scholarly journals Tissue Distribution of Clonidine Following Intraforaminal Implantation of Biodegradable Pellets: Potential Alternative to Epidural Steroid for Radiculopathy

2012 ◽  
Vol 5;15 (5;9) ◽  
pp. E701-E710
Author(s):  
William F. McKay

Background: Epidural steroid injections have shown efficacy in short-term pain relief, but often require repeated injections in order to provide continued pain relief. It has been suggested that a continuous, locally administered dose of an anti-inflammatory compound may provide sustained pain relief at doses lower than those needed with injections. Objective: To evaluate the distribution of clonidine after transforaminal placement of a biodegradable drug delivery depot system. Study Design: A preclinical animal study. Methods: A biodegradable polymer drug depot designed to provide sustained delivery of clonidine was placed in or near a single lumbar neural foramen in 12 farm pigs. Clonidine tissue concentrations were measured at the implant site and at incremental distances from the implant over a time period of 12 weeks. Plasma clonidine levels were measured at 4 hours postimplantation on days 1, 2, 3, 5, and 7, and then weekly until the termination of the study. Results: Clonidine was detectable up to 6 cm away from the drug depot. The highest concentrations of clonidine were present within the targeted spinal nerve; the concentration decreased with increasing distance from the depot. Clonidine was undetectable in plasma from all animals at all time points. Limitations: While clonidine was detected up to 6 cm from the drug depot, it is unknown if the drug concentration has clinical relevance. Conclusions: The results indicate that a biodegradable depot designed to be placed in a specific location to provide local sustained release of an anti-inflammatory and analgesic drug may be a feasible new approach to treat radicular pain associated with intervertebral disc pathology and other spinal conditions. Key Words: clonidine, radiculopathy, pain, intraforaminal, injection, spine, sciatica

2015 ◽  
Vol 3;18 (3;5) ◽  
pp. 277-286
Author(s):  
Omar Hammam El Abd, MD

Background: Transforaminal epidural steroid injections (TFESI) are widely used for the conservative treatment of radicular pain. The use of dexamethasone in TFESIs is relatively new; therefore, immediate and acute adverse effects that it may cause are not fully updated. Objective: To evaluate immediate and acute adverse effects following TFESI with dexamethasone. Study Design: Prospective, observational study. Setting: A spine center affiliated with a rehabilitation hospital. Methods: One hundred fifty consecutive patients receiving TFESI for the management of radicular and axial spinal pain at the cervical, lumbar, and sacral levels with dexamethasone using fluoroscopic guidance with digital subtraction technology were enrolled. The occurrence of adverse effects in patients in the 2-week time period following interventions was monitored through a set of questionnaires followed up by phone calls scheduled for 1 day, day 3, and day 14. Intensity and duration of side effects were recorded. Results: Of the 150 patients enrolled, 31 patients (19.5%) experienced adverse effects within the first 30 minutes following the intervention. The most common adverse effects were numbness and tingling in the limb, which developed in 19 patients (11.95%) followed by perineal pruritus that occurred in 7 cases (4.4%). Patients also reported experiencing adverse effects within the 3 days following intervention; most complained of headaches, insomnia, hiccups, flushing, and increased radicular pain. No major complications were noted. Limitations: The sample size enrolled might be too small to perceive possible rare side effects related to the procedure. The 2-week follow-up period is a limitation for evaluating late side effects. Conclusions: This study offers provision to interventionalists that TFESI with dexamethasone when performed by experienced hands and with proper technique has minor self-limited transient adverse effects that can be easily managed. Patients should be made aware of these adverse effects and their management. Further larger studies are needed to validate the safe use of dexamethasone and the safety of transforaminal epidural injections. Key words: Transforaminal epidural steroid injection, complications, dexamethasone


