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06/2007: Some Evidence to Support the Efficacy of Up-Right MRI of Recumbent MRI:
Eur J Radiol. 2007 Jun;62(3):444-8. Epub 2007 Apr 6. Evaluation of intervertebral disc herniation and hypermobile intersegmental instability in symptomatic adult patients undergoing recumbent and upright MRI of the cervical or lumbosacral spines. Ferreiro Perez A, Garcia Isidro M, Ayerbe E, Castedo J, Jinkins JR. Hospital De Madrid, Department of Radiology, Plaza Del Conde Del Valle De Suchil, 28015 Madrid, Spain. PURPOSE: The purpose of the study was to determine the difference in findings between recumbent and upright-sitting MRI of the cervical and lumbosacral spine in patients with related sign and symptoms. MATERIALS AND METHODS: A total of 89 patients were studied (lumbosacral spine: 45 patients; cervical: 44 patients). T1-weighted (TR: 350, TE: 20) fast spin echo and T2-weighted (TR: 2500, TE: 160) fast spin echo images were acquired in the sagittal and axial planes in both the recumbent and sitting-neutral positions. The images were acquired on the Uprighttrade mark MRI unit (Fonar Corporation, Melville, NY). Differences were sought between the recumbent and upright-sitting positions at all levels imaged, in both planes. RESULTS: The total number of cases of pathology was 68, including instances of posterior disc herniation and anterior and posterior spondylolisthesis. Focal posterior disc herniations were noted in 55 patients (cervical: 31, lumbosacral: 24) [62% of patients]. Six of these herniations (cervical: 4, lumbosacral: 2) [11%] were seen only on the upright-sitting study. Focal posterior disc herniations were seen to comparatively enlarge in size in 35 patients on the upright-seated examination (cervical: 21, lumbosacral: 14) [72%], and reduce in size in 9 patients (cervical: 5, lumbosacral: 4) [18%]. Degenerative anterior (n: 11) and posterior (n: 2) spondylolisthesis was seen in 13 patients (cervical: 0, lumbosacral: 13) [15% of patient total]. Anterior spondylolisthesis was only seen on the upright-seated examination in 4 patients (cervical: 0, lumbosacral: 4) [31%]. Anterior spondylolisthesis was comparatively greater in degree on the upright-seated study in 7 patients (cervical: 0, lumbosacral: 7) [54%]. Posterior spondylolisthesis was comparatively greater in degree on the recumbent examination in 2 patients (cervical: 0, lumbosacral: 2) [15%]. The overall combined recumbent miss rate in cases of pathology was 15% (10/68). The overall combined recumbent underestimation rate in cases of pathology was 62% (42/68). The overall combined upright-seated underestimation in cases of pathology was 16% (11/69). CONCLUSIONS: Overall, upright-seated MRI was found to be superior to recumbent MRI of the spine in 52 patents (recumbent missed pathology [n: 10]+recumbent underestimated pathology [n: 42]=52/89 total patients: 58%) in cases of posterior disc herniation and anterior spondylolisthesis. This seems to validate the importance of weight-bearing imaging in the spine that might be expected to unmask positional enlarging disc herniations and worsening spondylolisthesis. Overall, recumbent MRI was found to be superior to upright-seated MRI in 11 cases (11/89: 12%). The latter finding was possibly due to the fact that upright seated position is actually partial flexion that might be expected to reduce some cases of hypermobile posterior spondylolisthesis.
04/2007: Chemonucleolysis demonstrates effectiveness for the treatment of disc herniation: to bad the lawyers ruined it for use in this country: [here]
Clinics. 2007 Apr;62(2):175-80. Chemonucleolysis in lumbar disc herniation: a meta-analysis. Couto JM, Castilho EA, Menezes PR. Department of Preventive Medicine, Medical School, SÃ£o Paulo University, SÃ£o Paulo, SP, Brazil. PURPOSE: To carry out a systematic review and meta-analysis of the efficacy of chemonucleolysis in the treatment of lumbar disc herniation. METHODS: Clinical trials were selected from 3 electronic databases (The Cochrane Controlled Trials Register, MEDLINE, and EMBASE). Data were analyzed with the software STATA, using the meta command. RESULTS: Twenty-two clinical trials were eligible. For chemonucleolysis versus placebo, the summary risk ratio estimate for pain relief as outcome was 1.51 (95% CI: 1.27-1.80). The summary estimate was 1.07 (95% CI: 0.95-1.20) for the comparison between chymopapain and collagenase. Regarding chemonucleolysis with chymopapain versus surgery, the fixed-effect summary estimate of effect for pain relief was 0.93 (95% CI: 0.88-0.98) with surgery as the reference group. In this case, heterogeneity was statistically significant. CONCLUSIONS: Chemonucleolysis with chymopapain was superior to placebo and was as effective as collagenase in the treatment of lumbar disc prolapse. Results for studies comparing chemonucleolysis with surgery were heterogeneous, making it difficult to interpret the summary measure of effect.
07/2007: The drug Etanercept Bites the Dust for Treatment of Sciatica and Back Pain in a Very Well set up Double-Blind, Placebo-Controlled Trial.
Now, Etanercept, another TNF-a inhibitor (a fusion protein) has been shot down by a grade "A" randomized placebo-controlled double blind trial. In 2007, John Hopkins School of Medicine's SP Cohen, et al published the results of their investigation into the off-lable use of Etanercept for the treatment of sciatica. Unfortunately, they discovered that this very expensive treatment is no better than that of a placebo (suger pill). They concluded, "A single low dose of intradiscal etanercept does not seem to be an effective treatment for chronic radicular or discogenic low back pain."
Anesthesiology. 2007 Jul;107(1):99-105. A Double-blind, Placebo-controlled, Dose-Response Pilot Study Evaluating Intradiscal Etanercept in Patients with Chronic Discogenic Low Back Pain or Lumbosacral Radiculopathy. Cohen SP, Wenzell D, Hurley RW, Kurihara C, Buckenmaier CC, Griffith S, Larkin TM, Dahl E, Morlando BJ. * COL S. Cohen, Associate Professor, Pain Management Division, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland; Anesthesia Service, Department of Surgery, Walter Reed Army Medical Center. â€ MAJ D. Wenzell, Department of Surgery, Madigan Army Medical Center, Tacoma, Washington (currently in Iraq). â€¡ Assistant Professor, Pain Management Division, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland. Â§ Anesthesia Service, Department of Surgery, Walter Reed Army Medical Center. âˆ¥ LTC C. Buckenmaier, ** LTC (ret) T. Larkin, Anesthesia Service, Department of Surgery, # MAJ S. Griffith, Director, Pain Clinic, â€ â€ LTC E. Dahl, Department of Othopedic Surgery, Walter Reed Army Medical Center. BACKGROUND:: In recent years, convincing evidence has emerged implicating tumor necrosis factor alpha as a causative factor in radiculopathy and discogenic back pain. But although preliminary open-label studies demonstrated promising results for the treatment of low back pain with tumor necrosis factor-alpha inhibitors, early optimism has been tainted by a controlled study showing no significant benefit in sciatica. To determine whether outcomes might be improved by a more direct route of administration, the authors evaluated escalating doses of intradiscal etanercept in 36 patients with chronic lumbosacral radiculopathy or discogenic low back pain. METHODS:: A double-blind, placebo-controlled pilot study was conducted whereby six patients received 0.1, 0.25, 0.5, 0.75, 1.0, or 1.5 mg etanercept intradiscally in each pain-generating disc. In each escalating dose group of six patients, one received placebo. A neurologic examination and postprocedure leukocyte counts were performed in all patients at 1-month follow-up visits. In patients who experienced significant improvement in pain scores and function, follow-up visits were conducted 3 and 6 months after the procedure. RESULTS:: At 1-month follow-up, no differences were found for pain scores or disability scores between or within groups for any dose range or subgroup of patients. Only eight patients remained in the study after 1 month and elected to forego further treatment. No complications were reported, and no differences were noted between preprocedure and postprocedure leukocyte counts. CONCLUSIONS:: Although no serious side effects were observed in this small study, a single low dose of intradiscal etanercept does not seem to be an effective treatment for chronic radicular or discogenic low back pain.
03/2006: To Dig, or Not to Dig, this is the question when it comes to discectomy: Higher patient satisfaction was obtained by the surgeon digging into the annular tear and cleaning it out of fragments; however, the reherniation rate was twice that of non-digging (my term) discectomy.
