Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2021 | Month : September | Volume : 15 | Issue : 9 | Page : KC06 - KC09 Full Version

Transforaminal Epidural Injection of Dexamethasone vs Methylprednisolone in Reducing Low Back Pain and Disability in Prolapsed Lumbar Intervertebral Disc in Manipur, India: A RCT


Published: September 1, 2021 | DOI: https://doi.org/10.7860/JCDR/2021/48704.15370
Kanti Rajkumari, Akoijam Joy Singh, Longjam Nilachandra Singh, Margaret Chabungbam, C Sreejith, Moirangthem Janet, Monica Moirangthem, Tasso Opo

1. Senior Resident, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India. 2. Professor, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India. 3. Associate Professor, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India. 4. Senior Resident, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India. 5. Postgraduate Trainee, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India. 6. Postgraduate Trainee, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India. 7. Postgraduate Trainee, Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India. 8. Postgraduate Trainee, Dep

Correspondence Address :
Dr. Akoijam Joy Singh,
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal-795004, Manipur, India.
E-mail: joyakoijam2@yahoo.com

Abstract

Introduction: Treatment for Low Back Pain (LBP) due to Prolapsed Intervertebral Disc (PIVD) includes conservative management, Epidural Steroid Injection (ESI), and surgery. Transforaminal Epidural Steroid Injection (TFESI) is a more recently described approach. All corticosteroid preparations used for TFESI are particulate except dexamethasone and betamethasone sodium phosphate. But while comparing methylprednisolone with dexamethasone, the latter has more potent anti-inflammatory action with least likelihood of causing embolic events and is also less expensive.

Aim: To compare the efficacy of transforaminal epidural injection of dexamethasone and methylprednisolone in reducing LBP and disability in prolapsed lumbar intervertebral disc amongst the indigenous population of Manipur, India.

Materials and Methods: This was a randomised controlled study on 80 patients with PIVD attending Outpatient Department (OPD) at physical medicine and rehabilitation was conducted from September 2016 to August 2018. A single dose of lumbar TFESI with dexamethasone in the study group and methylprednisolone in the control were given under C-arm guidance. The outcome variables Visual Analog Scale (VAS) for pain and Oswestry Disability Index (ODI) for function were measured at one week, one month and six months. Statistical tests like t-test, Chi-square test were used for intra group and inter group analysis.

Results: In the total sample of 80 patients, 40 (15 males and 25 females, mean age: 38.28±8.55 years) were categorised as Dexamethasone patients and 40 (17 males and 23 females; mean age: 39.28±7.80 years) as methylprednisolone patients, there were significant improvement in mean score of VAS and ODI in both the groups (p-value <0.05). At six months, both treatment groups maintained initial observed improvements, with no significant differences between groups on the VAS {95% Confidence Interval (CI), -0.02 to 0.4; p-value=0.07} and ODI (95% CI,-0.21 to 3.43; p-value=0.08).

Conclusion: Non-particulate steroid dexamethasone was similar in efficacy to the particulate steroid methylprednisolone in lumbar TFESI. However, in view of the greater safety profile of dexamethasone, it is suggested that dexamethasone may be used as the preferred agent in lumbar TFESI.

Keywords

Functional improvement, Oswestry disability index, Steroids, Visual analog scale

Lumbar prolapsed disc causes impairment of function by nerve root compression, compelling the patient to seek medical advice for low backache and leg pain (1).The problem of LBP due to PIVD is fairly common in Manipur because the inhabitants are subjected to various physical stress either due to their living habits, low socio-economic status or are subjected to live or work at places with poor infrastructure (2). In Manipur, LBP contributes to 16% of musculoskeletal complaints (community oriented program for control of rheumatic diseases- COPCORD 2008) (3). Lifetime prevalence of LBP is as high as 84% (4). The 2010 Global Burden of Disease Study estimated that LBP is among the top ten diseases and injuries that account for the highest number of disability adjusted life years worldwide (5).

