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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- ISRCTNISRCTN no longer applicable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 summary
- Main changes (audit trail)
- RECORD26-sep-2017 - 5-okt-2017


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