Spine. 2006 Mar 15;31(6):653-7. A prospective controlled study of limited versus subtotal posterior discectomy: short-term outcomes in patients with herniated lumbar intervertebral discs and large posterior anular defect. Carragee EJ, Spinnickie AO, Alamin TF, Paragioudakis S. Division of Orthopedic Surgery, Stanford University School of Medicine, Stanford, CA, USA. firstname.lastname@example.org STUDY DESIGN: Prospective observational study with historical control. The prospective study population consisted of 30 patients undergoing a posterior lumbar subtotal discectomy for lumbar disc herniation. This group was compared to a historical cohort of 46 patients treated with limited discectomy alone. OBJECTIVE: To compare clinical outcomes after limited versus subtotal discectomy for lumbar disc herniations. SUMMARY OF BACKGROUND DATA: Large posterior anular defects found at posterior discectomy have been associated with more frequent reherniation when treated with limited discectomy (i.e., removing only extruded or loose intervertebral fragments). A trial of more aggressive discectomy (subtotal) was undertaken to determine if the rate of reherniation could be decreased with this technique. METHODS: A total of 30 patients undergoing a posterior lumbar discectomy for lumbar disc herniation were treated with an aggressive (subtotal) resection of intervertebral disc material after removal of the extruded or protruded fragments. This group was compared against a historical cohort of 46 patients treated with limited discectomy alone. Reherniation rates and clinical outcomes were determined by independent evaluation at 6, 12, and 24 months after surgery. RESULTS: The reherniation rate in the limited discectomy group was 18% versus 9% in the subtotal discectomy group at follow-up (P = 0.1). However, the back pain (visual analog scale) (P = 0.02) and Oswestry scores (P = 0.06) were worse in the subtotal discectomy group at 12-month follow-up. Time to return to work was longer, and pain medication usage was higher in the subtotal discectomy group at 12-month follow-up. Despite a trend toward a higher reherniation rate, the patient satisfaction at 2-year follow-up was higher in the limited discectomy group. CONCLUSIONS: The more aggressive removal of remaining intervertebral disc material may decrease the risk of reherniation, but the overall outcome was less satisfactory, especially during the first year after surgery.
12/2006: MRI's do NOT demonstrate a new disc herniation or change despite serious new incident of back pain: Another strike against the diagnostic power of MRI: Only nerve root compression may be diagnostic.
Spine J. 2006 Nov-Dec;6(6):624-35. Epub 2006 Oct 11. Are first-time episodes of serious LBP associated with new MRI findings? Carragee E, Alamin T, Cheng I, Franklin T, van den Haak E, Hurwitz E. Department of Orthopaedic Surgery, Stanford University School of Medicine, 300 Pasteur Drive, Rm. R-171, Stanford, CA 94305, USA. email@example.com
BACKGROUND: Magnetic resonance (MR) imaging is frequently used to evaluate first-time episodes of serious low back pain (LBP). Common degenerative findings are often interpreted as recent developments and the probable anatomic cause of the new symptoms. To date no prospective study has established a baseline MR status of the lumbar spine in subjects without significant LBP problems and prospectively surveyed these subjects for acute changes shortly after new and serious LBP episodes. This method can identify new versus old MR findings possibly associated with the acute symptomatic episode. PURPOSE: To determine if new and serious episodes of LBP are associated with new and relevant findings on MRI. STUDY DESIGN: Prospective observational study with baseline and post-LBP MRI monitoring of 200 subjects over 5 years. OUTCOME MEASURES: Clinical outcomes: LBP intensity (visual analogue scale), Oswestry Disability Index, and work loss. MRI outcomes: disc degeneration, herniation, annular fissures, end plate changes, facet arthrosis, canal stenosis, spondylolisthesis, and root impingement. METHODS: 200 subjects with a lifetime history of no significant LBP problems, and a high risk for new LBP episodes were studied at baseline with physical examination, plain radiographs, and MR imaging. Subjects were followed every 6 months for 5 years with a detailed telephone interview. Subjects with a new severe LBP episode (LBP>or=6/10,>1 week) were assessed for new diagnostic tests. New MR imaging, taken within 6 to 12 weeks of the start of a new LBP episode, was compared with baseline (asymptomatic) images. Two independent and blinded readers evaluated each baseline and follow-up study. RESULTS: During the 5-year observation period of 200 subjects, 51 (25%) subjects were evaluated with a lumbar MRI for clinically serious LBP episodes, and 3/51 (6%) had a primary radicular complaint. These 51 subjects had 67 MR scans. Of 51 subjects, 43 (84%) had either unchanged MR or showed regression of baseline changes. The most common progressive findings were disc signal loss (10%), progressive facet arthrosis (10%), or increased end plate changes (4%). Only two subjects, both with primary radicular complaints, had new findings of probable clinical significance (4%). Subjects having another MR were more likely to have had chronic pain at baseline (odds ratio [OR]=3.19; 95% confidence interval [CI] 1.61-6.32), to smoke (OR=5.81; 95% CI 1.99-16.45), have baseline psychological distress (OR 2.27; 95% CI 1.15-4.49), and have previous disputed compensation claims (OR=2.35; 95% CI 0.97-5.69). Subjects involved in current compensation claims were also more likely to have an MR scan to evaluate the LBP episode (risk ratio=4.75, p<.001), but were unlikely to have significant new findings. New findings were not more frequent in subjects with LBP episodes developing after minor trauma than when LBP developed spontaneously. CONCLUSION: Findings on MR imaging within 12 weeks of serious LBP inception are highly unlikely to represent any new structural change. Most new changes (loss of disc signal, facet arthrosis, and end plate signal changes) represent progressive age changes not associated with acute events. Primary radicular syndromes [however] may have new root compression findings associated with root irritation.
12/2006: Treatment success for Discogenic Pain syndrome is Poor: Nice Editorial by Dr. Eugene Carragee, MD, Head of Stanford's Orthopedic Surgery Department. [click here for full article] JAMA. 2006;296:2485-2487. Or visits JAMA's webs site (here) for the article.
Surgical treatment for primary back pain associated with disk changes ("discogenic pain") is the more controversial and less successful. When examination of the lumbar spine reveals only common degenerative changes, the relationship of these findings to a patient's back pain is unclear. Disk degeneration, anular fissures, small protrusions, and facet arthritis are commonly found in individuals with little or no back pain. Furthermore, many studies have shown that serious disability in this group is associated with abnormal psychological profiles, multiple chronic pain processes, and compensation issues. Conversely, longitudinal studies have found that the severity of chronic pain illness in this group appears to correlate much less well with presence or extent of degenerative findings than with these psychosocial or generalized neurophysiological comorbid conditions. Not surprisingly, the surgical treatment of this poorly defined discogenic pain illness has been somewhat disappointing. Randomized trials of lumbar fusion compared with various nonsurgical strategies have shown neither consistently good outcomes with surgery nor clear benefit over nonsurgical treatments. In the randomized controlled trial (RCT) with the best surgical results, the improvement in pain intensity score was only 2 points (on a 10-point scale), and the disability improvement by Oswestry Disability Index was only 10 to 12 points (on a 100-point scale). Furthermore, clinical outcomes appear to steadily deteriorate after 6 months. In a large population-based study, approximately 18% of patients who had spinal fusion for degenerative conditions experienced procedure-related complications; 20% of these patients went on to reoperation over the next 5 years.
01/2007: Nucleoplasty Investigation Touts a 88% success rate for treatment of contained small to moderate sized disc herniations: Really? I don't think so. Although I haven't got the entire article as of yet, I took issue with the claim that nucleoplasty treatment resulted in a 88% success rate at one year. Contradictingly, in the abstract (see below) the average Oswestry score at one year post-nucleoplasty was 20! Twenty is still moderately disabled (that's about my score) and certainly is not normal. Why in the world the creators of nucleoplasty haven't tested this technique via double-blind randomized controlled trial (the gold standard) is beyond me--maybe they are scared that the results will show nucleoplasty is no better than discectomy or even non-surgical conservative care or even placebo!
Spine J. 2007 Jan-Feb;7(1):88-92; discussion 92-3. Epub 2006 Nov 20. The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients. Mirzai H, Tekin I, Yaman O, Bursali A. Department of Neurosurgery, Celal Bayar University, School of Medicine, Manisa, Turkey. firstname.lastname@example.org BACKGROUND CONTEXT: Nucleoplasty is a minimally invasive, percutaneous procedure that uses radiofrequency energy to ablate nuclear material and create small channels within the disc. PURPOSE: To evaluate the efficacy of nucleoplasty technique in patients with leg pain caused by radicular encroachment. STUDY DESIGN/SETTING: A prospective clinical study of subjects with lumbar disc herniation, and radicular pain resistant to previous medical treatment and physiotherapy for a period of at least 3 months. PATIENT SAMPLE: Fifty-two consecutive patients with leg pain and magnetic resonance imaging evidence of small and medium-sized herniated discs correlating with the patient's symptoms (contained disc herniation<6 mm, with a disc height>/=50% in comparison to normal adjacent discs) were included. OUTCOME MEASURES: Visual analogue scale (VAS) was administered and Oswestry disability questionnaires were filled out at preprocedure and postprocedure 2 weeks, 6 months, and 1 year. Reduction of analgesic treatment and the patients' satisfaction were also recorded. METHODS: All procedures were performed under local anesthesia and fluoroscopic guidance on an outpatient basis. Patients underwent discography to evaluate annular integrity just before nucleoplasty. Channels were created in the nucleus by advancing the radiofrequency probe (ablating) and withdrawing it (coagulation). In all patients six channels were created. RESULTS: Thirty-four patients had one and 18 had two discs treated; a total of 70 procedures were performed. Mean age of patients was 44.8+/-8.6 years. The mean follow-up period was 12.1+/-1.6 months. Mean VAS reduced from preprocedure 7.5 to 3.1 at postprocedure 6 months and to 2.1 at the latest follow-up. Mean Oswestry index decreased from 42.2 to 24.8 at 6 months and to 20.5 at the latest examination. Analgesic consumption was stopped or reduced in 42 patients (85%) at 6 months and in 46 patients (94%) 1 year after the procedure. Overall patient satisfaction was 81% at 2 weeks, 85% at 6 months, and 88% at the latest follow-up. There were no complications related to the procedures. CONCLUSIONS: Our results encourage us to use nucleoplasty in carefully selected patients with leg pain caused by radicular encroachment. We recommend applying this minimally invasive technique only in those patients with small (<6 mm) contained disc herniations, with a disc height of>or=50% and with annular integrity.