2013 ◽  
Vol 5;16 (5;9) ◽  
pp. 497-511
Author(s):  
Kenneth D. Candido

Background: Transforaminal and interlaminar epidural steroid injections are commonly used interventional pain management procedures in the treatment of radicular low back pain. Even though several studies have shown that transforaminal injections provide enhanced short-term outcomes in patients with radicular and low back pain, they have also been associated with a higher incidence of unintentional intravascular injection and often dire consequences than have interlaminar injections. Objectives: We compared 2 different approaches, midline and lateral parasagittal, of lumbar interlaminar epidural steroid injection (LESI) in patients with unilateral lumbosacral radiculopathic pain. We also tested the role of concordant pressure paresthesia occurring during LESI as a prognostic factor in determining the efficacy of LESI. Study Design: Prospective, randomized, blinded study. Setting: Pain management center, part of a teaching-community hospital in a major metropolitan US city. Methods: After Institutional Review Board approval, 106 patients undergoing LESI for radicular low back pain were randomly assigned to one of 2 groups (53 patients each) based on approach: midline interlaminar (MIL) and lateral parasagittal interlaminar (PIL). Patients were asked to grade any pressure paresthesia as occurring ipsilaterally or contralaterally to their “usual and customary pain,” or in a distribution atypical of their daily pain. Other variables such as: the Oswestry Disability Index questionnaire, pain scores at rest and during movement, use of pain medications, etc. were recorded 20 minutes before the procedure, and on days 1, 7, 14, 21, 28, 60, 120, 180 and 365 after the injection. Results: Results of this study showed statistically and clinically significant pain relief in patients undergoing LESI by both the MIL and PIL approaches. Patients receiving LESI using the lateral parasagittal approach had statistically and clinically longer pain relief then patients receiving LESI via a midline approach. They also had slightly better quality of life scores and improvement in everyday functionality; they also used less pain medications than patients receiving LESI using a midline approach. Furthermore, patients in the PIL group described significantly higher rates of concordant moderate-to-severe pressure paresthesia in the distributions of their “usual and customary pain” compared to the MIL group. In addition, patients who had concordant pressure paresthesia and no discordant pressure paresthesia (i.e., “opposite side or atypical”) during interventional treatment had better and longer pain relief after LESI. Two patients from each group required discectomy surgery in the one-year observation period. Limitations: The major limitation of this study is that we did not include a transforaminal epidural steroid injection group, since that is one of the approaches still commonly used in contemporary pain practices for the treatment of low back pain with unilateral radicular pain. Conclusions: This study showed that the lateral parasagittal interlaminar approach was more effective than the midline interlaminar approach in targeting low back pain with unilateral radicular pain secondary to degenerative lumbar disc disease. It also showed that pressure paresthesia occurring ipsilaterally during an LESI correlates with pain relief and may therefore be used as a prognostic factor. Key words: lumbar epidural steroid injection, interlaminar injection, low back pain, unilateral radicular pain, midline interlaminar approach, lateral parasagittal interlaminar approach, pressure paresthesia, quality of life, everyday functionality


Author(s):  
Sang Hoon Lee ◽  
Hyun Hee Choi ◽  
Min Cheol Chang

BACKGROUND: Many patients complain of chronic cervical radicular pain, and pulsed radiofrequency (PRF) is known to have a positive effect for alleviating neuropathic pain. OBJECTIVES: In the present study, we used ultrasound (US) guidance and compared the effects of monopolar PRF with those of bipolar PRF in patients with chronic cervical radicular pain refractory to repeated transforaminal epidural steroid injections. METHODS: Sixty-six patients with chronic cervical radicular pain were included in this study. Patients were randomly assigned to one of the two groups: monopolar or bipolar PRF group (n= 33 per group). Pain intensity was evaluated using a numeric rating scale (NRS) at pretreatment, and at 1 and 3 months after the treatment. Target stimulation site was the extraforaminal nerve root. RESULTS: Compared to the pretreatment NRS scores, patients in both groups showed a significant decrease in NRS scores at 1 and 3 months after the treatment. Reductions in the NRS scores over time were significantly larger in the bipolar PRF group. Three months after the treatment, 18 patients (54.5%) in the monopolar PRF group and 27 (81.8%) in the bipolar PRF group reported successful pain relief (pain relief of ⩾50%). CONCLUSIONS: US-guided PRF can be an effective interventional technique for the management of chronic refractory cervical radiculopathy. Moreover, bipolar PRF has better treatment outcome than monopolar PRF.


