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Efficacy of interlaminar vs transforaminal epidural steroid injection for the treatment of chronic unilateral radicular pain: prospective, randomized study.

Authors Rados I , Sakic K , Fingler M , Kapural L
Journal Pain medicine (Malden, Mass.)
Year 2011
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This article is included in 4 Systematic reviews Systematic reviews (4 references) 1 Broad synthesis Broad syntheses (1 reference)

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UNLABELLED: OBJECTIVE, DESIGN AND SETTINGS: The purpose of this randomized, prospective study is to compare the efficacy of two different routes in administering epidural steroid injections interlaminar (IL) vs transforaminal (TF) in patients with unilateral radicular pain. PATIENTS: We randomly enrolled and followed 64 patients with chronic radiculopathy. RESULTS: Significant improvements were maintained throughout 6 months (24 weeks) of follow-up (P<0.001, respectively). The average visual analog scale (VAS) pain scores at 24 weeks improved to 4.0 ± 2.2 cm in the IL group and 3.8 ± 2.1 cm in the TF group (P=0.717). Baseline functional capacity was comparable for the IL and the TF group (52% vs 53%) when assessed using Oswestry (P=0.647). At 6 months, both groups improved, 39% for the IL group and 38% for the TF group, suggesting change from severe to moderate disability scoring range. There were 24 out of the 32 (75%) patients in the IL group at 24 weeks who improved more than 2 cm on the VAS scale and 17 patients (53%) had >50% of the pain relief. In the TF group, there were 27 out of the 32 (84%) patients with >2 cm improvement on VAS pain scale, and 20 of 32 (63%) with >50% improvement at 24 weeks. Functional capacity changes were similar, 16 out of the 32 patients (50%) improved 10 points or more on the Oswestry scale in the IL group and 21 out of the 32 in the TF group (66%). CONCLUSIONS: Using either route of epidural injections to deliver steroids for unilateral chronic radiculopathy secondary to herniated intervertebral disc provided significant improvements in patients function and pain relief. However, we could not find a statistically significant difference between two indicated groups either in functional improvement or in reduction in pain, although half-dose of steroids delivered via TF route provided somewhat better long-term pain relief and functional capacity improvements.

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Prognostic usefulness of high sensitivity C-reactive protein for transforaminal epidural steroid injection in patients with radicular pain.

Authors Park CH , Lee SH
Journal Pain medicine (Malden, Mass.)
Year 2011
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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OBJECTIVE: There are several types of lumbar stenosis, such as central, lateral recess, foraminal. The symptoms of lumbar stenosis are neurogenic claudication, numbness, tingling, etc. The treatment modality is medication, physical therapy, intervention, and surgery. The epidural steroid injection has been used for treatment of low back pain/radiculopathy. However, we could not predict what percent had pain relief after epidural steroid injection. The purpose of this study was to evaluate the usefulness of high sensitivity C-reactive protein (hsCRP) as a marker for predicting the efficacy of lumbar transforaminal epidural steroid injection. DESIGN: A total of 55 patients with lumbar stenosis underwent lumbar transforaminal epidural steroid injection under fluoroscopic guidance. Prior to injection, all patients were examined and their visual analog scale (VAS) score and hsCRP score were recorded. They returned 4 weeks following their initial injection and repeat hsCRP, and VAS sores were obtained. RESULTS: The average pretreatment hsCRP and VAS score for all 55 patients were 3.2±4.3 mg/L and 8.1±1.1, respectively. Forty-two of 55 patients had 1.6 mg/L of hsCRP. After procedure, the VAS decreased from 8.0±1.1 to 2.5±1.1. In contrast, the averages of hsCRP and VAS scores of 13 patients were 9.4±3.7 mg/L and 8.2±0.9, respectively, at baseline, which decreased to 1.2±0.9 mg/L and 2.5±0.8 at 4 weeks later. At posttreatment, the VAS score difference between the two groups was not statistically significant. There was no correlation between hsCRP and VAS score (P=0.426). CONCLUSION: The results suggest that there was no correlation between pretreat hsCRP and posttreat VAS. Therefore, hsCRP may not be useful as predictor of response to TFESI in patients with spinal stenosis.

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Transforaminal epidural clonidine versus corticosteroid for acute lumbosacral radiculopathy due to intervertebral disc herniation.

