|Year : 2020 | Volume
| Issue : 2 | Page : 101-105
Comparison of clinical efficacy between dexamethasone and triamcinolone for transforaminal epidural steroid injections in the management of low back pain
Dinesh Kumar Sahu, Ajinkya Kale, Atul Sharma, Reena Parampill
Department of Anaesthesiology and Pain Management, Jagjivanram Railway Hospital, Mumbai Central, Mumbai, Maharashtra, India
|Date of Submission||12-May-2019|
|Date of Decision||10-Jul-2019|
|Date of Acceptance||29-Jun-2020|
|Date of Web Publication||06-Aug-2020|
Dr. Ajinkya Kale
Department of Aneasthesiology and Pain Management, Jagjivanram Railway Hospital, Mumbai Central, Mumbai-08, Maharashtra
Source of Support: None, Conflict of Interest: None
The objective of this study was to compare the clinical efficacy of transforaminal epidural injection of dexamethasone and triamcinolone in the management of chronic low back pain with or without radiculopathy due to herniated intervertebral disc. It was a prospective, randomized, single-blind study, conducted in eighty patients of either sex suffering from low back pain of more than 3 months duration due to herniated intervertebral disc. The patients were allocated into two groups to receive either injection dexamethasone 8 mg or injection triamcinolone acetonide 40 mg as 2 ml solution through transforaminal epidural route. Each patient underwent unilateral lumbar transforaminal epidural steroid injections (TFESIs) at one level only depending on predominant involvement of nerve root on magnetic resonance imaging computed tomography of the spine and consistent with a clinical presentation of patients. Patients in both the groups were assessed prior to epidural injection and at the 2nd, 6th, and 12th weeks following epidural injection for the intensity of pain using a numerical rating scale of 0–10 and requirement of analgesics on weekly basis. Any adverse event following epidural injection was also noted during the follow-up period of the study. Improvement in pain score was significantly better with transforaminal epidural injection of triamcinolone acetonide compared to dexamethasone, in patients with chronic low back pain due to herniated intervertebral disc. No major adverse event was reported during the follow-up period in patients of either group.
Keywords: Dexamethasone, herniated intervertebral disc, low back pain, transforaminal epidural steroid injection, triamcinolone
|How to cite this article:|
Sahu DK, Kale A, Sharma A, Parampill R. Comparison of clinical efficacy between dexamethasone and triamcinolone for transforaminal epidural steroid injections in the management of low back pain. Indian J Pain 2020;34:101-5
|How to cite this URL:|
Sahu DK, Kale A, Sharma A, Parampill R. Comparison of clinical efficacy between dexamethasone and triamcinolone for transforaminal epidural steroid injections in the management of low back pain. Indian J Pain [serial online] 2020 [cited 2020 Sep 30];34:101-5. Available from: http://www.indianjpain.org/text.asp?2020/34/2/101/291542
| Introduction|| |
The epidural corticosteroid injection has been used as a part of a comprehensive interdisciplinary approach in the management of chronic spinal pain. Injection of corticosteroids in the epidural space could reduce nociceptive signals from the irritated nerve roots presumably by inhibiting the formation and release of inflammatory cytokines, stabilizing neural membranes, and modulation of peripheral nociceptive pathway.,
Methylprednisolone, triamcinolone, and betamethasone are the particulate corticosteroid preparations conventionally used for epidural injections in the management of chronic spinal pain., However, the recent trials demonstrated the convincing efficacy of dexamethasone, a nonparticulate corticosteroid preparation for epidural injections in patients of low back pain with or without radiculopathy, with enhanced safety profile then particulate steroids.
Transforaminal epidural injection technique has the advantage of delivering the injectate under fluoroscopy guidance onto the affected nerve root at the site of the pathology, i.e., ventrolateral epidural space. The efficacy of transforaminal epidural steroid injections (TFESIs) was found to be superior to interlaminar epidural steroid injections (ESIs) in patients of lumbosacral radicular pain due to herniated intervertebral disc. However, it remained a contentious issue that the efficacy of TFESI is primarily due to the route of epidural injection or the deposition of steroid preparation near the affected nerve root.
Despite the increased efficacy of TFESI, a significant debate is continued regarding its safety. There have been several reports of catastrophic complications following lumbar TFESI. All such cases have implicated the use of particulate steroid preparations for TFESI., It was demonstrated that particulate corticosteroids aggregate to clusters that are larger than red blood cells, which could cause embolism and spinal cord infarction, if inadvertently injected into the radicular artery., Dexamethasone, on the other hand, contains no particles exceeding the diameter of red blood cells and hence could not result in embolic infarction of the spinal cord.
While there is no dispute in the greater safety profile of dexamethasone in TFESI, there remains a doubt regarding the efficiency of nonparticulate steroid preparations in comparison to particulate steroids in patients of chronic back pain.