01/2007: Some new evidence for the theory that sciatica may be caused by an autoimmune attack.
This Spine published investigation lends support to my personal favorite theory that autoimmune attack is the culpret in sciatica. In this study, nucleus pulposus was extrated from live pigs and then inplanted in the pigs own subcutaneous tissue in special chambers (there was a control chamber without nucleus pulposus). After killing the pigs, the chambers with nucleus pulposus were attached by the immune system and the emply chambers were not. This indicates that the immune system--at least in pigs, which have a similar disc to ours--does attached nucleus pulposus. Here's the study:
Spine. 2007 Jan 15;32(2):168-73. Autoimmune properties of nucleus pulposus: an experimental study in pigs. Geiss A, Larsson K, Rydevik B, Takahashi I, Olmarker K. Department of Orthopaedics, Sahlgrenska University Hospital, GÃ¶teborg University, GÃ¶teborg, Sweden. STUDY DESIGN: Assessment of activated T and B cells in a subcutaneous chamber filled with autologous nucleus pulposus using flow cytometry and immunohistochemistry. OBJECTIVES: To examine if subcutaneously placed autologous nucleus pulposus may attract activated T and B cells in an animal model. SUMMARY OF BACKGROUND DATA: Nucleus pulposus has been suggested to trigger an autoimmune response if exposed to the immune system, for example, in association with disc herniation. T-cell activation represents a hallmark in the generation of an autoimmune response, subsequently leading to the differentiation of B cells, but a causal association between the exposure of nucleus pulposus to the systemic circulation and T and B cell activation is still lacking. METHODS: Autologous nucleus pulposus was harvested from the intervertebral disc of 9 pigs and placed subcutaneously in perforated titanium chambers. In order to control for the effect of the titanium chamber, an additional empty chamber was placed subcutaneously in each pig. After 7 days, the pigs were killed and the chambers were harvested. Flow cytometry and immunohistochemistry were used for analysis of T-helper cells (CD4+), cytotoxic T cells (CD8+), and B cells (Igkappa) in the chamber exudates and T cells (CD45RC) in the remaining blood clot tissue of the chamber. RESULTS: As compared with the empty chambers, the proportion of activated T cells (CD4+ and CD8+) was significantly higher in the exudate of the nucleus pulposus filled chamber. The proportion of activated B cells expressing immunoglobulin kappa (Igkappa) was also significantly elevated in the exudate of the nucleus pulposus chambers. The analysis of the remaining chamber tissue revealed a significantly higher amount of T cells (CD45RC) in the nucleus pulposus chambers than in the empty chambers. CONCLUSIONS: The present findings indicate that nucleus pulposus attracts activated T and B cells. However, since the cell population in the nucleus pulposus of young pigs may differ from that of adult humans, the obtained data may not be directly transferred to the human situation of a disc herniation. The observations in the present study may nevertheless explain some of the local tissue reactions occurring in association with disc herniation and nerve root involvement, thereby providing further insight into the pathophysiology of sciatica.
05/2007: Surgery for disc herniation induced sciatica a quicker fix, but at one year, there's not much difference as if no surgery was performed.
Here's another confirmation of the Volvo Award Winning study of Weber and the more recent MAINE study: discectomy will relieve disc herniation induced sciatica faster; however, at one year, patient's that did not have the surgery were just as good as the ones that had surgery. Here's the study that was published in the Number on medical research journal: the New England Journal of Medicine:
Peul WC, et al. "Surgery versus prolonged conservative treatment for sciatica." N Engl J Med. 2007 356(22):2239-43.
N. Engl. J. Med. 2007 May 31;356(22):2245-56. Comment in: N Engl J Med. 2007 May 31;356(22):2239-43. Surgery versus prolonged conservative treatment for sciatica. Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW; Leiden-The Hague Spine Intervention Prognostic Study Group . Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands. email@example.com BACKGROUND: Lumbar-disk surgery often is performed in patients who have sciatica that does not resolve within 6 weeks, but the optimal timing of surgery is not known. METHODS: We randomly assigned 283 patients who had had severe sciatica for 6 to 12 weeks to early surgery or to prolonged conservative treatment with surgery if needed. The primary outcomes were the score on the Roland Disability Questionnaire, the score on the visual-analogue scale for leg pain, and the patient's report of perceived recovery during the first year after randomization. Repeated-measures analysis according to the intention-to-treat principle was used to estimate the outcome curves for both groups. RESULTS: Of 141 patients assigned to undergo early surgery, 125 (89%) underwent microdiskectomy after a mean of 2.2 weeks. Of 142 patients designated for conservative treatment, 55 (39%) were treated surgically after a mean of 18.7 weeks. There was no significant overall difference in disability scores during the first year (P=0.13). Relief of leg pain was faster for patients assigned to early surgery (P<0.001). Patients assigned to early surgery also reported a faster rate of perceived recovery (hazard ratio, 1.97; 95% confidence interval, 1.72 to 2.22; P<0.001). In both groups, however, the probability of perceived recovery after 1 year of follow-up was 95%. CONCLUSIONS: The 1-year outcomes were similar for patients assigned to early surgery and those assigned to conservative treatment with eventual surgery if needed, but the rates of pain relief and of perceived recovery were faster for those assigned to early surgery.
11/2006: New Investigation published in Spine that compares traditional endoscopic discectomy to endoscopic discectomy with add Chymopapain.
Although I'm still not a big fan of endoscopic discectomy, and won't be until they compare it to traditional microscopic discectomy in a randomized double blind controlled trial (which they should have a long time ago, I like the idea of the added Chymopapain to the procedure; Chymopapain was probably this countries best non-invasive treatment for contained disc herniation until the lawyers attacked it a la silicon breast implant. Anyway, this German study touts an unbelievable success rate (probably via "cherry picking") that must be taken with a grain of salt; however, it's still a very interesting study that seems to support endoscopic discectomy with Chymopapain as an effective treatment intervention for disc herniation. NOW LET'S GET THAT RANDOMIZED CONTROLLED TRIAL DONE! [My beef with endoscopic discectomy is that it creates a new annular tear in an already damaged disc than then digs out a "work space" in the center to accommodate the endoscopic tools. If one were to believe the animal research, creating holes in the disc is dooming it to further degeneration and annular tearing somewhere [5 - 7 years] down the road.]
Spine. 2006 Nov 15;31(24):E890-7. Transforaminal posterolateral endoscopic discectomy with or without the combination of a low-dose chymopapain: a prospective randomized study in 280 consecutive cases. Hoogland T, Schubert M, Miklitz B, Ramirez A. Department of Spine Surgery, Alpha Klinik Munich, Munich, Germany. firstname.lastname@example.org
STUDY DESIGN: A prospective randomized study involving 280 consecutive cases of lumbar disc herniation managed either by an endoscopic discectomy alone or an endoscopic discectomy combined with an intradiscal injection of a low dose (1000 U) of chymopapain. OBJECTIVE: To compare outcome, complications, and reherniations of both techniques. SUMMARY OF BACKGROUND DATA: Despite a low complication rate, posterolateral endoscopic nucleotomy has made a lengthy evolution because of an assumed limited indication. Chemonucleolysis, however, proven to be safe and effective, has not continued to be accepted by the majority in the spinal community as microdiscectomy is considered to be more reliable. METHOD: A total of 280 consecutive patients with a primary herniated, including sequestrated, lumbar disc with predominant leg pain, was randomized. A clinical follow-up was performed at 3 months, and at 1 and 2 years after the index operation with an extensive questionnaire, including the visual analog scale for pain and the MacNab criteria. The cohort integrity at 3 months was 100%, at 1 year 96%, and at 2 years 92%. RESULTS: At the 3-month evaluation, only minor complications were registered. At 1-year postoperatively, group 1 (endoscopy alone) had a recurrence rate of 6.9% compared to group 2 (the combination therapy), with a recurrence rate of 1.6%, which was a statistically significant difference in favor of the combination therapy (P = 0045). At the 2-year follow-up, group 1 reported that 85.4% had an excellent or good result, 6.9% a fair result, and 7.7% were not satisfied. At the 2-year follow-up, group 2 reported that 93.3% had an excellent or good result, 2.5% a fair result, and 4.2% were not satisfied. This outcome was statistically significant in favor of the group including chymopapain. There were no infections or patients with any form of permanent iatrogenic nerve damage, and no patients had a major complication. CONCLUSIONS: A high percentage of patient satisfaction could be obtained with a posterior lateral endoscopic discectomy for lumbar disc herniation, and a statistically significant improvement of the results was obtained when an intradiscal injection of 1000 U of chymopapain was added. There was a low recurrence rate with no major complications. The method can be applied in any type of lumbar disc herniation, including the L5-S1 level.
12-30-06: Degerative Disc Disease decrease blood flow (and nutrient flow) to the disc. ISSLS Prize Winner 2004.