The causes of LBP and radiating leg pain are complex. Initially, prolapsed disc was believed to cause pain by mechanically compressing the nerve roots. Now, it is well known that leakage of the contents of the nucleus pulposus, causes pain producing inflammatory reaction in the disc itself, around the facet joint and a chemical neuroradiculitis due to the synthesis of various inflammatory mediators like phospholipase A2, Tumor Necrosis Factor (TNF)-α, Interleukin (IL)-6, IL-8, and Glycoprotein G (GG) E2 (1). Corticosteroids are believed to decrease pain by reducing inflammation through inhibition of phospholipase A2 activity and by blocking the transmission of nociceptive C-fiber input (6). The ESI is the most effective for lumbosacral radiculopathy associated with intervertebral disc herniation, bulging, or degeneration.

A comprehensive review has demonstrated the benefits of TFESI: functional improvement, avoidance of surgery, and cost savings (7) and has been a preferred method in treatment of radiating pain from disc herniation because it had the ability to place medication directly around the inflamed nerve root and dorsal root ganglion (8).

Commonly used corticosteroids in ESI include dexamethasone, betamethasone, methylprednisolone and triamcinolone. All corticosteroid preparations used for epidural injection are particulate except dexamethasone and betamethasone sodium phosphate (9). Particulate corticosteroids are poorly soluble in water whereas dexamethasone sodium phosphate is considered as freely water soluble and soluble steroids are rapidly cleared, theoretically resulting in a short duration of action and less effective than a particulate corticosteroid (10). Given the short duration of action of dexamethasone, some clinicians view particulate corticosteroids as more appropriate therapeutic choices. Accidental intra-arterial injection of particulates can cause spinal cord infarction (11). A non-particulate steroid is likely safer and in theory should not result in embolic infarction of the spinal cord. While there are studies of dexamethasone use for the cervical region (12),(13),(14), there are only a few studies of its use in the lumbar region (15),(16) and has not been implicated in any of the embolic events associated with epidural injection (17).

As compared to methylprednisolone, the pharmacological property of dexamethasone as a potent anti-inflammatory, least likelihood of causing embolic events and being less costly contemplated the authors to conduct a study with an aim to assess the clinical results, with regard to decreasing pain and disability, of TFESI of dexamethasone and methylprednisolone in PIVD.

Material and Methods

A randomised controlled trial on 80 patients with PIVD attending OPD at Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal was conducted from September 2016 to August 2018. Approval from the Research Ethics Board, RIMS, Imphal was taken before the start of the study {A/206/REB-Comm(SP)/RIMS/2015/187/55/2016} and written informed consent was obtained from all the subjects.

Sample size calculation: Taking into consideration from the study conducted by Kim D and Brown J, a prior power calculation was conducted and found that a sample size of 80 subjects was needed to detect between-group mean differences in an overall comparison between transforaminal methylprednisolone and dexamethasone (18).

Inclusion criteria: Patients with prolapsed lumbar disc L4-L5 and L5-S1 less than three months duration, confirmed by MRI (Grade II and III) (19), 20 to 55 years, with Visual Analogue Scale (VAS) ≥5, Oswestry Disability Index (ODI) (20) score >40 and willingness to comply with treatment and follow-up assessments were included in the study.

Exclusion criteria: Patients with cauda equina syndrome, mental or physical condition that would invalidate evaluation results, prior lumbar surgery at any level, patients scheduled to have more than one level of steroid injection, pregnant patients, patients with systemic or local infection at site of injection, known allergy to corticosteroids, contrast dye or anesthetics, history of malignancy, bleeding disorders, uncontrolled diabetes mellitus/hypertension, patients who received any spinal injection in the past three months were excluded from the study.

Patients were assigned to two groups (Group A and B) by using block randomisation technique. Group A (Study Group) received Inj. Dexamethasone sodium phosphate 16 mg transforaminal epidural injection and group B (Control Group) received Inj. Methylprednisolone acetate 80 mg transforaminal epidural injection. The participants and physician who conducted follow-up were blinded to the treatment received (Table/Fig 1).

