The PLUS Study: Preventing Lumbar disc surgery

• Conditions: sciatica and herniated nucleus pulposus; 10028377

• Registration Number: NL-OMON50214
• Lead Sponsor: ZonMw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 146

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
than 3
• 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
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
• Insufficient knowledge of the Dutch language
• Emergency surgery as determined by the neurosurgeon
• Being allergic for OMNIPAQUE 240

Study & Design

• Study Type: Interventional
• Study Design: Not specified