Spine. 2004 Dec 1;29(23):2654-67. ISSLS prize winner: A study of diffusion in human lumbar discs: a serial magnetic resonance imaging study documenting the influence of the endplate on diffusion in normal and degenerate discs. Rajasekaran S, Babu JN, Arun R, Armstrong BR, Shetty AP, Murugan S. Department of Orthopaedics and Spine Surgery, Ganga Hospital, Coimbatore, India. email@example.com
STUDY DESIGN: An in vivo serial magnetic resonance imaging study of diffusion characteristics in human lumbar discs over 24 hours in healthy volunteers and patients with low back pain. OBJECTIVES: To document the temporal pattern of diffusion in normal human lumbar discs and to study the influence of the vascularity of bone and the status of endplate on diffusion in the normal and degenerate discs. SUMMARY OF BACKGROUND DATA: Diffusion is the only source of nutrition to the discs, but no firm data are available on pattern of diffusion in humans. More data on this important subject are required to improve our understanding of disc degeneration and to probe research possibilities for preventing the same. METHODS: The diffusion pattern over 24 hours following gadodiamide injection was studied in 150 discs (96 normal and 54 degenerate). Signal intensity values for three regions of interest in bone (i.e., vertebral body, subchondral bone, and endplate zone) and seven in the disc were calculated, and normal percentiles of diffusion were derived for these regions. Enhancement percentage for each time period, peak enhancement percentage for each region, and the time taken to achieve peak enhancement percentage (Tmax) were used to define and compare diffusion characteristics and plot a time-intensity curve to document the 24-hour temporal pattern. The correlation of blood flow of the bone as measured by peak enhancement percentage of vertebral body, the status of the endplate zone as measured by the peak enhancement percentage, and Tmax of the endplate zone were correlated with the diffusion of the disc.Univariate analysis of variance, multiple comparisons, appropriate tests for significance, and stepwise linear regression analysis were used for analysis of the data using SPSS software. RESULTS: In normal discs, a "diffusion march" from the vertebral body to the center of disc was noted with the SImax being observed at 5 min in the vertebral body and subchondral bone, at 2 hours in the endplate zone, and at 6 hours in the nucleus pulposus. A significant difference in mean peak enhancement percentage was observed between that of the body and the discs in those less than 10 years and those above the age of 20 years (P < 0.001). Alterations in endplate zone produced distinct magnetic resonance imaging signs of disturbance in diffusion, which offered a reliable noninvasive method of identifying endplate cartilage damage. Stepwise linear regression analysis showed that the significant variable influencing diffusion to the center of the nucleus pulposus of the total sample was peak enhancement percentage of endplate zone (R2 = 0.216; P < 0.001), that of degenerate discs was peak enhancement percentage of endplate zone (R2 = 0.322; P < 0.001), and that of normal discs (R2 = 0.324; P < 0.001) was age. CONCLUSIONS: Serial postcontrast magnetic resonance imaging studies offer a reliable method of assessing the diffusion of the discs and the functional status of the endplate cartilage. Endplate cartilage damage increases with age and produces considerable changes in diffusion. The present study has described reliable signs by which these damages can be identified in vivo. Aging and degeneration have been shown to be two separate processes by documenting clear-cut differences in diffusion. The present data encourage use of diffusion studies as a noninvasive method to assess the physiologic status of the disc and endplate and to study the effect of drugs, smoking, mechanical loading, exercises, etc. on the physiology of the disc.
12-30-06: Fusion treatment demonstated as efficacious for chronic pain as the result of spondylolisthesis in a well done randomized controlled trial that compared fusion to exercise.
1: Spine J. 2005 Jan-Feb;5(1):36-44. The long-term effect of posterolateral fusion in adult isthmic spondylolisthesis: a randomized controlled study. Ekman P, Moller H, Hedlund R. Stockholm Soder Hospital, Department of Orthopedic Surgery, Stockholm Soder Hospital, 118 83 Stockholm, Sweden. firstname.lastname@example.org
BACKGROUND: Today there is some evidence-based medicine support for a positive short-term treatment effect of fusion in chronic low back pain in spondylolisthesis and in nonspecific degenerative lumbar spine disorders. The long-term effect is, however, unknown. PURPOSE: To determine the long-term outcome of lumbar fusion in adult isthmic spondylolisthesis. STUDY DESIGN: Prospective, randomized controlled study comparing a 1-year exercise program with instrumented and non-instrumented posterolateral fusion with average long-term follow-up of 9 years (range, 5-13). PATIENT SAMPLE: 111 patients aged 18 to 55 years with adult lumbar isthmic spondylolisthesis at L5 or L4 level of all degrees, and at least 1-year's duration of severe lumbar pain with or without sciatica. OUTCOME MEASURES: Pain and functional disability was quantified by pain (VAS), the Disability Rating Index (DRI), the Oswestry Disability Index (ODI) work status, and global assessment of outcome by the patient into much better, better, unchanged or worse. Quality of life was assessed by the SF-36. METHODS: The patients were randomly allocated to treatment with 1) a 1-year exercise program (n=34), 2) posterolateral fusion without pedicle screw instrumentation (n=37), or 3) posterolateral fusion with pedicle screw instrumentation (n=40). Long-term follow-up was obtained in 101 (91%) patients. Nine patients in the exercise group were eventually operated on. RESULTS: Longitudinal analysis: At long-term follow-up pain and functional disability were significantly better than before treatment in both surgical groups. No significant differences were observed between instrumented and non-instrumented patients in any variable studied. In the exercise group the pain was significantly reduced but not the functional disability. Compared with the 2-year follow-up a significant increase in functional disability was observed, as measured by the DRI, but not the ODI, in the surgical group at long term. In the exercise group no significant changes were observed between the 2-year and the long-term follow-up. Cross-sectional analysis: Between the surgical and conservative group no significant differences were observed in any outcome measurement at long-term follow-up except for global assessment, which was significantly better for surgical patients. Of surgical patients 76% classified the overall outcome as much better or better compared with 50% of conservatively treated patients (p=0.015). Quality of life as estimated by the SF-36 at long term was not different between treatment groups in any of the eight domains studied but was considerably lower than for the normal population. CONCLUSIONS: Posterolateral fusion in adult lumbar isthmic spondylolisthesis results ina modestly improved long-term outcome compared with a 1-year exercise program. Although the results show that some of the previously reported short-term improvement is lost at long term, patients with fusion still classify their global outcome as clearly better than conservatively treated patients. Furthermore, because the long-term outcome of the patients conservatively treated most likely reflects the natural course, one can also conclude that no considerable spontaneous improvement should be expected over time in adult patients with symptomatic isthmic spondylolisthesis. Substantial pain, functional disability and a reduced quality of life will in most patients most likely remain unaltered over many years.
12-26-06: Spinal Decompression Systems: WHERE'S THE PROOF! Stanford investigates Spinal Decompression and finds no quality supportive research. We seem to be getting bombarded with ads that tout certain spinal decompression systems are the "cure" for chronic back pain. They're making millions yet have failed to proof their product works.... WHY?
1: Pain Pract. 2006 Sep;6(3):171-8.
Systematic literature review of spinal decompression via motorized traction for
chronic discogenic low back pain.
Macario A, Pergolizzi JV.
Department of Anesthesia, Stanford University School of Medicine, Stanford,
California 94305-5640, USA. [email]email@example.com[/email]
OBJECTIVE: The objective of this study was to systematically review the literature to assess the efficacy of nonsurgical spinal decompression achieved with motorized traction for chronic discogenic lumbosacral back pain. DESIGN: Computer-aided systematic literature search of MEDLINE and the Cochrane
collaboration for prospective clinical trials on adults with low back pain in the English literature from 1975 to October 2005. Methodologic quality for each study was assessed. Studies were included if the intervention group received motorized spinal decompression and the comparison group received sham or another
type of nonsurgical treatment. RESULTS: Data from 10 studies were fully analyzed. Seven studies were randomized controlled trials using various apparatus types. Because of this low number, we also analyzed three nonrandomized case series studies of spinal decompression systems. As the overall quality of studies was low and the patient groups heterogeneous, a meta-analysis was not appropriate and a qualitative review was undertaken. Sample sizes averaged 121 patients (range 27-292), with six of the seven randomized studies reporting no difference with motorized spinal decompression and one study reporting reduced pain but not disability. The three unrandomized studies (no control group) of motorized spinal decompression found a 77% to 86% reduction in pain. CONCLUSIONS: These data suggest that the efficacy of spinal decompression achieved with motorized traction for chronic discogenic low back pain remains unproved. This may be, in part, due to heterogeneous patient groups and the difficulties involved in properly blinding patients to the mechanical pulling mechanism. Scientifically more rigorous studies with better randomization, control groups, and standardized outcome measures are needed to overcome the limitations of past studies.
12-26-06: X-Stop for Stenosis: Two decent investigations from St. Mary's that demonstrates efficacy. I've yet to find a negative investigation into X-Stop's efficacy as a treatment intervention for stenosis.
1: Spine. 2005 Jun 15;30(12):1351-8.
A multicenter, prospective, randomized trial evaluating the X STOP interspinous
process decompression system for the treatment of neurogenic intermittent
claudication: two-year follow-up results.
Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson
DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM.