Interventions

Patient was placed in a prone position with a pillow under the abdomen to reduce lumbar lordosis. Using an ipsilateral oblique view, the X-ray tube (source) of the C-arm fluoroscope was angulated to square the inferior endplate of the vertebral body, and to place the superior articular process of the subjacent segment pointing at 6 o’clock of the pedicle of the above level that appears as a Scottie dog eye. Local skin was then prepped and draped in a sterile manner. A local skin wheal was raised with 1% lidocaine at the needle entry site and the subcutaneous tissue in the needle trajectory path infiltrated with 1% lidocaine. A 22 gauge spinal needle of appropriate length was inserted and directed down and parallel to the fluoroscopic beam toward the “safe triangle.” To avoid deep needle placement and injury to the neurovascular structures in foramen, the needle was advanced until the tip touched the lower edge of the Scottie dog eye. The needle was then slightly withdrawn for 2 to 3 mm and redirected inferiorly just under the lower edge of the transverse process for about 0.5 mm. Further advancement of the needle was done under antero-posterior (AP) and lateral views. The final needle tip position was at the posterior half of the neuroforamen just under the pedicle in the lateral view to minimize injury to the neurovasculature structure. For the L5-S1 foramen, the C-arm source often needs to be tilted in a caudal direction to accommodate any remaining lumbar lordosis. An ipsilateral oblique projection was then used to visualise the Scottie dog and the target was identified as the region immediately under the pedicle, slightly lateral to the 6 o’clock position. This position leads to needle placement in the neuroforamen, ventral to the nerve root. Lateral imaging was used to demonstrate the needle depth, which was located at the superior portion of the intervertebral foramen, just under the pedicle. Once the needle was deemed at the proper position, approximately 1.0 mL of the contrast was injected under live fluoroscopic view. The needle was redirected if there was vascular uptake of the contrast. The injected contrast ideally outlined the nerve root and also show epidural spread.

For group A, 16 mg of Dexamethasone Sodium Phosphate, and for group B, 80 mg of Methylprednisolone Acetate, was slowly injected into the neuroforamen through the spinal needle.

Measures

Pain measured by VAS and functional disability measured by ODI were the outcome measures. Outcome variables were measured at baseline before intervention, one week, one month and six months. Paracetamol was given as rescue drug. Patients in both the groups received lumbar core muscles strengthening exercise and directions to engage in activity as tolerated.

Statistical Analysis

Data analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. Descriptive analysis including mean, percentage, standard deviation, confidence intervals were used. Paired t-test and chi-square test were used for significant test. Value of p<0.05 was considered to be statistically significant.

Results

The present study analysed a total of 80 subjects (40 in Dexmethasone group and 40 in Methylprednisolone group) and the data was collected and results were tabulated. (Table/Fig 2) shows that there were no statistical differences in the baseline characteristics between the dexamethasone and methylprednisolone groups (p>0.05).

(Table/Fig 3), (Table/Fig 4) show significant improvement in both mean VAS scores and ODI scores at one week, one month and six months of follow-up in both the groups. The comparison of mean within same group was compared using paired t-test (p-value <0.05).

There was no statistically significant difference in terms of pain relief and improvement in functional disability between the two groups (p-value >0.05). At six months, both treatment groups maintained initial observed improvements, with no significant differences between groups on the VAS (95% CI, -0.02 to 0.42; p=0.07) and ODI (95% CI,-0.21 to 3.43; p=0.08) (Table/Fig 5).

Twelve (15%) patients complained of pain at the injection site for a few days (mean duration 1.6 days, with a range of 0.4-3 days), 4 in dexamethasone group and 8 in methylprednisolone group. Three (3.75%) patients complained of headache after the injection, 1 in dexamethasone group and 2 in methylprednisolone group, but did not require medication for the same. Five patients reported mild nausea and giddiness, 2 in dexamethasone group and 3 in methylprednisolone group.

Discussion

Lumbar ESI is one of the most commonly done interventional procedures for managing back and leg pain (21). Indications for ESI include LBP associated with radicular symptoms, failure of medications, therapy and rest with persistence of functionally limiting back and leg pain, advanced imaging studies demonstrating nerve root compression with clinical correlation or physical examination findings consistent with nerve root irritation (i.e., positive dural tension signs and/or evidence of neurologic deficits) (21).

