Lumbosacral Radicular Syndrome MedDRA version: 20.0 Level: LLT Classification code 10037739 Term: R sciatica System Organ Class: 100000014640
Conditions
Interventions
Trade Name: Omnipaque
Product Name: Omnipaque
Product Code: RVG09819
Pharmaceutical Form: Injection
Trade Name: Xylocaine (lidocaïnehydrochloride)
Product Name: Xylocaine
Product Code: RVG51674
Pharm
Sponsors
ZonMW
Eligibility
Sex/Gender
All
Inclusion 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 F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
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 • Insufficient knowledge of the Dutch language • Emergency surgery as determined by the neurosurgeon • Severe paresis MRC less than or equal to 3 • Being allergic for OMNIPAQUE 240
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the effectiveness and cost-effectiveness in terms of the number of surgeries prevented of a combination therapy versus usual care.;Secondary Objective: The secondary objective of this study is to assess the effectiveness and cost-effectiveness in terms of pain (leg and back), functioning, self-perceived recovery and health-related quality of life of a combination therapy versus usual care.;Primary end point(s): Surgery rate (number of patients undergoing surgery during a 12-month follow-up) ;Timepoint(s) of evaluation of this end point: Baseline and 2, 4, 6, 9 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), health-related quality of life (EQ-5D-5L) en societal costs.;Timepoint(s) of evaluation of this end point: Baseline, 4 weeks (only for pain), and 2, 4, 6, 9 and 12 months | — |
Countries
Netherlands
Contacts
Public ContactMOVE Research Institute Amsterdam
VU University Amsterdam
Outcome results
None listed