Effect of Drug Clinical Trial
Official title:
Comparative Effect of Transforaminal Injection of Magnesium Sulphate Versus Ozone Therapy on Oxidative Stress Biomarkers in Lumbar Disc Related Radicular Pain
Chronic lumbar radicular (CLR) pain is a term used to describe neuropathic pain symptoms in
the distribution of a particular lumbar nerve root due to disc protrusion, spinal stenosis,
facet hypertrophy, or fibrosis after previous surgery. The pathophysiology of CLR pain
involves mechanical, inflammatory, and immunologic factors that affect the function of the
dorsal root ganglion (DRG).1Treatment methods include oral pain medications, physical
therapy, epidural steroid injection (ESI) and surgery, among others. Both ESI and surgery
appear to result in short-term pain relief relative to more conservative measures, yet
neither is clearly superior to observation at 1-year follow-up (2,3).
Lumbar epidural steroid injection (LESI) was first suggested as a conservative treatment for
radicular pain in 1952 by Robecchi and Capra,4 and it has since become one of the most
commonly utilized conservative interventions for radiculopathy.5 Steroids are used to reduce
inflammation in the epidural space.6-10 LESI is performed via a transforaminal (TF), caudal
(C), or interlaminar (IL) approach in the lumbar spine; these approaches offer different
advantages and disadvantages, which may result in different outcomes.11-14 The TF approach is
perhaps the most favored because the injection site is adjacent to the nerve root, and only a
small volume of medication is required for injection.15 The C route is both the easiest and
the safest route and also seems to provide the most favorable analgesic effects. However,
this approach requires relatively large volumes of medication and is less specific to the
site of pathology.16 Previous studies have described the effectiveness of these methods in
the management of radiculopathy.17-22 Magnesium sulfate has not been familiar to
anesthesiologists until recently. It has drawn much attention in the field of
anesthesiology,23,24 resulting in numerous publications of clinical studies, 25 review
articles, and meta-analyses. 26 Based on its diverse roles in cellular functions, magnesium
sulfate has been suggested to prevent excitotoxicity by its neuroprotective effects.27
Magnesium can antagonize NMDA receptor channels by blocking calcium influx in a voltage-gated
manner. Intravenous administration of magnesium is efficacious in the management of various
conditions associated with neuropathic pain. 28,29 Collins and colleagues reported that 70
mg/kg magnesium sulphate infusions in 4 hours for 5 days reduced pain in patients with
complex regional pain syndrome. 30 Neuraxial administration of magnesium is an "off-label"
use However, animal studies 31,32 showed that intrathecally administered magnesium was free
of neurotoxicity, and recent studies have demonstrated the safety of magnesium administration
via the epidural route in humans33,34.35 Recently, ozone therapy has emerged as an
alternative or additional treatment option for patients with lumbar disc prolapse. Ozone (O 3
) is an allotropic form of oxygen, primarily known for its ecological properties, industrial
application and therapeutic effects. Questions persist concerning its potential toxicity as
an oxidant agent versus its reported clinical efficacy. Several mechanisms of action have
been proposed to explain the efficacy of ozone therapy including analgesic, anti-inflammatory
and oxidant action. The O2-O3 gas mixture injected proximal to the root ganglion is thought
to normalize the levels of cytokines and prostaglandins, increase superoxide dismutase levels
minimize reactive oxidant species and improve local periganglionic circulation with eutropic
effect on the nerve root36,37 Much concern was directed towardsthe contribution of oxidative
stress to the pathophysiology of disc prolapse. More and more researchers devote themselves
to elucidating the association between oxidative stress and disc degeneration. Antioxidative
therapy is suggested as a promising therapeutic approach for preventing or retarding the
establishment and progression of disc degeneration. The effect of interventional pain
procedures for lumbar disc prolapse on oxidative stress biomarkers such as Glutathione and
superoxide dismutase (SOD) remains unknown. 38
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