2015 ◽  
Vol 6;18 (6;11) ◽  
pp. E519-E525
Author(s):  
Hahck Soo Park

Background: There have been many studies proving the effectiveness of lumbar transforaminal epidural steroid injections (TFESIs) for the treatment of radicular pain. Dexamethasone has been suggested as an alternative to particulate steroids. However, no controlled trials have investigated the effect of different injected volumes for a same dose of dexamethasone. Objective: To compare the effects of a high-volume injectate with those of a low-volume injectate using the same dose of dexamethasone for 2 groups in lumbar TFESI. Study Design: A prospective, randomized, active control trial. Setting: The outpatient clinic of a single academic medical center. Methods: A total of 66 patients were randomized to receive lumbar transforaminal epidural dexamethasone injections with either a low-volume injectate (3mL, N = 30) or a high-volume injectate (8mL, N = 32). The primary outcome measures for this study were the incidence of the patients achieving meaningful pain relief and a reduction on the Visual Analogue Scale (VAS, range 0 – 100) at 4 weeks after the procedure. The definition of “meaningful pain relief” was ≥ 50% from baseline. The secondary outcomes included the Roland-Morris Disability Questionnaire (RMDQ, range 0 – 24) score and adverse effects. The outcomes were assessed 4 weeks after the procedure. Results: Four weeks after the procedure, in the DL8 group, the incidence of achieving meaningful pain relief was higher compared with DL3 group (19, 59.4% vs. 9, 30%, P = 0.024). Both groups demonstrated a significant improvement in their VAS and RMDQ scores (P < 0.05). The VAS of the high-volume injectate group (DL8) was significantly lower than that of the low-volume injectate group (DL3) (33.3 ± 25 vs. 46.3 ± 25, P = 0.036). There was no significant difference in the RMDQ score between the 2 groups. Limitations: We enrolled a small number of patients and did not assess the long-term outcomes. Conclusions: Injectate at a volume of 8 mL was more effective than injectate at a volume of 3 mL for radicular pain in a lumbar transforaminal steroid injection, although both of the injectates contained the same dose of dexamethasone. Key words: Dexamethasone, disc herniation, epidural injection, lumbar, radiculopathy


2018 ◽  
Vol 100-B (10) ◽  
pp. 1364-1371 ◽  
Author(s):  
H. Joswig ◽  
A. Neff ◽  
C. Ruppert ◽  
G. Hildebrandt ◽  
M. N. Stienen

AimsThe aim of this study was to determine the efficacy of repeat epidural steroid injections as a form of treatment for patients with insufficiently controlled or recurrent radicular pain due to a lumbar or cervical disc herniation.Patients and MethodsA cohort of 102 patients was prospectively followed, after an epidural steroid injection for radicular symptoms due to lumbar disc herniation, in 57 patients, and cervical disc herniation, in 45 patients. Those patients with persistent pain who requested a second injection were prospectively followed for one year. Radicular and local pain were assessed on a visual analogue scale (VAS), functional outcome with the Oswestry Disability Index (ODI) or the Neck Pain and Disability Index (NPAD), as well as health-related quality of life (HRQoL) using the 12-Item Short-Form Health Survey questionnaire (SF-12).ResultsA second injection was performed in 17 patients (29.8%) with lumbar herniation and seven (15.6%) with cervical herniation at a mean of 65.3 days (sd 46.5) and 47 days (sd 37.2), respectively, after the initial injection. All but one patient, who underwent lumbar microdiscectomy, responded satisfactorily with a mean VAS for leg pain of 8.8 mm (sd 10.3) and a mean VAS for arm pain of 6.3 mm (sd 9) one year after the second injection, respectively. Similarly, functional outcome and HRQoL were improved significantly from the baseline scores: mean ODI, 12.3 (sd 12.4; p < 0.001); mean NPAD, 19.3 (sd 24.3; p = 0.041); mean SF-12 physical component summary (PCS) in lumbar herniation, 46.8 (sd 7.7; p < 0.001); mean SF-12 PCS in cervical herniation, 43 (sd 6.8; p = 0.103).ConclusionRepeat steroid injections are a justifiable form of treatment in symptomatic patients with lumbar or cervical disc herniation whose symptoms are not satisfactorily relieved after the first injection. Cite this article: Bone Joint J 2018;100-B:1364–71.


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