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Journal Spine
Year 2011
Links Pubmed DOI PubMed Central

This article is included in 1 Systematic review Systematic reviews (1 reference)

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STUDY DESIGN: Randomized, double-blinded trial clinical trial. OBJECTIVE: To compare efficacies of 2 active therapies for chronic low back pain. SUMMARY OF BACKGROUND DATA: Radicular pain may result from intervertebral disk herniation (IDH). Clonidine has demonstrated analgesic and antiinflammatory activity in animal studies of nerve injury. Extensive clinical experience supports neuraxial clonidine's safety. METHODS: Patients with ˜3 months of low back and leg pain due to IDH were randomized to transforaminal epidural (TFE) injection(s) of 2% lidocaine and either clonidine (200 or 400mcg) or triamcinolone (40mg). Patients received 1- 3 injections administered about 2 weeks apart. Patients, investigators and study coordinators were blinded to treatment. Primary outcome was 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 1 month. Other outcomes included Patient Global Impression of Change (PGIC), and functional measures. RESULTS: Thirty-three patients were screened and randomized. Twenty-six patients enrolled; 11 received clonidine and 15 triamcinolone. Both groups showed significant improvement in pain score at 2 weeks and 1 month compared to baseline (p< 0.05). The corticosteroid group showed additional functional improvement at 1 month relative to clonidine (p=0.022). There was no difference between groups for primary outcome. However, as target enrollment was not reached, we cannot say with confidence that the 2 treatments would be expected to result in similar short-term pain relief. Side-effects were common in both groups, but there were no serious complications. CONCLUSIONS: Radicular pain due to IDH improved rapidly with TFE injection of either clonidine or triamcinolone. Corticosteroid resulted in greater functional improvement, with unclear differences in analgesia. Future studies will determine if clonidine is superior to placebo and of particular use in those at risk for corticosteroid complications.

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Plasma disc decompression for contained cervical disc herniation: a randomized, controlled trial.

Authors Cesaroni A , Nardi PV
Journal European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Year 2010
Links Pubmed DOI PubMed Central

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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Prospective case series studies have shown that plasma disc decompression (PDD) using the COBLATION SpineWand device (ArthroCare Corporation, Austin, TX) is effective for decompressing the disc nucleus in symptomatic contained cervical disc herniations. This prospective, randomized controlled clinical trial was conducted to evaluate the clinical outcomes of percutaneous PDD as compared to conservative care (CC) through 1 year. Patients (n = 115) had neck/arm pain &gt;50 on the visual analog scale (VAS) pain scale and had failed at least 30 days of failed CC. Patients were randomly assigned to receive either PDD (n = 62) or CC (n = 58). Clinical outcome was determined by VAS pain score, neck disability index (NDI) score, and SF-36 health survey, collected at 6 weeks, 3 months, 6 months, and 1 year. The PDD group had significantly lower VAS pain scores at all follow-up time points (PDD vs. CC: 6 weeks, -46.87 +/- 2.71 vs. -15.26 +/- 1.97; 3 months, -53.16 +/- 2.74 vs. -30.45 +/- 2.59; 6 months, -56.22 +/- 2.63 vs. -40.26 +/- 2.56; 1 year, -65.73 +/- 2.24 vs. -36.45 +/- 2.86; GEE, P &lt; 0.0001). PDD patients also had significant NDI score improvement over baseline when compared to CC patients at the 6 weeks (PDD vs. CC: -9.15 +/- 1.06 vs. -4.61 +/- 0.53, P &lt; 0.0001) and 1 year (PDD vs. CC: -16.70 +/- 0.29 vs. -12.40 +/- 1.26, P = 0.005) follow-ups. PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year (PDD vs. CC: 8.86 + 8.04 vs. 4.24 +/- 3.79, P = 0.0004; 17.64 +/- 10.37 vs. 10.50 +/- 10.6, P = 0.0003, respectively). In patients who had neck/arm pain due to a contained cervical disc herniation, PDD was associated with significantly better clinical outcomes than a CC regimen. At 1 year, CC patients appeared to suffer a "relapse, showing signs of decline in most measurements, whereas PDD patients showed continued stable improvement.

Primary study

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Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial.

