A Prospective Study of Efficacy of Epidural Steroid Therapy in Lumbar Radicular Pain

Vinoth KR, Srinivasan N and Raja Sekar MR^*

^*Correspondence: Raja Sekar MR, Department of Orthopaedics, Sree Balaji Medical College & Hospital Affiliated to Bharath Institute of Higher Education and Research, Chennai, Tamil Nadu, India, Email:

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Introduction

Low back ache is a quite common health problem, affecting up to eighty (80%) of the population at some point in life [1]. It was found to have the sixth top burden of the 291 conditions studied and caused more disability than any other condition. It is well known that back ache accounts for a large proportion of health care expenditures and that these expenditures have been increasing substantially, in fact these expenditures are increasing faster than overall health expenditures [2]. Low Back ache and sciatica are continuing leading cause of disability. Its lifetime incidence is 80%. The prevalence is high in our country because of difficult working situations and living environment.

This is a disabling condition for young adults and is the quietest common cause of limitation of physical activity, leading to loss of “working man days” [3]. The cause of low back ache remains a complex and likely multifactorial spectrum of degenerative diseases of the lumbar spine. Pain produced from problems with the intervertebral discs, misalignment of vertebra, zygapophysial joint arthritis, muscles, fascia, ligaments, or neural structures is difficult to determine. DePalma et al; found that the occurrence of zygapophysial joints was 31%, sacroiliac joints was 18%, and lumbar discs was 42%. He confirmed the lumbar disc as the most common cause of chronic low back pain in adults [4]. Sciatica is the most caused by Intervertebral disc prolapse but some patients with features suggesting sciatica does not show any disc prolapse in MRI or CT scan making it a paradox, this led to thinking of alternate cause of sciatica [5]. As the technology advanced, the understanding about sciatica has greatly improved leading to the understanding that pathogenesis of sciatica is indeed mediated by a combination of Inflammation, immunity, and factors of mechanical compression [6].

Steroids are supposed to reduce the inflammation by chemical, immunologic and mechanical lesions. Although the definite mechanism of action is not completely known, there is proof that corticosteroid provides pain relief by blockage of pro-inflammatory mediators and causing a reversible local anaesthetic effect [7]. Steroids can be used in patients with sciatica when they do not respond to nonsteroidal anti- inflammatory drugs. Local delivery of the steroids with or without a local anaesthetic agent into the epidural space which will cause an effect that lasts longer. So, in patients who do not respond to the conservative treatment within 3 months (NICE guidelines 2009) and not fit for surgical treatment, epidural steroid injections (ESI) can be administered. Epidural steroid injections have been used for sciatica since they were introduced around 60 years ago. Multiple studies have been performed on this subject and still the results were unequivocal [8].

Materials and Methods

Study location: The Department of Orthopaedics in Sree Balaji Medical College and Hospital, Chromepet, Chennai.

Study type: Prospective study.

Study duration: July 2017 to December 2019. This study shall be spread over a period of 30 months, but recruitment of new patients shall stop by DECEMBER 2018 so that the minimum follows up period shall be 12 months. Thus, the study recruitment period is of 18 months and study period was spread over a period of 30 months.

Study subject: 50 patients with lumbar radicular pain.

Study tools: Patients inclusion and exclusion criteria are given below:

Inclusion criteria

• Age more than18 years and less than 60 years.
• Back pain of duration greater than three months and radiculopathy with radiological evidence (MRI and X- ray of lumbar disc disease).
• MRI scan shows a herniated nucleosus pulposus (HNP) of intervertebral disc with below 50% intervertebral canal narrowing with manifestations of backache and radiculopathy HNPs at various interspaces (L3–L4, L4–L5, L5–S1) and with differing axial presentations (e.g., far lateral, paracentral, and central protrusion) were examined.

• Patient less than 18 years and more than 60 years.
• Back pain less than 3 months of duration.
• Patient refusal for the procedure.
• MRI scan shows a herniated nucleosus pulposus (HNP) of intervertebral disc with more than 50% intervertebral canal narrowing.
• Neurological deficit.
• Patient with history of allergy to contrast media, steroids, and local anaesthetic agents.
• Previous lumbar spine surgeries or epidural steroid injections.
• Multi-level degenerative spine disease unstable spine vertebral compression fractures, Spondylo listhesis, cauda equina syndrome and arachnoiditis.
• Patient diagnosed to have Bleeding disorders, active cancer, history of substance abuse, current psychiatric co-morbidity, pregnancy, diabetes mellitus and congestive cardiac failure.

This prospective study was approved by hospital ethical committee. Proforma was created containing patient’s history and examination of lumbar spine was noted. Patients who met inclusion criteria were admitted and obtained written and informed consent was taken in patient’s own language after explanation of all risks, benefits, purposes, and outcomes of the study. Routine blood investigations including prothrombin time, bleeding time and clotting time, X-ray Lumbar spine AP and Lateral (Flexion and Extension) view and MRI lumbar spine with whole spine screening were routinely done. Pre-anaesthetic fitness was obtained and taken up for procedure. All the patients were assessed with Patients satisfaction scale, Revised Owestry disability index (ODI), Roland Morris low back pain Disability Questionnaire (RMDQ), visual numeric pain scale, Measurement of finger-to floor distance at preprocedure, 1st week, 1st month, 3rd month, 6th month and 12th month. All the scores have been shown in annexure 2 -6. All the information data collected, at the end of the study was statistically analysed and compared with the similar studied done before.