Therefore, the present study was conducted to compare the efficacy of injection dexamethasone and triamcinolone acetonide through the transforaminal epidural route in patients of chronic low back pain with or without radiculopathy due to herniated intervertebral disc.
| Methods|| |
After obtaining due approval from Institute's Ethics Committee and written informed consent from the patients, a prospective, randomized, single-blind study was conducted in eighty patients of either sex suffering from chronic low back pain due to intervertebral disc herniation with or without radiculopathy, for more than 3 months duration. Patients were randomly divided into two groups of 40 patients each as per the computer-generated randomization table. Those in Group D received injection dexamethasone sodium phosphate 8 mg (Dexona, 4 mg per ml, Zydus Cadila Healthcare Ltd. [Alidac], India) and in Group T received injection triamcinolone acetonide 40 mg (Kenacort, 40 mg per ml, Abott Healthcare Pvt. Ltd., India).
Patients aged 25 years and older with chronic low back pain (numerical rating scale [NRS] score ≥5) for more than 3 months duration not responding to conservative therapy and imaging (magnetic resonance imaging computed tomography [CT/MRI]) of the spine showing herniated intervertebral disc with impingement of exiting nerve root were included in the study. Patients with the rapidly progressing neurological deficit, cauda equina syndrome, cognitive impairment, previous spine surgery, chronic use of steroid or anticoagulant medications, history of allergy to iodinated contrast agents, and history of spinal injection in the past 3 months; pregnant and nursing mothers; patients with local or systemic infection; and patients with comorbidities (i.e., uncontrolled hypertension, diabetes mellitus, ischemic heart disease, and hematological diseases, etc.,) were excluded from the study.
All the eligible patients were assessed at least 1 week prior to the procedure. Their baseline (preprocedure) NRS was noted and a standard treatment protocol for pain management, i.e., fixed-dose combination of oral tramadol 37.5 mg and paracetamol 325 mg (Ultracet, Janssen Pharmaceuticals, India), was advised to them, with a minimum interval of 6 h between two doses.
The TFESIs were performed in accordance with International Spine Interventional Society guidelines. On arrival to the procedure room, appropriate monitors were attached and intravenous line was secured. The patient was placed in the prone position on the C-arm compatible table and supported by a pillow under the abdomen to reduce lumbar lordosis. After sterile preparation of the area and infiltration of skin with local anesthetic (xylocaine 2%), a 22 G, 3.5-inch spinal needle was advanced in an oblique view to the safe triangle using subpedicular approach. Both anterior–posterior and lateral views were obtained to confirm precise needle placement within the intervertebral foramen (at 6 o'clock position inferior to the pedicle). Then, 0.5–1 ml of nonionic contrast agent was administered under real-time fluoroscopy to confirm the flow of injectate to the target area and absence of vascular or subdural or subarachnoid spread.
Once the correct placement of the needle was confirmed under real-time fluoroscopy, patients received the allocated steroid preparations as 2 ml solution. Patients in Group D received 8 mg (2 ml) of dexamethasone sodium phosphate 8 mg (Dexona, 4 mg per ml, Zydus Cadila Healthcare Ltd. [Alidac], India), while those in Group T received triamcinolone acetonide 40 mg (Kenacort, 40 mg per ml, Abott Healthcare Pvt. Ltd., India) diluted in 1.0 ml of normal saline. Patients in both the study groups received unilateral, single-level TFESI based on predominant involvement of nerve root on imaging (MRI/CT) of the spine and consistent with a clinical presentation of the patient.
All the patients were monitored for 4 h following epidural injection and subsequently followed by an investigator blinded to the study groups at the 2nd, 6th, and 12th weeks either through visits at pain clinic or telephonically. The primary outcome was to measure the intensity of pain using NRS of 0–10 (0 = no pain, 10 = worst imaginable pain). The secondary outcomes were the requirement of analgesics on weekly basis and adverse events following epidural injection in either group.
The sample size was calculated on the basis of study by Park et al., keeping a clinically relevant difference of 30% in pain scores between the two study groups. A sample size of 40 patients in each group was calculated with α value 0.05 and power of the study as 80%.
The data analysis was done with the help of SPSS Software version 15 (IBM corp., Armonk, NY) and SigmaPlot version 12. Quantitative data variables were presented with the help of mean and standard deviation. To compare the pain scores between and within the study groups, Mann–Whitney U-test was used. A comparison of the quantitative data between the study groups was done with the help of unpaired t-test, and intragroup analysis was done with the help of paired t-test. Chi-square test was used to compare categorical variables. P < 0.05 was considered statistically significant.
| Results|| |
Patients in both the groups were comparable with respect to their demographic profile and baseline mean pain scores (NRS) [Table 1]. The level of predominant nerve root injected was also comparable in the two study groups [Table 1].
|Table 1: Demographic parameters, baseline pain scores (numerical rating scale), and level of nerve root injected in the two study groups|
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The mean NRS scores in both the study groups were significantly improved from baseline during the follow-up period of study at 2nd, 6th and 12th week [Table 2].
|Table 2: Comparison of numerical rating scale scores between the two study groups|
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The mean NRS scores were comparable between the two study groups at the 2nd week following intervention; however, the NRS scores in the triamcinolone group were significantly lower as compared to the dexamethasone group at the 6th and 12th weeks of follow-up period [Table 2].
