EUCTR2017-002119-33-NL
Active, not recruiting
Phase 1
The PLUS study: Preventing LUmbar Disc Surgery - PLUS study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- umbosacral Radicular Syndrome
- Sponsor
- ZonMW
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 (with or without back pain) that had lasted for a minimum of 6 weeks
- •with or without mild neurological deficit (MRC higher than 3\)
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •A potentially eligible subject who meets any of the following criteria will be excluded from participation in this study:
- •Patients exclude 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 months
- •Bony stenosis
- •Spondylolisthesis
- •Pregnancy
- •Complicated disc herniation requiring more operations
- •Severe coexisting disease e.g. osteoporosis, dementia
- •Patient with contra\-indications for steroids injections
Outcomes
Primary Outcomes
Not specified
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