Statistical analysis

The data was entered in Microsoft excel and analysed using Statistical Package for the Social Sciences (SPSS) software version 21. The demographic data is presented as frequencies, measures of central tendency and dispersion. Appropriate statistical tests of significance (p value and independent t test for quantitative data) are used to study the difference between pre-procedural injection and 12 months after injection. Paired t-test was applied to compare changes in functional status and pain intensity. P value of <0.05 was considered as significant.

Results

The following analysis was made after collecting data for this prospective comparative study of 50 lumbar radicular treated with epidural steroid injection patients in the Department of Orthopaedics of Sree Balaji Medical College and Hospital, Chromepet, Chennai, during the period from July 2017 to December 2019. Table 1 to Table 6 and Figure 1 to Figure 6 explained detailed results.

Table 1: Age distribution.

Table 2: Gender distribution.

Table 3: Etiology of patients.

Table 4: Distribution of radiating pain.

Table 5: Distribution of patients with duration of symptoms.

Table 6: Level of disc pathology.

Figure 1: Distribution of age groups.

Figure 2: Distribution of gender.

Figure 3: Distribution of etiology of patients.

Figure 4: Distribution of radiating pain.

Figure 5: Distribution of patients with duration of symptoms.

Figure 6: Distribution of level of pathology.

Discussion

The projected spending in USA in 1998 for back ache was $90.7 billion dollars. It was 11 billion pounds in UK in 2000 and low back ache was found to be one of the most expensive illnesses as the direct and indirect charges were assessed to be $ 9.17 billion dollars [9,10]. The management of low back ache is a challenge not mere to the orthopaedic surgeons but also for anesthesiologists in pain clinics and neurosurgeons because of its higher incidence, chronicity and hampered social and professional life of patients. Epidural steroid injections (ESI) are given because abnormal concentrations of nociceptive and inflammatory mediators around inflamed nerve lead to chemical neuro- radiculitis and corticosteroids block prostaglandin synthesis and inhibit nociceptive C-fiber conduction. Steroids classically work by the elimination of the rate limiting step by the enzyme prostaglandin A2 to release arachidonic acid from cell membranes. In this prospective study we analyse the functional outcome of epidural steroid injection for lumbar radicular pain. This case series were conducted on fifty patients of lower back ache with radicular pain, who came to our casualty or outpatient department of Orthopaedics in SREE BALAJI MEDICAL COLLEGE AND HOSPITAL, Chromepet, Chennai, during the period from JULY 2017 to DECEMBER 2019.In our study of 50 cases most of patient’s age group range from 2nd to 6th decade of life. There were thirteen (26%) patients in the group of 20 -30 years, eleven (22%) patients in the age group of 31 -40 years, thirteen (26%) patients in the group of 41 -50 years, nine (18%) patients in the group of 51 - 60 years, four (8%) patients in the age group of 61-70 years. Mean age of the patients was 41.1 years indicates peoples in this age are highly active in daily life and exposed to various physical stress. So, there is ninety two percent (92%) of working population in this study group i.e., 20 -60 year’s age group. Our study was comparable with many other studies, majority of patients were in working age population.

In the present study there was a male preponderance of 39 (78%) patients and majority of them were in 3rd to 5th decade of life. 11 (22%) patients were female, with ratio of 3.5:1 is quite differ from literature, as it says, low back pain can affect sooner (<20) or later (>60) almost everyone in life [12]. In a previous study it is concluded that male patients were highly involved in low back ache it could be due to having a job like heavy lifting, pushing or pulling and long driving.

In the present study 41(82%) patients were having symptoms for < 1year, among which 20(40%) for <6months and 21(42%) for 7-12 months, 6(12%) patients were having symptoms from 13 to 18 months, 2(4%) patients were having symptoms from 19 to 24 months, only one patient beyond 24 months, with mean duration of pain being 9.56 months [11-24].

In the present study most of the patients 18(36%) out of 50 were having bilateral radiating pain while 15(30%) out of 50 patients were had right and 17(34%) had left sided radicular pain. In our present study MRI level of disc pathology out of 50 patients, level of disc abnormality was most common level at L4-L5 in 30(60%) patients, next common level is L5 -S1 in 15(30%) and at L3 -S4 in 5 (10%) patients.

Conclusion

In our short-term study, carefully selected patients with strict selection criteria has shown that about 14% of patients required surgery after epidural steroid, 86% patients were comfortable during the follow up of one year. Hence, we conclude that epidural steroid injection: As a step prior to operative intervention in patients with lumbar IVDP and canal stenosis. A short term significant functional improvement in both statistically and clinically in IVDP patients. This method can be considered as simple, safe, effective faster relief, less expensive, nonoperative and minimally invasive treatment modality. This modality could be a definitive treatment in some patients or a intermediate treatment where surgery can be postponed for some more time. Since our’s is a shortterm study we cannot endorse for its long term success, for which a long term study is required.

Funding

No funding sources.

Ethical Approval

The study was approved by the Institutional Ethics Committee.

Conflict of Interest

The authors declare no conflict of interest.

Acknowledegements

The encouragement and support from Bharath University, Chennai is gratefully acknowledged. For provided the laboratory facilities to carry out the research work.

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