St Mary's Hospital, San Francisco, California, USA. firstname.lastname@example.org
STUDY DESIGN: A randomized, controlled, prospective multicenter trial comparing the outcomes of neurogenic intermittent claudication (NIC) patients treated with the interspinous process decompression system (X STOP) with patients treated nonoperatively. OBJECTIVE: To determine the safety and efficacy of the X STOP interspinous implant. SUMMARY OF BACKGROUND DATA: Patients suffering from NIC
secondary to lumbar spinal stenosis have been limited to a choice between nonoperative therapies and decompressive surgical procedures, with or without fusion. The X STOP was developed to provide an alternative therapeutic treatment. METHODS.: 191 patients were treated, 100 in the X STOP group and 91
in the control group. The primary outcomes measure was the Zurich Claudication Questionnaire, a patient-completed, validated instrument for NIC. RESULTS: At every follow-up visit, X STOP patients had significantly better outcomes in each domain of the Zurich Claudication Questionnaire. At 2 years, the X STOP patients improved by 45.4% over the mean baseline Symptom Severity score compared with
7.4% in the control group; the mean improvement in the Physical Function domain was 44.3% in the X STOP group and -0.4% in the control group. In the X STOP group, 73.1% patients were satisfied with their treatment compared with 35.9% of control patients. CONCLUSIONS: The X STOP provides a conservative yet effective treatment for patients suffering from lumbar spinal stenosis. In the continuum of treatment options, the X STOP offers an attractive alternative to both conservative care and decompressive surgery.
1: J Neurosurg Spine. 2006 Dec;5(6):500-7.
Quality of life of lumbar stenosis-treated patients in whom the X STOP
interspinous device was implanted.
Hsu KY, Zucherman JF, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson
DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Cauthen JC, Ozuna RM.
Department of Orthopaedics, St. Mary's Medical Center, St. Mary's Spine Center,
San Francisco, California 94117, USA. email@example.com
OBJECT: This study was conducted to compare the quality of life (QOL) in patients with neurogenic intermittent claudication (NIC) secondary to lumbar spinal stenosis (LSS). Using the 36-Item Short Form (SF-36) questionnaire, the authors compared the results obtained in patients treated with the X STOP
Interspinous Process Decompression (IPD) System with those obtained in patients who underwent nonoperative therapies. METHODS: Patients with LSS were enrolled in a prospective 2-year multicenter study and randomized either to the X STOP or nonoperative group. The SF-36 survey was used to assess the QOL before treatment and at 6 weeks, 6 months, 1 year, and 2 years posttreatment. An analysis of
variance was used to compare individual pre- and posttreatment mean SF-36 domain scores between the two groups and within each treatment group. At all posttreatment time points, the authors observed the following: (1) mean domain scores in X STOP-treated patients were significantly greater than those in
patients treated nonoperatively, with the exception of the mean General Health (GH), Role Emotional, and Mental Component Summary scores at 2 years; and (2) mean posttreatment domain scores documented in X STOP-treated patients were significantly greater than mean pretreatment scores, with the exception of mean GH scores at 6, 12, and 24 months. CONCLUSIONS: The results of this study demonstrate that the X STOP device is significantly more effective than nonoperative therapy in improving the QOL in patients with LSS. The results are comparable with those reported in other studies involving traditionaldecompressive techniques for LSS and suggest that the X STOP implant can provide an effective treatment compared with nonoperative and conventional surgical therapies.
11-24-06: Volvo award winner, Jaro Karppinen, publishes a rare double-blind investigation into the efficacy of discectomy as an intervention for disc herniation-induced sciatica, and the results mirror that of the famos, Volvo Award Winning, investigation by Weber in 1982: in the long-term, discectomy is no more effective than conservative care for disc herniation-induced sciatica/back pain.
Osterman H, Seitsalo S, Karppinen J, Malmivaara A. "Effectiveness of microdiscectomy for lumbar disc herniation: a randomized controlled trial with 2 years of follow-up." Spine. 2006 Oct 1;31(21):2409-14.
Orton Orthopaedic Hospital of the Invalid Foundation, Helsinki, Finland.
STUDY DESIGN: Prospective randomized controlled trial. OBJECTIVE: To assess effectiveness of microdiscectomy in lumbar disc herniation patients with 6 to 12 weeks of symptoms but no absolute indication for surgery.
SUMMARY OF BACKGROUND DATA: There is limited evidence in favor of discectomy for prolonged symptoms of lumbar disc herniation. However, only one randomized trial has directly compared discectomy with conservative treatment.
METHODS:Fifty-six patients (age range, 20-50 years) with a lumbar disc herniation, clinical findings of nerve root compression, and radicular pain lasting 6 to 12 weeks were randomized to microdiscectomy or conservative management. Fifty patients (89%) were available at the 2-year follow-up. Leg pain intensity was the primary outcome measure.
RESULTS: There were no clinically significant differences between the groups in leg or back pain intensity, subjective disability, or health-related quality of life over the 2-year follow-up, although discectomy seemed to be associated with a more rapid initial recovery. In a subgroup analysis, discectomy was superior to conservative treatment when the herniation was at L4-L5.
CONCLUSIONS: Lumbar microdiscectomy offered only modest short-term benefits in patients with sciatica due to disc extrusion or sequester. Spinal level of the herniation may be an important factor modifying effectiveness of surgery, but this hypothesis needs verification.
11-24-06: Although this is old news, it's nice to see an investigation looking into it. For what it's worth, there are old investigations that have demonstrated annular tears are NOT always on the side of the radiculopathy.
Peng B, Wu W, et al. "Chemical radiculitis." Pain. 2006 Sep 7; [Epub ahead of print]
The theory of chemical radiculitis had been put forward about 30 years ago, but as yet it has not been proved by clinical studies. The aim of the current studies was to determine whether the annular tear of a painful disc proved by discography is the cause of radiating leg pain (radiculopathy) in patients with discogenic low back pain. Forty-two patients with discogenic low back pain at single disc level with concomitant radiating leg pain were studied in order to analyse the relationship between site of annular tear and side of radiating leg pain. Electromyogram and motor nerve conduction velocity were monitored to examine nerve root injury. The current studies found that there was a significant positive correlation between the site of annular tear and the side of radiation pain. Abnormalities of electromyogram and reduction of motor nerve conduction velocity were found on the side of radiating leg pain.
Conclusion: The studies indicated that leakage of chemical mediators or inflammatory cytokines, which are produced in the painful disc, into epidural space through annular tear could lead to injury to adjacent nerve roots, and it might constitute the primary pathophysiologic mechanism of radiating leg pain in patients with discogenic low back pain but with no disc herniation.
11-24-06: Discography fails to predict a disc as the cause of low back pain.
Stanford's Volvo Award Winning Eugene Carragee is at it again; this time the target is provocative disography's (a favorite of his) efficacy and fusion:
Although this was a small investigation (only 30+ patients), it's certainly another "strike" against the use of provocation discography as a diagnostic tool in regard to discogenic pain.
Spine. 2006 Aug 15;31(18):2115-23. "A gold standard evaluation of the "discogenic pain" diagnosis as determined by provocative discography."
Carragee EJ, Lincoln T, Parmar VS, Alamin T. -- Orthopaedic Surgery Division, Stanford School of Medicine, Stanford, CA 94305, USA. [email]firstname.lastname@example.org[/email]
STUDY DESIGN: This is a prospective study of the validity of a positive test result in provocative lumbar discography for the diagnosis of "discogenic pain."
OBJECTIVE: To investigate the hypothesis that provocative discography by strict criteria accurately identifies a low back pain illness due to a primary disc lesion.
SUMMARY AND BACKGROUND DATA: According to the Sackett and Haynes criteria for establishing diagnostic test validity, no test without a gold standard external standard can be meaningfully applied. Provocative discography as a test for determining "discogenic pain" has, to date, not been compared against a gold standard. Absent a gold standard reference, there can be no validity assessment or systematic improvement of test accuracy. This is the first study to apply an external gold standard evaluation of the diagnostic validity of discography in any manner.
METHODS: Over a 5-year period using a strict enrollment protocol, 32 patients with low back pain and a positive single-level low-pressure provocative discogram, underwent spinal fusion. Subjects with known patient selection comorbidities were excluded. Generic surgical limitations/morbidity were controlled by comparison to the clinical outcomes of a strictly-matched cohort of 34 patients having a well-accepted single-level lumbar pathology (unstable spondylolisthesis). Treatment success was compared between groups.
RESULTS: In the control-spondylolisthesis group, 23 of 32 patients (72%) met the highly effective success criteria compared with 8 of 30 in the presumed discogenic pain cohort (27%). The proportion of patients who met the "minimal acceptable outcome" was 29 of 32 (91%) in the spondylolisthesis group and 13 of 30 (43%) in the presumed discogenic pain group. Adjusting for surgical morbidity and dropout failure, by either criteria of success, the best-case positive predictive value of discography was calculated to be 50% to 60%.
CONCLUSIONS: Positive discography was not highly predictive in identifying bona fide isolated intradiscal lesions primarily causing chronic serious LBP illness in this first study comparing discography results to a gold standard.
11-24-06: Discography's False Positive Rate: revisited:
Carragee EJ, Alamin TF, Carragee JM. “Low-pressure positive Discography in subjects asymptomatic of significant low back pain illness.” Spine. 2006 Mar 1;31(5):505-9.
Orthopaedic Surgery Division, Stanford University, Stanford, CA 94305, USA.
