Transforaminal Epidural Injection in Acute Sciatica

Sciatica is a condition of radicular pain in the leg and is usually caused by
herniation of a lumbar intervertebral disc. The herniated disc compresses a
lumbar nerve root that continues its route into the sciatic nerve. About 13% to
40% of all people will suffer from sciatica at least once during their
lifetime. Sciatica can have severe socio-economic effects; patients are
immobilised by the pain they experience and therefore cannot go to work or
participate in social events.
Most cases resolve spontaneously with conservative therapy using only standard
analgesics and/or physiotherapy. In a large RCT it was demonstrated that
outcome of conservative and surgical therapy was comparable after 26 weeks.
With this knowledge the guidelines for surgical treatment of sciatica were
adjusted and it is nowadays usual care to offer surgery only after at least 8
weeks of conservative care and preferably after 14-16 weeks of conservative
care. This decision is made together with the patient in a process of Shared
Decision making.
Although this treatment regimen has been demonstrated to be efficacious and
cost effective, the burden for a patient during these weeks of conservative
care is usually high. We seek to find a type of conservative care to reduce the
discomfort due to the pain and to enable the patient to remain physically
active. Not only will this add to the quality of life of the patient, but it
will also prevent the patient from taking a sick-leave.

1. To study effectivity of the epidural injection with analgesic and
anti-inflammatory medication to relieve the symptoms within two weeks follow up.
It will be evaluated in what percentage of patients the decrease in leg pain is
satisfactory in both treatment arms at two weeks follow up. A satisfactory
effect is defined as a decrease in NRS (Numeric Rating Scale) leg pain to a
value below 4 points on a 10 points scale. It will be evaluated how long the
effect lasts. The legpain and functionality at 4 weeks after
injection/randomization will also be evaluated to get informed on the
responsiveness on TEI in a somewhat later stage.
2. To evaluate the outcome of TEI in the first two weeks after injection as a
predictor of NRS legpain at 14-16 and ca 26 weeks after onset of legpain. The
hypothesis is that being non-responsive to TEI within two weeks, predicts an
unsatisfactory condition after 14-16 weeks of suffering. This is the category
of patients that in contemporary care in the Netherlands will be offered a
surgical intervention. If our hypothesis is correct, in the future, this
population of patients can be offered a surgical intervention at an earlier
timepoint.
3. To evaluate the cost-effectivity of analgesic/anti-inflammatory epidural
injections to relieve symptoms of early sciatica
4. A portion of the patients in this study will eventually have an MRI of the
lumbar spine and/or will eventually be operated. MRI data and histological data
from disc material will be correlated to clinical data.

This is a randomized controlled trial on patients suffering from acute sciatica
(3-8 weeks pain in the leg with a NRS >= 6) (see inclusion and exclusion
criteria) in which consecutive patients who meet the inclusion criteria are
invited to participate in the trial. Clinical and demographic data are
gathered, as well as details on the injection (timing and frequency) and
prevailing complications.
NRS legpain that decreases below the value of 4 within two weeks after TEI is
documented as successful effect of TEI. NRS legpain that remains higher than a
value of 4 at a time interval of two weeks after TEI makes a patient eligible
for surgery if the patient requests for surgery. General guidelines for timing
of surgery will be conducted, meaning that the patient is encouraged to
postpone surgery till 14-16 weeks after onset of pain. This decision is made
using Shared Decision Making and it is possible that the patient is operated
before the 14-16 week timepoint. The patients who are randomized cannot be
operated in the first two weeks after randomization, unless sudden loss of
strength or a cauda equina syndrome is reported. Four weeks after
injection/randomization the outcome measures are measured again to be informed
on the late effect of TEI.
Randomization will take place using block randomization.

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 care
- For injections above L3: 1,5 ml lidocaine 1% and 10mg dexamethasone is
injected transforaminally in close proximity of the nerve root, according to
usual care
- If necessary, oral pain medication and/or physiotherapy

The other treatment arm will be treated with only oral pain medication and/or
physiotherapy.

Burden: participants will be asked to fill in questionnaires. This will be
performed electronically and the estimated burden is low.
Risk: risks, predominantly from treatment with TEI, are equal to risks occuring
from usual care for sciatica. TEI as an intervention tool is considered usual
care for sciatica patients.