Journal Journal of neurosurgery. Spine
Year 2010
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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<b>Object: </b>Patients with radiculopathy, with or without back pain, often do not respond to conservative care and may be considered for epidural steroid injection therapy or a disc decompression procedure. Plasma disc decompression (PDD) using the Coblation SpineWand device is a percutaneous, minimally invasive interventional procedure. The purpose of this study was to evaluate clinical outcomes with PDD as compared with standard care using fluoroscopy-guided transforaminal epidural steroid injection (TFESI) over the course of 2 years. <b>METHODS: </b>This was a multicenter randomized controlled clinical study. Ninety patients (18-66 years old) who had sciatica (visual analog scale score &gt; or = 50) associated with a single-level lumbar contained disc herniation were enrolled. In all cases, their condition was refractory to initial conservative care and 1 epidural steroid injection had failed. Participants were randomly assigned to receive either PDD (46 patients) or TFESI (44 patients, up to 2 injections). <b>RESULTS: </b>The patients in the PDD Group had significantly greater reduction in leg pain scores and significantly improved Oswestry Disability Index and 36-Item Short Form Health Survey ([SF-36], physical function, bodily pain, social function, and physical components summary) scores than those in the TFESI Group. During the 2-year follow-up, 25 (56%) of the patients in the PDD Group and 11 (28%) of those in the TFESI Group remained free from having a secondary procedure following the study procedure (log-rank p = 0.02). A significantly higher percentage of patients in the PDD Group showed minimum clinically important change in scores for leg and back pain and SF-36 scores that exceeded literature-based minimum clinically important changes. Procedure-related adverse events, including injection site pain, increased leg or back pain, weakness, and lightheadedness, were observed in 5 patients in the PDD Group (7 events) and 7 in the TFESI Group (14 events). <b>CONCLUSIONS: </b>In study patients who had radicular pain associated with a contained lumbar disc herniation, those patients treated with PDD had significantly reduced pain and better quality of life scores than those treated using repeated TFESI. In addition, significantly more PDD patients than TFESI patients avoided having to undergo a secondary procedure during the 2-year study follow-up.

Primary study

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The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain.

Authors Ghahreman A , Ferch R , Bogduk N
Journal Pain medicine (Malden, Mass.)
Year 2010
Links Pubmed DOI

This article is included in 6 Systematic reviews Systematic reviews (6 references)

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BACKGROUND: Transforaminal injection of steroids is used to treat lumbar radicular pain. Not known is whether the route of injection or the agent injected is significant. STUDY DESIGN: A prospective, randomized study compared the outcomes of transforaminal injection of steroid and local anesthetic, local anesthetic alone, or normal saline, and intramuscular injection of steroid or normal saline. Patients and outcome evaluators were blinded as to agent administered. METHODS: The primary outcome measure was the proportion of patients who achieved complete relief of pain, or at least 50% relief, at 1 month after treatment. Secondary outcome measures were function, disability, patient-specified functional outcomes, use of other health care, and duration of relief beyond 1 month. RESULTS: A significantly greater proportion of patients treated with transforaminal injection of steroid (54%) achieved relief of pain than did patients treated with transforaminal injection of local anesthetic (7%) or transforaminal injection of saline (19%), intramuscular steroids (21%), or intramuscular saline (13%). Relief of pain was corroborated by significant improvements in function and disability, and reductions in use of other health care. Outcomes were equivalent for patients with acute or chronic radicular pain. Over time, the number of patients who maintained relief diminished. Only some maintained relief beyond 12 months. The proportions of patients doing so were not significantly different statistically between groups. DISCUSSION: Transforaminal injection of steroids is effective only in a proportion of patients. Its superiority over other injections is obscured when group data are compared but emerges when categorical outcomes are calculated. Over time, the proportion of patients with maintained responses diminishes.

Primary study

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Comparison of the Effectiveness of Lumbar Transforaminal Epidural Injection with Particulate and Nonparticulate Corticosteroids in Lumbar Radiating Pain

Authors Park CH , Lee SH , Kim BI
Journal Pain medicine (Malden, Mass.)
Year 2010
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Objective. Lumbar transforaminal epidural steroid injections are procedures often utilized in the treatment of low back pain associated with radicular pain. Particulate steroids have been known to play a role in embolism. It is, unknown whether nonparticulate steroids are as effective as particulate steroids. To investigate the effect of an epidural steroid injection on back pain, we conducted a randomized, controlled trial comparing nonparticulate steroid with particulate steroid to treat lumbar disc herniation.Design. One hundred-six patients were randomized to receive lumbar transforaminal epidural steroid injections (N = 53) with either dexamethasone 7.5mg, or with triamcinolone acetate 40mg (N=53). Measurement were taken before treatment and one month after treatment using a visual analog scale, short McGill pain questionnaire, and revised Oswertry Back Disability Index.Results. There was a statistically significant difference in the visual analog score between those treated with dexamethasone and those given triamcinolone. The two groups did not differ significantly on the McGill Pain Questionnaire, or the Oswestry Disability Index before and after treatment.Conclusion. In this study, dexamethasone and triamcinolone treatments were shown to have different effects on low back pain with sciatica, with triamcinolone being more effective than dexamethsone in lumbar radiculopathy. © 2010 Wiley Periodicals, Inc.