STUDY DESIGN: Retrospective data review of positive disc injections at low pressures among subjects without chronic low back pain (LBP) illness compared to patients with chronic LBP undergoing Discography. OBJECTIVE: To test the hypothesis that false-positive injections during Discography can effectively be eliminated by defining the positive injection criteria to include only those discs in which pain is produced with low injection pressure injections. SUMMARY OF BACKGROUND DATA: The use of lumbar Discography as a diagnostic tool remains controversial. Studies have shown that disc injections among subjects asymptomatic of clinical LBP will produce painful injections in a significant proportion of subjects, rendering the interpretation of positive diskograms in clinical practice problematic. It has been argued that lumbar disc injections at low pressure may be clinically different from those at higher pressure and that a guideline accepting only of low-pressure injections will effectively eliminate false positives. METHODS: A total of 69 volunteers with no clinically significant LBP undergoing experimental lumbar Discography were analyzed. There were 4 subgroups of this study cohort: no LBP, no chronic pain (n = 10); no LBP, chronic pain (n = 14); no LBP, previous lumbar discectomy (n = 20); and minor benign "backache" (n = 25). Pressure measurements during injection were made, and the pressure at which a significant pain response was elicited was recorded. This result was compared to the pain response and pressure profiles of 52 patients undergoing Discography for chronic LBP illness in consideration of treatment. Raters who were blinded to the subject's study group scored the studies. Diskogram morphology, pain response, and concordance, as well as magnetic resonance imaging, plain radiographs, psychometric testing (Distress and Risk Assessment Method), and compensation history were documented for each group. A low-pressure positive was defined as significant pain elicited less than 22 psi more than opening pressure. RESULTS: The number and percent of individuals with at least 1 low-pressure positive disc in the experimental group were 17 of 69 (25%) and in the clinical LBP group 14 of 52 (27%). The percentage of subjects with positive pain in the different experimental subgroups was: no LBP, no chronic pain 0/10 (0%); no LBP, chronic pain 5/14 (36%); no LBP, previous lumbar discectomy 5/20 (25%); and minor benign "backache" 7/25 (28%). Positive injections correlated with anular disruption, abnormal psychometric findings, and chronic pain states. CONCLUSIONS: The analysis shows that the rate of low-pressure painful injections in subjects without chronic LBP illness is approximately 25%, and correlates with both anatomic and psychosocial factors. In certain subgroups, this may represent an unacceptable risk of false-positive results.
11-24-06: Infliximab, as an off-lable (and very expensive) treatment for sciatica, does not bode well in this randomized controlled trial into its efficacy.
Korhonen T, Karppinen J, Paimela L, "The treatment of disc herniation-induced sciatica with infliximab: one-year follow-up results of FIRST II, a randomized controlled trial." Spine. 2006 Nov 15;31(24):2759-66.
Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Oulu, Finland.
STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To evaluate the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha), in patients with acute/subacute sciatica secondary to herniated disc.
SUMMARY OF BACKGROUND DATA: The results of experimental studies and our open-label trial support the use of infliximab in sciatica. Here we report the 1-year results of a randomized controlled trial (FIRST II, Finnish Infliximab Related STudy) evaluating the efficacy and safety of a single infusion of infliximab for sciatic pain. METHODS: Inclusion criteria were unilateral sciatic pain with a disc herniation concordant with the symptoms and signs of radicular pain. Patients had to be candidates for discectomy. Criteria for discectomy included (in addition to a symptomatic disc herniation on MRI) neural entrapment (straight leg raising [SLR] < or =60 degrees ) with either a short-term (2-4 weeks) severe or long-term (4-12 weeks) moderate leg pain. Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo. Differences in the clinical examination parameters (straight leg raise [SLR], muscle strength, sensory defects, tendon reflexes), patient-reported symptoms (leg and back pain using a visual analog scale [VAS], Oswestry disability, quality-of-life [RAND-36]), sick leaves, number of discectomies, and adverse effects between the two treatment groups over the 1-year follow-up were compared using Mann-Whitney U test or Student's t test, repeated-measures analysis, or Cox proportional hazards model. Logistic regression was used to assess the predictors of good response. RESULTS: Sixty-seven percent (76%) of patients in the infliximab group reported no pain at 52 weeks compared with 63% in the control group (P = 0.72). Similar efficacy was observed between treatment groups for other outcomes. Eight patients in each group required surgery. Three nonserious adverse reactions were encountered in the infliximab group. The response (irrespective of the treatment) was significantly better with shorter symptom duration and less SLR restriction at baseline. Patients in the infliximab group appeared to especially benefit in cases of a L4-L5 (or L3-L4) herniation and if a Modic change was colocalized at the symptomatic level. CONCLUSIONS: Although the long-term results of this randomized trial do not support the use of infliximab compared with placebo for lumbar radicular pain in patients with disc herniation-induced sciatica, further study in a subgroup of patients with L4-L5 or L3-L4 herniations, especially in the presence of Modic changes, appears to be warranted.
11-24-06: In a well done and rare randomized controlled trial, CHARITE (An artificial disc) demonstrates efficacy equal to anterior interbody fusion with a few perks.
Blumenthal S, McAfee PC, Guyer RD, et al. "A prospective, randomized, multicenter Food and Drug Administration investigational device exemptions study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part I: evaluation of clinical outcomes." Spine. 2005 Oct 15;30(20):2356. and Spine. 2005 Jul 15;30(14):1565-75; discussion E387-91.
Texas Back Institute, Plano, Texas 75093, USA. [email]email@example.com[/email]
STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.
OBJECTIVES: The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement, using the CHARITE artificial disc (DePuy Spine, Raynham, MA), with anterior lumbar interbody fusion, for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment. SUMMARY OF BACKGROUND DATA: Reported results of lumbar total disc replacement have been favorable, but studies have been limited to retrospective case series and/or small sample sizes. METHODS: Three hundred four (304) patients were enrolled in the study at 14 centers across the United States and randomized in a 2:1 ratio to treatment with the CHARITE artificial disc or the control group, instrumented anterior lumbar interbody fusion. Data were collected pre- and perioperatively at 6 weeks and at 3, 6, 12, and 24 months following surgery. The key clinical outcome measures were a Visual Analog Scale assessing back pain, the Oswestry Disability Index questionnaire, and the SF-36 Health Survey. RESULTS: Patients in both groups improved significantly following surgery. Patients in the CHARITE artificial disc group recovered faster than patients in the control group. Patients in the CHARITE artificial disc group had lower levels of disability at every time interval from 6 weeks to 24 months, compared with the control group, with statistically lower pain and disability scores at all but the 24 month follow-up (P < 0.05). At the 24-month follow-up period, a significantly greater percentage of patients in the CHARITE artificial disc group expressed satisfaction with their treatment and would have the same treatment again, compared with the fusion group (P < 0.05). The hospital stay was significantly shorter in the CHARITE artificial disc group (P < 0.05). The complication rate was similar between both groups. CONCLUSIONS: This prospective, randomized, multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITE artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion. These results support earlier reports in the literature that total disc replacement with the CHARITE artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients. The CHARITE artificial disc group demonstrated statistically significant superiority in two major economic areas, a 1-day shorter hospitalization, and a lower rate of reoperations (5.4% compared with 9.1%). At 24 months, the investigational group had a significantly higher rate of satisfaction (73.7%) than the 53.1% rate of satisfaction in the control group (P = 0.0011). This prospective randomized multicenter study also demonstrated an increase in employment of 9.1% in the investigational group and 7.2% in the control group.
08-30-06: Thirty-Three Percent (33%) Failure Rate for Disc Surgery:
Although this study certainly wasn't of the best design, I found it interesting and believable: "One out of three patients operated of herniated lumbar disc in our area presented failed disc surgery..."
Neurocirugia (Astur). 2005 Dec;16(6):507-17.
[Original Article in Spanish]
Rodriguez-Garcia J, Sanchez-Gastaldo A, Ibanez-Campos T, Vazquez-Sousa C, Cantador-Hornero M, Exposito-Tirado JA, Cayuela-Dominguez A, Echevarria-Ruiz de Vargas C.
Servicio de Rehabilitacion. Hospitales Universitarios Virgen del Rocio. Sevilla.
INTRODUCTION. The surgery for herniated disc is the most common operation at the level of the lumbar spine. The failed surgery rates range between 10% and 40%, conforming what is known as Failed Back Surgery Syndrome (FBSS). Return to work after surgery occurs in 70-85% of the cases. There are a few studies analysing the quality of life after the operation. The aims of this study are to know the incidence of the herniated disc lumbar failed surgery in our area, identify those factors influencing its development, and study behavioural parameters as the return to work and the quality of life at a middle term after surgery, also its relation with the success or failure surgery.
MATERIAL AND METHODS.
A descriptive transversal study of 117 patients operated for herniated lumbar disc during the first six months of the year 2003 is reported. In order to evaluate the incidence of failed surgery and the related factors, the clinical records were retrospectively analyzed. Ninety one patients were interviewed by phone using the Health Questionnaire SF-36, in order to analyze the non clinical factors related to FBSS, such as labour reincorporation, satisfaction with surgery, realization of rehabilitation treatment and quality of life after surgery. For the statistical analysis of the results, we used the program SPSS 11.01.
In a sample in which the proportion between both sexes was 1/1, and the middle age was over 45 years [35-54], in which the most frequent clinical symptom was right sciatica, lasting more than 6 months, correlated to disc herniation at L5-S1 level, 37.9% of the patients presented FBSS. Although there were a few patients with reoperation in our study, the incidence of FBSS in these patients was higher (52.9%) than in patients who suffered this surgery for first time (32%). The predictive clinical factors of an unfavourable result in patients operated on for first time were bilateral sciatica, the presence of stenosis associated to herniated disc and comorbidity factors. On the other hand the sociolabor factors identified were a low culture level and those working as drivers, building and service sectors. Return to work occurred in the 64% of the active workers before surgery. Only around 10% of patients were dissatisfied with surgical result and there was a significant relationship between this and the physical function, pain, vitality and emotional status in the SF-36 with the FBSS.