With this background, the present study was conducted on 79 patients with lumbar disc prolpase. The study revealed that mean age of the study population groups were 38.28±8.55 years in dexamethasone group and 39.28±7.80 years in methylprednisolone group. This is in par with a study of Tiwari RR et al., which claimed that age ≥35 years was found to have more risk to develop LBP (22). This may be due to decrease in the elasticity of ligaments with advancing age resulting in decrease flexibility of vertebral column (23). In the present study, there was significant improvement in VAS and ODI mean scores in a parallel pattern in both the groups at one week, one month and six months follow up (p<0.05). This is because as pain improved, patients were able to involve in daily activities without any disability.

Regarding gender, females (60%) were more commonly affected than men (40%) and among females housewives were most affected (60.4%). This finding is similar to a study conducted by Gupta G and Nandini N, of which 83% housewives were affected by LBP (23).

On comparing the two groups, no significant differences were noted with respect to either pain or functional improvement (p>0.05). This corroborates the existing literature as most studies show no statistically significant difference in outcomes between dexamethasone and particulate corticosteroids, although many have trends favouring particulate corticosteroids (18),(24), but the study by Park CH et al., reported a statistically significant result (24). In fact, from (Table/Fig 4), it is apparent that the vast majority of subjects had near complete pain relief by six months thereby clarifying that there is no indication for a routine series of three injections or multilevel injections for single disc herniation. However, in a study conducted by Kennedy DJ et al., it was found that dexamethasone possesses similar effectiveness when compared with triamcinolone but the dexamethasone group received slightly more injections than the triamcinolone group to achieve the same outcome (25).

The ultimate question when determining the ideal corticosteroid preparation is based on a risk to benefit calculation for a given patient and society as a whole. Methylprednisolone, with an intermediate duration of action, has sodium retaining potency half of cortisol and anti-inflammatory potency five times more. Dexamethasone has a long duration of action with higher anti-inflammatory and glucocorticoid potency as compared to other steroids. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium retaining property of hydrocortisone. Also, dexamethasone is very cheap compared to methylprednisolone. Methylprednisolone has uniformly sized, densely packed particles with >50 μm in diameter and may form aggregations. Dexamethasone has particulate size <5 μm with the lowest density and the least tendency to aggregation among all the steroid preparations (26). Theoretically, dexamethasone should have minimal neurological sequelae and a short duration of action (26). Total dose should not exceed 3 mg/kg or 210 mg/year of methylprednisolone and equipotent doses of other steroids. Beyond this dosage, water and salt retention can occur (16). None of the patients received steroid exceeding this dose. Particulate corticosteroids were regarded as more suitable for therapeutic options because it was theorised that particulate steroid preparations may provide a local depot effect with constant release of the active drug from the administration site over a longer time period compared to non-particulate steroids (27).

Natural history of disc prolapse varies and so lack of long-term follow-up is one limitation in this study. Many studies reported short-term pain relief at 2-4 weeks and conflicting results in pain scores and operation rates by 12 months (26),(28). Also, plasma levels of steroid as well as evidence of suppression of the hypothalamo-pituitary-adrenal axis were not estimated. However, clinically there was no evidence of suppression or over-dosage of steroid.

Very few patients complained of pain at the injection site, headache, mild nausea and giddiness for a few days. There was no incidence of epidural haematoma, intravascular injection, nerve root injury or meningitis. To generalise the findings, this study showed that the non-particulate steroid dexamethasone was similar in efficacy to the particulate steroid methylprednisolone in lumbar TFESI in the management of herniated discs.

Limitation(s)

Lack of long-term follow-up is one limitation in this study. Also, plasma levels of steroid as well as evidence of suppression of the hypothalamo-pituitary-adrenal axis were not estimated. However, clinically there was no evidence of suppression or over-dosage of steroid.

Conclusion

There is no statistically significant difference between transforaminal dexamethasone and methylprednisolone injection in reducing pain and disability in prolapsed lumbar intervertebral disc amongst the indigenous population of Manipur, India. However, in view of the greater safety profile of dexamethasone, it is suggested that dexamethasone may be used as the preferred agent in lumbar TFESI in the management of herniated discs.

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DOI and Others

10.7860/JCDR/2021/48704.15370

Date of Submission: Jan 26, 2021
Date of Peer Review: Mar 18, 2021
Date of Acceptance: Jun 24, 2021
Date of Publishing: Sep 01, 2021

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jan 28, 2021
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• iThenticate Software: Jul 23, 2021 (20%)

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