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|- ISRCTN||ISRCTN no longer applicable|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|
|- Main changes (audit trail)|
|- RECORD||26-sep-2017 - 5-okt-2017|
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