One out of three patients operated of herniated lumbar disc in our area presented failed disc surgery and the return to work occurred in 2 out of three patients active before the operation. The failed surgery patient suffers from pain, that interferes and limits the labour and home activities. Furthermore, the patient presents frequent sensation of fatigue and exhaustion and also emotional problems that contribute to interfere with work and activities of the daily life.
02-16-06: IDET Takes another pounding as a double-blind trial fails to demonstrate efficacy (that it works): (Here's another negative study)
This is a pretty good one; two groups of discogenic confirmed back pain sufferers were prepped for the IDET procedure. (The needle was even inserted into the disc and covered the annular tear.) Then, group (arm) #1 got the real IDET (turned on the heat generator and the disc was cooked in attempts to seal the annular tear). In group #2, the heat generator was NOT turned on; hence, this group got a fake IDET procedure (the disc was not heated). There were no differences, in terms of improvement, between the fake IDET versus the real IDET at six months.
Freeman BJ, Fraser RD, et al. "A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain." Spine. 2005 Nov 1;30(21):2369-77; discussion 2378.
Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, South Australia. firstname.lastname@example.org
STUDY DESIGN: A prospective, randomized, double-blind, placebo-controlled trial of intradiscal electrothermal therapy (IDET) for the treatment of chronic discogenic low back pain (CDLBP). OBJECTIVES: To test the safety and efficacy of IDET compared with a sham treatment (placebo). SUMMARY OF BACKGROUND DATA: In North America alone, more than 40,000 intradiscal catheters have been used to treat CDLBP. The evidence for efficacy of IDET is weak coming from retrospective and prospective cohort studies providing only Class II and Class III evidence. There is one study published with Class I evidence. This demonstrates statistically significant improvements following IDET; however, the clinical significance of these improvements is questionable. METHODS: Patients with CDLBP who failed to improve following conservative therapy were considered for this study. Inclusion criteria included the presence of one- or two-level symptomatic disc degeneration with posterior or posterolateral anular tears as determined by provocative computed tomography (CT) discography. Patients were excluded if there was greater than 50% loss of disc height or previous spinal surgery. Fifty-seven patients were randomized with a 2:1 ratio: 38 to IDET and 19 to sham procedure (placebo). In all cases, the IDET catheter was positioned to cover at least 75% of the annular tear as defined by the CT discography. An independent technician connected the catheter to the generator and then either delivered electrothermal energy (active group) or did not (sham group). Surgeon, patient, and independent outcome assessor were all blinded to the treatment. All patients followed a standard postprocedural rehabilitation program. Independent statistical analysis was performed. OUTCOME MEASURES: Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), Short Form 36 questionnaire (SF-36), Zung Depression Index (ZDI), and Modified Somatic Perceptions Questionnaire (MSPQ) were measured at baseline and 6 months. Successful outcome was defined as: no neurologic deficit, improvement in LBOS of greater then 7 points, and improvement in SF-36 subsets (physical function and bodily pain) of greater than 1 standard deviation. RESULTS: Baseline demographic data, initial LBOS, ODI, SF-36, ZDI, and MSPQ were similar for both groups. No neurologic deficits occurred. No subject in either arm showed improvement of greater than 7 points in LBOS or greater than 1 standard deviation in the specified domains of the SF-36. Mean ODI was 41.42 at baseline and 39.77 at 6 months for the IDET group, compared with 40.74 at baseline and 41.58 at 6 months for the placebo group. There was no significant change in ZDI or MSPQ scores for either group. CONCLUSIONS: The IDET procedure appeared safe with no permanent complications. No subject in either arm [group] met criteria for successful outcome. Further detailed analyses showed no significant change in outcome measures in either group at 6 months. This study demonstrates no significant benefit from IDET over placebo.
01-20-06: Infliximab, once touted as the miracle cure for sciatica, appears not to be miraculous after all as it was no more effective than placebo for treating a group of sciatic sufferers.
Korhonen T, Karppinen J, et al. "The treatment of disc herniation-induced sciatica with infliximab: results of a randomized, controlled, 3-month follow-up study." Spine 2005 Dec 15;30(24):2724-8.
Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Oulu, Finland.
STUDY DESIGN: A randomized controlled trial. OBJECTIVES: To evaluate the efficacy of infliximab, a monoclonal antibody against tumor necrosis factor (TNF)-alpha in a randomized controlled setting. SUMMARY OF BACKGROUND DATA: Recently, we obtained encouraging results in an open-label study of infliximab in patients with disc herniation-induced sciatica. Furthermore, the results of experimental studies support the use of infliximab in sciatica. Therefore, we initiated a randomized, controlled trial (FIRST II, Finnish Infliximab Related STudy) to confirm the efficacy of a single infusion of infliximab for sciatic pain. METHODS: Inclusion criteria were unilateral moderate to severe sciatic pain with an MRI-confirmed disc herniation concordant with the symptoms and signs of radicular pain. Patients had to be candidates for discectomy, as evaluated by an independent orthopedic surgeon. Forty patients were allocated to a single intravenous infusion of either infliximab 5 mg/kg or placebo. Assessments at baseline and various time points included clinical examination with measurement of straight leg raising restriction; questionnaires related to subjective symptoms (leg and back pain by 100-mm visual analog scale, Oswestry disability); sick leaves; number of discectomies; and adverse effects possibly related to treatment. The primary endpoint was a reduction in leg pain from baseline to 12 weeks, which was analyzed using a Mann-Whitney U test and repeated-measures analysis. RESULTS: A significant reduction in leg pain was observed in both groups, with no significant difference between treatment regimens. Similar efficacy was observed between treatment groups for secondary endpoints. Seven patients in each group required surgery. No adverse effects related to treatment were encountered. CONCLUSIONS: The results of this randomized trial do not support the use of infliximab for lumbar radicular pain in patients with disc herniation-induced sciatica.
12-16-05: Willow Bark as effective as Vioxx for acute low back pain?
Just when I thought I've heard it all, Bogduk (my hero) states that Willow Bark is just as effective at alleviating acute back pain as Vioxx (which was probably the best drug I've ever tried for back and leg pain) and even list a few randomized controlled trials to support his claim:
Chrubasik S, Kunzel O, Model A, Conradt C, Black A. "Treatment of low back pain with a herbal or synthetic anti-rheumatic: a randomized controlled study. Willow bark extract for low back pain." Rheumatology (Oxford). 2001 Dec;40(12):1388-93.
Herbal Medicines Research and Education Centre, University of Sydney, Sydney, NSW 2006, Australia.
OBJECTIVES: To compare the effects of a proprietary extract of willow bark (Assalix) and a selective inhibitor (rofecoxib) of the enzyme cyclo-oxygenase-2 (COX-2). METHODS: An open, randomized, post-marketing study was carried out in an out-patients clinic on two groups of patients aged 18 to 80 yr presenting over a 6-month period with acute exacerbations of low back pain. Using computer-generated random list, 114 patients were allocated to receive a daily dose of herbal extract containing 240 mg of salicin [PAID (phyto-anti-inflammatory drug) group] and 114 were allocated to receive 12.5 mg of the synthetic COX-2 inhibitor rofecoxib [NSAID (non-steroidal anti-inflammatory drug) group]. The doses were chosen according to existing recommendations. All patients were free to use whatever additional conventional treatments were thought necessary. The outcome measures were a modified Arhus index, its pain component and the Total Pain Index. RESULTS: Groups were well matched. After 4 weeks of treatment, the Arhus index had improved by about 20%, its pain component by about 30% and the Total Pain Index by about 35%. The number of pain-free patients (visual analogue scale score <2) was about 20 in each group. About 60% of the patients in each group responded well to the treatment (as judged by an improvement of >/=30% in the Total Pain Index relative to its baseline). The improvement was also reflected reasonably well in the physicians' and patients' judgements of the effectiveness of treatment, which were largely concordant. Few patients of either group resorted to the additional conventional treatment options. The incidence of adverse events was similar in the two groups. Treatment with rofecoxib was about 40% more expensive than that with Assalix. CONCLUSION: There was no significant difference in effectiveness between the two treatments at the doses chosen. Treatment with Assalix was less expensive.
Randomized Controlled Trial
12-16-05: 35% of failed fusion patients RESPONDED to a simple block of the sacroiliac joint!
It's a French study (which I always take with a grain of salt); however, eye opening:
They took a group of failed lumbar fusion patients, blocked the SI joints, and found that 35% of them got pain relief! Wow! I shall for sure get my SI joints blocked [b]before[/b] undergoing fusion.
Maigne JY, Planchon CA. "Sacroiliac joint pain after lumbar fusion. A study with anesthetic blocks." Eur Spine J. 2005 Sep;14(7):654-8. Epub 2005 Mar 11.
Low back pain persisting or appearing after a technically successful lumbar fusion challenges clinicians. In this context, the sacroiliac joint could be a possible source of pain, but the frequency of its responsibility is not really known. We used sacroiliac anesthetic blocks, the gold standard for diagnosis, to determine this frequency. Our second goal was to search predictive factors for a positive block. Our prospective series consisted of 40 patients with persistent low back pain after a technically successful fusion who received a sacroiliac anesthetic block under fluoroscopic control. The diagnostic criterion was a relief of more than 75% of the pain on a visual analog scale. We found a 35% rate of positive blocks. The only criterion that characterized these patients was a postoperative pain different from the preoperative pain in its distribution ( p =0.017). A free interval of more than 3 months between surgery and appearance of the pain had an indicative value ( p =0.17). An increased uptake in the sacroiliac on bone scintigraphy or a past history of posterior iliac bone-graft harvesting had no significant value ( p =0.74 and p =1.0, respectively). The sacroiliac joint is a possible source of pain after lumbar fusion. The anesthetic block under fluoroscopic control remains the gold standard.[/quote]
12-04-05: Radio-frequency Annuloplasty: A supportive prospective trial demonstrates efficacy: discTRODE [better & safer than IDET?]
