NL-OMON50214Not yet recruitingNot Applicable
The PLUS Study: Preventing Lumbar disc surgery - PLUS study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- ZonMw
- Enrollment
- 146
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion 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, medical research council (MRC) muscle scale higher
- •Magnetic resonance imaging (MRI) which confirms a lumbar 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 lumbar HNP
- •operation by a neurosurgeon.
- •Signed informed consent for participation in the study
- •18 years and above
Exclusion Criteria
- •Patients suffering from cauda equina syndrome
- •Previous spine surgery at the same level during the previous 6 months
- •Previous transforminal injections at the same level during the previous 6
- •Bony stenosis
- •Spondylolisthesis
- •Pregnancy
- •Complicated disc herniation requiring more operations
- •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 OMNIPAQUE 240
Investigators
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