The requirement of rescue analgesics was significantly reduced from baseline at 2nd, 6th, and 12th week following intervention in both the study groups. Although the requirement of rescue analgesics was comparable between the two study groups at 2nd week following TFESI, there was a significant increase in the requirement of analgesics in group D as compared to group T at 6th and 12th week [Table 3].
Except minor complications such as pain at the site of injection and transient paresthesia in the lower limb in two patients in Group D and three patients in Group T, no major complication was reported in patients of either group. All these complaints were resolved within the next few days without any sequelae.
| Discussion|| |
This randomized, single-blind, controlled clinical trial conducted on 80 patients of chronic back pain with or without radiculopathy showed that TFESI provided significant improvement in pain scores and reduction in the requirement of analgesics over the study period of 12 weeks. However, the relief in back pain was significantly greater in patients who received transforaminal epidural injection of triamcinolone as compared to those who received transforaminal injection of dexamethasone at the 6th and 12th weeks of follow-up period.
Park et al. conducted a randomized, controlled trial to compare the efficacy of lumbar transforaminal epidural injection of triamcinolone (40 mg) with dexamethasone (7.5 mg) in patients of low back pain with radiculopathy. At 1 month after treatment, both the groups had significantly lower mean pain scores from their baseline, but the triamcinolone group achieved pain score that was significantly lower than that of the dexamethasone group. The proportion of patients with a greater percentage of pain relief was significantly more in the group treated with triamcinolone than dexamethasone (P = 0.000). The reduction of pain score was 40% in the dexamethasone group, while it was 71% in the triamcinolone group. We have also observed a similar trend in our study, i.e., significantly lower mean pain scores in the triamcinolone group as compared to the dexamethasone group at the 6th and 12th weeks of follow-up period following intervention.
Kennedy et al. compared triamcinolone and dexamethasone for single-level TFESI in patients of radicular pain due to lumbar disc herniation. Although patients of both the study groups had significant improvement in pain scores at 2nd week, 3rd month, and 6th month, a greater percentage of patients in the dexamethasone group underwent repeat injections than triamcinolone group, possibly due to a shorter duration or efficacy of dexamethasone as compared to triamcinolone.
El-Yahchouchi et al. conducted a retrospective observational study to assess the efficacy of dexamethasone in comparison to triamcinolone and betamethasone in TFESI in patients of lumbar radiculopathy. They reported that there was a nonsignificant trend for greater effectiveness of the particulate steroids than dexamethasone at 2 weeks post injection, but at 2 month of follow-up, no significant difference in the efficacy was found between particulate and nonparticulate steroid preparations.
Another retrospective study conducted by El-Yahchouchi et al. demonstrated that response to pain relief at 2 weeks post lumbar TFESI correlated more strongly with 2-month outcome rather than immediate post injection pain relief. We have seen a similar trend in our study also, primarily in patients who received transforaminal epidural triamcinolone rather than dexamethasone.
Manchikanti et al. demonstrated a significant relief in back pain and lower limb pain secondary to disc herniation with transforaminal epidural injections of local anesthetics with or without steroids. The efficacy of TFESI was 73%–80% in the responsive participant group, while its overall efficacy was 57%–65%. Thus, this trial provided evidence that in carefully selected patients, transforaminal epidural injections played an important role in the management of chronic back pain secondary to impingement of nerve root due to disc herniation.
Kim et al. compared the efficacy of lumbar ESIs using dexamethasone (10 mg) in 162 patients who had previously received ESI of triamcinolone (40 mg) within 1-year period. 62.6% patients reported that the effect of epidural injection of triamcinolone was better than that of epidural dexamethasone (P = 0.004). The mean duration of injection-free interval after epidural triamcinolone was significantly longer than that of epidural dexamethasone (91.5 days vs. 77.3 days). These findings were consistent with the present study where we have observed that TFESI with triamcinolone provided significantly greater pain relief than dexamethasone during 12 weeks of follow-up in patients of low back pain due to herniated intervertebral disc.
No major complication was reported in any patient in this study except transient increase in back pain and radicular pain in 2 (5%) patients in Group D and 3 (7.5%) patients in Group T following an intervention. This could be due to possible injury to the nerve root with the sharp tip of the needle during TFESI. Huston et al. reported increased radicular pain in 8.8% of the patients, while Manchikanti et al. reported increased radicular pain in 1% of the patients after TFESI.
This study is also associated with certain limitations. There is a need for a longer duration of follow-up to assess the actual difference in the duration of analgesia between transforaminal epidural injection of triamcinolone and dexamethasone in patients of chronic back pain. The study has a smaller sample size, calculated at α = 0.05, and power of 80%. A larger sample size obtained with a power of 90% could have led to more promising and precise results.
| Conclusion|| |
We conclude that transforaminal epidural injections with triamcinolone were significantly more effective than dexamethasone in patients of chronic low back pain with or without radiculopathy. No serious complication was encountered in patients of either group following transforaminal epidural injections. However; further large, randomized, double-blind, and multicentric trials are needed to establish the superior efficacy of triamcinolone than dexamethasone in transforaminal epidural injections for the management of chronic low back pain with or without radiculopathy.
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Conflicts of interest
There are no conflict of interest.
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[Table 1], [Table 2], [Table 3]