Effect of adjuvant hypertonic saline in Transforaminal Epidural Steroid injection for the management of patients with chronic lumbosacral radiculopathy: A double blind, prospective, randomized trial.

Low backache is one of the leading causes of disability in the world’s middle and older populations. Low backpain impairs middle-aged people’s productivity and quality of life. Chronic lumbosacral radiculopathy is one of the important differential diagnoses of low backache. Chronic lumbosacral radiculopathy refers to a pain syndrome characterized by the compression or irritation of nerve roots in the lumbosacral region of the spine. Transforaminal Epidural steroid injection is used in patients when all conservative management has failed. Many adjuvants have been added to the steroid injection and hypertonic saline is one of such agent that has generated interest in recent literature.

Hypertonic saline (HS) has been recently proposed to be a useful adjuvant in TFESI for the management of chronic lumbosacral radicular pain. HS is believed to have a substantial anti-inflammatory action through its osmotic action which translocate the fluid from intracellular to extracellular space. In addition to this, HS has been shown to reduce the inflammatory cytokines and acute phase reactants while also inhibiting the leukocyte migration at the site of inflammation. Likewise, HS has cytotoxic effects on fibrous tissues, which are formed in and around degenerated, herniated disc. Since spinal nerve root inflammation and oedema lies at the core of chronic lumbosacral radiculopathy, HS could have an additional positive effect on pain management in this condition.

Multiple studies have reported HS to be effective for radicular pain in lumbosacral radiculopathy secondary to herniated disc, spinal stenosis, and post laminectomy syndrome. Manchikanti et al. showed significant clinical improvement with the epidural administration of HS for adhesiolysis. However, these studies contain significant limitations such as small sample size, the confounding effect of additional agents like hyaluronidase, and shorter follow-up periods. Therefore, we aimed to determine the effect of an adjuvant HS in transforaminal ESI in pain management of chronic lumbosacral radiculopathy.

We hypothesize that the clinical efficacy of 3% hypertonic saline in transforaminal epidural steroid is superior to conventional transforaminal epidural steroid  in patients with chronic lumbosacral radiculopathy. The aim of the study is to gather more evidence on the efficacy of adjuvant hypertonic saline in transforaminal epidural steroid injection.