Transforaminal Epidural Steroid Injections for Acute Lumbosacral Radicular Syndrome without prior consultation with a neurologist or diagnostic imaging.

With an incidence of 9 per 1000 patients per year in the Netherlands, acute
lumbosacral radicular syn-drome (aLRS) is a common problem. The most common
cause is a herniated disc. The natural course is generally favourable; the
radiculopathy usually diminishes within three months and con-servative
treatment suffices. In the first six to eight weeks, conservative treatment is
therefore first choice. If oral medication gives insufficient pain relief,
generally a transforaminal epidural steroid injection (TFESI) is performed.
This treatment is seen as part of conservative therapy. Also, when pain has
been present for more than three months, a TFESI is often carried out before
considering surgical treatment as it is less invasive. TFESI is part of
standard care and is covered by the standard health insurance package.

TFESI consists of administration of a long acting steroid in the epidural space
around the nerve root in the neuroforamen. In aLRS due to a herniated disc, an
inflammatory process is involved. The injected steroid reduces inflammation
thereby limiting oedema and thus reduces pressure to the nerve root. In
addition, persistent noxious stimulation from inflammatory mechanisms might
explain central sensitization in patients with aLRS. The anti-inflammatory
effect of steroids might prevent central sensitization. There is a negative
correlation between the duration of aLRS and the responsiveness to epidural
steroid injections.

Upon presentation at the general practitioner (GP), patients with aLRS are
treated conservatively with oral pain medication for a period of six to eight
weeks. In this period, patients are only referred to a neurologist when the
following conditions apply: suspected cauda equina syndrome, severe paresis, a
(history of) malignancy or if the pain could be explained by another rare
and/or serious condition. In addition, a patient is referred to a neurologist
if oral pain medication gives insufficient pain relief, at times, already
within the first six to eight week period. Generally, the neurologist,
guideline conform not the GP directly, refers these patients to a pain
specialist for TFESI. Generally these patients are offered a TFESI as part of
conservative treatment. Generally, the neurologist, guideline conform not the
GP, refers these patients to a pain specialist for TFESI. Within Noordwest
Ziekenhuisgroep it is estimated that neurologists refer the majority of these
patients with pain despite medication to the pain specialist for a TFESI.

Prior to referring a patient to a pain specialist, diagnostic Magnetic
Resonance Imaging (MRI) is often requested by the neurologist. However, in
accordance with the current guideline, imaging for aLRS is only indicated when
surgical intervention is considered or symptoms may be explained by another
serious condition.1 There is consensus with the Dutch Association for Neurology
(NVN), the Dutch Association for Neurosurgery (NVVN) and the Dutch Orthopaedic
Association (NOV) that diagnostic imaging is performed only in case of
suspicion of a serious condition causing the radicular pain or if surgical
treatment is considered, as also expressed in 'Wise choices for a low back
hernia' by the Order of Medical Specialists, ZonMw and Dutch Patient Federation
(NPCF).15

Preceding a TFESI, patients always have an intake at the pain clinic to confirm
the diagnosis aLRS and to determine the nerve root to be treated. Diagnostic
imaging is not required for TFESI. Consulta-tion with a neurologist and
diagnostic imaging might be superfluous prior to a TFESI for aLRS; this
suggests cost-effective changes in logistics could be made. In addition, this
change in logistics could improve responsiveness to TFESI given the negative
correlation between the duration of aLRS and the responsiveness to TFESI.
During this feasibility study only patients with aLRS and unbearable pain
despite oral pain medication who otherwise would also most likely receive a
TFESI will be includ-ed, but without prior consultation with a neurologist and
diagnostic imaging.

The aim of this study is to evaluate the pain improvement of patients with aLRS
treated with TFESI, after straight referral from the GP to the pain specialist
without diagnostic imaging and prior consulta-tion with a neurologist. Pain
improvement will be assessed three weeks after treatment using a 5-point Likert
scale.

This single centre feasibility study will be conducted in the Noordwest
Ziekenhuisgroep location Alkmaar in collaboration with GPs and will assess the
efficacy of a change in logistics of a clinical pathway for patients treated
for aLRS. This feasibility study will be used for sample size calculation for a
Randomized Clinical Trial. A follow-up study can evaluate safety and
cost-effectiveness, comparing usual care to the change in logistics implemented
for this study. This study will take a year to complete.

Treating patients suffering from unbearable pain despite oral medication with
TFESI is part of usual care and is covered by the standard health insurance
package.

Treating acute LRS with a TFESI, by straight referral from the GP to the pain
physician without prior consultation with a neurologist or diagnostic imaging.
The pain physician does an intake to confirm the diagnosis LRS and to determine
which nerve root to treat.

The change in logistics implemented for this study may potentially lead to a
small group of patients receiving a TFESI which they would not have received
outside study setting resulting in overtreatment. However, pain reduction due
to natural course within referral interval is always a possibility.
Furthermore, only patients with unbearable pain despite medication are included
in this study. In principle, these patients are all eligible for a TFESI. Due
to the adapted logistics in the study protocol, the patient sees the
anesthetist-pain specialist earlier. The logistics implemented during this
study could lead to patients a shorter period of pain complaints for the
patient. There is also an unethical aspect of prolonged unbearable pain. During
this study there is even a chance that patients who would otherwise be
immediately referred to a neurosurgeon will be adequately treated earlier.

TFESI is part of conservative treatment and usual care. Omitting diagnostic
imaging might lead to aforementioned red flags possibly being missed, however
momentarily neurologists also do not al-ways perform diagnostic imaging either.
If anamnesis shows there is a chance of underlying suffering (exclusion
criteria), patients are referred to a neurologist, conform the guideline.

Patients will get an intake appointment and an appointment for TFESI (invasive
treatment). Patients are asked to fill in a questionnaire, before (baseline)
and three weeks after treatment. Patients will be expected to be treated much
earlier than with usual care which might lead to a shorter duration of
inadequate pain relief.

If successful, patients treated with a TFESI will benefit from pain relief.
This may lead to reduction of pain medication, among others opiates.
Furthermore, if patients benefit from pain relief they will more likely be able
to return to work, reducing sick leave. The change in logistics implemented for
this study could improve responsiveness to a TFESI as there is a negative
correlation between the dura-tion of aLRS and the responsiveness to a TFESI.