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Preventing lumbar disc surgery


- candidate number27952
- NTR NumberNTR6715
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-sep-2017
- Secondary IDsZONmw - 80-84300-98-71005 CCMO - NL60558.029.17
- Public TitlePreventing lumbar disc surgery
- Scientific TitleCost-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)
- ACRONYMThe PLUS study
- hypothesisA 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) studiedLumbar disc herniation
- Inclusion criteriaIn 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 criteriaA 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
Spondylolisthesis
Pregnancy
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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate30-jun-2020
- Target number of participants146
- InterventionsIntervention 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 outcomeSurgery 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.
- TimepointsTimepoint: baseline, 4 weeks, 2 months, 4 months, 6 months, 9 months, 12 months.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R.W.J.G. Ostelo
- CONTACT for SCIENTIFIC QUERIESDr. R.W.J.G. Ostelo
- Sponsor/Initiator VU University Medical Center, Department of Health Sciences
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryLumbosacral 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)
- RECORD26-sep-2017 - 28-okt-2017


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