lumbar radiculopathy Sciatica
Conditions
Interventions
One treatment arm will be treated with TEI:
- For injections below L3 :1,5ml lidocaine 2% and 40mg depomedrol is injected
transforaminally in close proximity of the nerve root, according to usual car
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Suffering from sciatica Leg pain of 6 or more on a 10 point NRS (Numeric Rating Scale) scale with a duration of >3 and
Exclusion criteria
Exclusion criteria: Age under 18 years Condition preventing to receive TEI Severe scoliosis TEI received in 6 months before randomization date Surgery for sciatica at the same level Surgery for sciatica at another level within one year before inclusion Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pain intensity in the leg and the back will be measured with a 10 point horizontal Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The percentage of patients that demonstrated a decrease in NRS legpain | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS back pain: The pain intensity in the leg and the back will be measured with a 10 point horizontal Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS scores will be measured at baseline and at 1, 2, 4, 10 and 21 weeks after randomization. Oswestry Disability Index (ODI): The functionality of the patient with a focus on walking and daily activities will be measured with the Oswestry Disability Index that is usually measured in sciatica complaints. The scale ranges from 0 (no disability) to 50 (worst disability possible). The ODI scores will be measured at baseline and at 1, 2, 4, 10 and 21 weeks after randomization. EuroQoL (EQ-5D): The EuroQoL (five point EQ-5D) will be used for the cost utility analysis. The EuroQol scores will be measured at baseline and at 2, 10 and 21 weeks after randomization. Likert perceived recovery patient: To measure the perceived recovery a seven-point Likert scale will be used. The score on this scale vary from *completely recovered* to *worse than ever*. The Likert scores will be measured at baseline and at 1, 2, 4, 10 and 21 weeks after randomization. Costs (Cost intervention, health care use, and loss of productivity): Cost diaries will be filled out at 10 and 21 weeks after randomisation. Complications: PostTEI exacerbation of VAS legpain (>1 point additional leg pain) that lasts for at least 24 hours will be documented as a clinically relevant complication of TEI. Radiological parameters: MRI data will be evaluated by two independent researchers, blinded for clinical and histological data Histology: disc material from the operation will be histologically evaluated and data will be quantified by two independent researchers, blinded for clinical and MRI data Demographic data: demographic data will be collected at baseline TEI data: data with respect to timing of injection, number of injections, legpain after injectie and complications will be documented. | — |
Countries
Netherlands
Outcome results
None listed