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Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: Clinical and radiographic results of a randomized, controlled, clinical trial

Journal Spine
Year 2009
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This article is included in 7 Systematic reviews Systematic reviews (7 references)

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STUDY DESIGN. A prospective, randomized, multicenter study of surgical treatment of cervical disc disease. OBJECTIVE. To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up. SUMMARY OF BACKGROUND DATA. Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success. METHODS. We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery. RESULTS. Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequentto the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015). CONCLUSION. Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease. © 2009 Lippincott Williams & Wilkins, Inc.

Primary study

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Percutaneous cervical disc decompression

Authors Birnbaum K
Journal Surgical and radiologic anatomy : SRA
Year 2009
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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Background: Cervical disc nucleoplasty is a significant and clinically demonstrated innovation in percutaneous disc decompression in case of non-herniated disc protrusions or prolpase. It allows a percutaneous decompression via a 19-gauge needle under utilization of the Coblation® technique and under C-arm control. Until now the patients suffering of a cervicobrachialgia in cause of a disc prolapse had only the therapeutical solution between conservative treatment and monosegmental spondylodesis or disc prosthesis of the mentioned motion segment. Methods: We wanted to demonstrate a new and practicable anatomical pathway for reaching the cervical disc prolapse comparable to the technique for discography of the cervical spine. The introducer needle is advanced into the disc under fluoroscopic guidance using a standard anterior - lateral approach. The controller delivers radiofrequency energy to quickly ablate tissue at temperatures between 50° and 60°C. The decompression will be done in ablation mode by rotating the device through 180° for 5 s in the posterior, medial and ventral third of the cervical disc. After failed conservative treatment over an average time period of 3 months we treated 26 patients with a contained herniated prolapse or protrusion with radicular arm pain by percutaneous decompression under utilization of the Coblation® technique with a controlled energy plasma-mediated field. A randomized control group of 30 patients was treated alone conservatively with medical and physical therapy in the same period. Results: The average preoperative VAS was 8.8. With a follow-up time of 2-years we found an average pain reduction with the visual pain score (VAS) of 2.3 who had a further check-up. The VAS was checked 24 h, 1 week, 3, 6, 12 and 24 months postoperatively. No complications with this method were seen. Comparable to the surgically treated group the conservative patients have had a VAS of 8.4. Under using conservative treatment with physical therapy, physiotherapy, analgetics and perineural injections we have had a diminution of the VAS to 5.1 after 2 years. Conclusion: The percutaneous decompression of the cervical disc protrusion with the Perc DC® - Spine Wand by using the Coblation mode is a quick and safe procedure. Furthermore, one may state a persistent pain relief in the follow-up time up to 2 years after the percutaneous decompression of the disc. © pringer-Verlag 2009.

Primary study

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Comparison of effectiveness according to different approaches of epidural steroid injection in lumbosacral herniated disk and spinal stenosis.

Authors Lee JH , Moon J , Lee SH
Journal Journal of back and musculoskeletal rehabilitation
Year 2009
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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PURPOSE: This study was to compare the effectiveness of the translaminar, caudal, and transforaminal technique with small and large volume of injectate in the treatment of lumbosacral herniation of intervetebral disc (HIVD) or spinal stenosis (SS). METHOD: Medical records reviewed retrospectively were of patients with radicular pain over 3 months and had diagnosed as HIVD or SS. Patients who underwent four weeks of treatments such as analgesics, anti-inflammatory drugs, or physical therapy for radicular pain with no improvement and afterwards received ESI were selected. Exclusion criteria was those who had suffered trauma, patients with other serious diseases, patients demonstrating adverse reactions to the medications, and patients with more than two levels of disease. The number of HIVD and SS group is 95 and 138, respectively. Visual Analog Scale (VAS) pain score, Patient Satisfaction Index (PSI), and Roland 5-point pain score were compared between different epidural approaches at pretreatment, 2 weeks, 1 month, and 2 months after treatment. RESULTS: Higher ratio of successful results was found in translaminar and transforaminal techniques than caudal technique in VAS in the HIVD group and in VAS and PSI in the SS group. Reduction of Roland score was maintained until 2 months in all techniques in HIVD and SS groups. In SS group, transforaminal groups showed more reduction of Roland score than caudal approach. No difference was found between small and large volume of transforaminal techniques. CONCLUSION: Translaminar and transforaminal approach were more effective than caudal approach in HIVD and SS groups. Especially, effectiveness of transforaminal approach was more prominent in SS group as compared with HIVD group.