
• Patients suffering from cauda equina syndrome
• Previous spine surgery at the same level during the previous 6 months
• Previous transforaminal injections at the same level during the 6 months
• Bony stenosis
• Complicated disc herniation requiring more than one operation
• Severe coexisting disease (e.g. osteoporosis, dementia)
• Patient with contra-indications for steroids injections
• Insufficient knowledge of the Dutch language
• Emergency surgery as determined by the neurosurgeon
• Being allergic for Iohexol 240mg/ml (i.e. OMNIPAQUE 240)
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2017|
|- planned closingdate||30-jun-2020|
|- Target number of participants||146|
|- Interventions||Intervention condition: Mechanical Diagnosis and Treatment (McKenzie treatment) (with Transforaminal Epidural Steroid Injection(s)) while being at the waiting list to receive lumbar disc surgery.|
Control condition: Being at the waiting list to receive lumbar disc surgery.
|- Primary outcome||Surgery rate, number of patients undergoing surgery during a 12-month follow-up.|
|- Secondary outcome||- Self-reported leg pain (0-100 numeric pain rating scale (NPRS)), Timepoint: baseline, 4 weeks, 2 months, 4 months, 6 months, 9 months, 12 months.|
- Self-reported back pain (0-100 NPRS), Timepoint: baseline, 4 weeks, 2 months, 4 months, 6 months, 9 months, 12 months.
- Functional status (Roland Morris Disability Questionnaires (RMDQ-23)), Timepoint: baseline, 2 months, 4 months, 6 months, 9 months, 12 months.
- Self-perceived recovery (Global Perceived Effect scale), Timepoint: 2 months, 4 months, 6 months, 9 months, 12 months.
- Health-related quality of life (SF-12; EQ-5D-5L), Timepoint: baseline, 2 months, 4 months, 6 months, 9 months, 12 months.
- Societal and healthcare costs, Timepoint: baseline, 2 months, 4 months, 6 months, 9 months, 12 months.
|- Timepoints||Timepoint: baseline, 4 weeks, 2 months, 4 months, 6 months, 9 months, 12 months.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. R.W.J.G. Ostelo|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.W.J.G. Ostelo|
|- Sponsor/Initiator ||VU University Medical Center, Department of Health Sciences|
(Source(s) of Monetary or Material Support)
|- Brief summary||Lumbosacral radicular syndrome is commonly caused by a herniated nucleus pulposus. In
the past decade, in the Netherlands, the incidence rate of sciatica has increased from 75 000
to 85000 per year, resulting in around 1.2 billion euros in direct and indirect costs per
year. The majority of sciatica patients end up receiving surgery even though conservative
treatment was previously found to be equally successful at long term follow-up. Moreover,
surgery is associated with high costs and complications. Conservative methods
for sciatica include transforaminal epidural steroid injections and physiotherapy/mechanical
diagnosis therapy, both of which have been reported to be individually successful treatments.
However, as far as we are concerned, our pilot study was the only study that has assessed the
effects of a combination therapy, consisting of mechanical diagnosis therapy and
transforaminal epidural injections, in reducing surgery rates. Hence, this study aims to
determine if such a combination therapy, while being on the waiting list for a lumbar herniated
disc surgery, is effective and cost-effective compared to usual care (i.e. no intervention
while being on the waiting list) in reducing surgery rates among HNP patients with an indication
for a lumbar herniated disc surgery.|
|- Main changes (audit trail)|
|- RECORD||26-sep-2017 - 28-okt-2017|
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