herniated nucleus pulpos patients
Conditions
Interventions
Intervention condition: Mechanical Diagnosis and Treatment (McKenzie treatment) (with Transforaminal Epidural Steroid Injection(s)) while being at the waiting list to receive lumbar disc surgery.
Con
Sponsors
VU Amsterdam, Faculty FALW, Dept. of Health Sciences, room T557, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands
Eligibility
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, 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 criteria
Exclusion criteria: A 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgery rate, number of patients undergoing surgery during a 12-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Contacts
Public ContactR.W.J.G. Ostelo
Postbus 7057
Outcome results
None listed