Finch PM, Price LM, Drummond PD. "Radiofrequency heating of painful annular disruptions: one-year outcomes." J Spinal Disord Tech. 2005 Feb;18(1):6-13.
OBJECTIVE: Although several studies have reported on outcomes following heating of annular tears with a thermoresistive catheter (SpineCATH), no data are available on the efficacy of thermal treatment with a flexible radiofrequency electrode (discTRODE). A prospective case-control study was conducted to determine the efficacy of radiofrequency heating of painful annular tears in the lumbar spine. METHODS: After at least 6 months of conservative treatment, 46 patients were studied for the presence of single-level painful annular tears with magnetic resonance imaging and provocative discography. Thirty-one patients underwent heating of their annular tears with a flexible radiofrequency electrode placed across the posterior annulus. The remaining 15 patients, who mostly could not obtain funding for the procedure, continued with conservative management and acted as a control group. The Visual Analogue Scale (VAS), Oswestry Disability Index (ODI), and Medication Quantification Score (MQS) were obtained before and at 3-monthly intervals after treatment. RESULTS: The VAS decreased significantly after the radiofrequency treatment, and this decrease persisted at 12 months of follow-up. The VAS did not change over 12 months in untreated control subjects. The decrease in VAS was significantly greater in the treated patients than the control subjects. The ODI also decreased in treated patients but not in control subjects. The MQS did not change in either group over the 12-month follow-up period. CONCLUSIONS: Radiofrequency heating of annular tears can lead to an improvement in the pain of internal disc disruption. The improvement gained by this treatment method is significantly better than that obtained from conservative management.
11-20-05: Other Less Obvious Causes of SCIATICA:
Filler AG, Haynes J, et al. "Sciatica of nondisc origin and piriformis syndrome: diagnosis by magnetic resonance neurography and interventional magnetic resonance imaging with outcome study of resulting treatment." J Neurosurg Spine. 2005 Feb;2(2):99-115.
Institute for Spinal Disorders, Cedars Sinai Medical Center, Los Angeles, California, USA. email@example.com
OBJECT: Because lumbar magnetic resonance (MR) imaging fails to identify a treatable cause of chronic sciatica in nearly 1 million patients annually, the authors conducted MR neurography and interventional MR imaging in 239 consecutive patients with sciatica in whom standard diagnosis and treatment failed to effect improvement. METHODS: After performing MR neurography and interventional MR imaging, the final rediagnoses included the following: piriformis syndrome (67.8%), distal foraminal nerve root entrapment (6%), ischial tunnel syndrome (4.7%), discogenic pain with referred leg pain (3.4%), pudendal nerve entrapment with referred pain (3%), distal sciatic entrapment (2.1%), sciatic tumor (1.7%), lumbosacral plexus entrapment (1.3%), unappreciated lateral disc herniation (1.3%), nerve root injury due to spinal surgery (1.3%), inadequate spinal nerve root decompression (0.8%), lumbar stenosis (0.8%), sacroiliac joint inflammation (0.8%), lumbosacral plexus tumor (0.4%), sacral fracture (0.4%), and no diagnosis (4.2%). Open MR-guided Marcaine injection into the piriformis muscle produced the following results: no response (15.7%), relief of greater than 8 months (14.9%), relief lasting 2 to 4 months with continuing relief after second injection (7.5%), relief for 2 to 4 months with subsequent recurrence (36.6%), and relief for 1 to 14 days with full recurrence (25.4%). Piriformis surgery (62 operations; 3-cm incision, transgluteal approach, 55% outpatient; 40% with local or epidural anesthesia) resulted in excellent outcome in 58.5%, good outcome in 22.6%, limited benefit in 13.2%, no benefit in 3.8%, and worsened symptoms in 1.9%. CONCLUSIONS: This Class A quality evaluation of MR neurography's diagnostic efficacy revealed that piriformis muscle asymmetry and sciatic nerve hyperintensity at the sciatic notch exhibited a 93% specificity and 64% sensitivity in distinguishing patients with piriformis syndrome from those without who had similar symptoms (p < 0.01). Evaluation of the nerve beyond the proximal foramen provided eight additional diagnostic categories affecting 96% of these patients. More than 80% of the population good or excellent functional outcome was achieved.
11-20-05: Discography complication: Acute Disc Herniation.
Provocation discography is certainly not a test to be taken lightly and should NEVER be performed unless the patient has agreed to have surgery. Here's a tiny investigation that reports five cases of acute disc herniation following the discography procedure that required surgical decompression to fix:
Poynton AR, Hinman A, et al. "Discography-induced acute lumbar disc herniation: a report of five cases." J Spinal Disord Tech. 2005 Apr;18(2):188-92.
Department of Spinal Surgery, Hospital for Special Surgery, New York, NY, USA. firstname.lastname@example.org
The reported complication rate of provocative lumbar discography is low, ranging from 0-2.5%. We report five cases of acute lumbar disc herniation precipitated by discography, a previously unreported complication. The cases reported comprise of four men and one woman with ages ranging from 23-45 years. All developed an acute exacerbation of radicular leg pain following multilevel provocative lumbar discography. One patient developed an acute foot drop. Comparison of lumbar MRI scans before and after discography demonstrated either a new herniated disc fragment or an increase in size of a preexisting herniation in all cases. On review of each discogram study and pre-discogram MRI an annular tear or small disc herniation was noted in all cases. In each case the patients' symptoms failed to resolve necessitating surgical intervention in all cases. In conclusion, annular deficiency is an obvious predisposing factor to discogram related disc herniation. New onset or a persistent exacerbation of radicular symptoms following provocative discography merits further investigation.
11-20-05: Possible new Sciatica Indicator: E-selectin
Sen O, Aydin MV, et al. "Can E-selectin be a reliable marker of inflammation in lumbar disc disease?" Neurosurg Rev. 2005 Jul;28(3):214-7
Department of Neurosurgery, Baskent University, 01250 Yuregir, Adana, Turkey. email@example.com
The cause of sciatica and low back pain associating with lumbar disc herniation has not been clearly identified until now. Inflammation has been shown to occur via immunohistochemical and biochemical methods in herniated disc tissues. The important prognostic role of E-selectin has recently been substantiated by other studies in early rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA). The important role of adhesion molecules in the initiation and progression of the inflammatory response is well known for infectious diseases and autoimmune disorders. In our study, we aimed to show the role of E-selectin as an inflammatory marker and the correlation of inflammation with straight-leg raise (SLR) test findings and subtype of disc herniation. We found that the cases with positive SLR test had higher rates of immunostaining with E-selectin. This led us to think that E-selectin might play an important role in the activity status of the disease, meaning patients with more limited movement capacity might benefit from E-selectin antagonist therapy. Among the many studies performed to identify the relationship between the inflammation markers and activity of lumbar disc herniation, this is the first investigation held with E-selectin.
Eur Spine J. 2005 Oct 18; [Epub ahead of print]
Lumbar disk herniation with contralateral symptoms.
Sucu HK, Gelal F.
Department of Neurosurgery, Izmir Ataturk Research and Training Hospital, Izmir, Turkey, firstname.lastname@example.org.
The aim of the study is to determine if leg pain can be caused by contralateral lumbar disk herniation and if intervention from only the herniation side would suffice in these patients. Five patients who had lumbar disk herniations with predominantly contralateral symptoms were operated from the side of disk herniation without exploring or decompressing the symptomatic side. Patients were evaluated pre- and postoperatively. To our knowledge, this is the first reported series of such patients who were operated only from the herniation side. The possible mechanisms of how contralateral symptoms predominate in these patients are also discussed. In all patients, the shape of disk herniations on imaging studies were quite similar: a broad-based posterior central-paracentral herniated disk with the apex deviated away from the side of the symptoms. The symptoms and signs resolved in the immediate postoperative period. Our data clears that sciatica can be caused by contralateral lumbar disk herniation. When operation is considered, intervention only from the herniation side is sufficient. It is probable that traction rather than direct compression is responsible from the emergence of contralateral symptoms. (I guess I should probably by this one to review it further, or somebody could sent it to me... for a change.)
10-15-05: Wonderful Intro Explaining Central Sensitization:
Caudle RM, et al. "Spinal cord NR1 serine phosphorylation and NR2B subunit suppression following peripheral inflammation." Mol Pain. 2005 Sep 2;1:25. [Free article, here]
Central sensitization is a form of plasticity (structural chance within the spinal cord) in the spinal cord that alters the input/output relationship of the neuronal pain processing circuitry. Central sensitization is symptomatically expressed as allodynia, pain to normally non-painful stimuli, and hyperalgesia, an enhanced sensation of pain to typically painful stimuli.
When an individual is injured, central sensitization encourages the protection of the injured area by enhancing the pain experience. The individual is then motivated to guard the damaged tissue until it is healed. As a rule, central sensitization will be reversed as the injury heals. However, on occasion it fails to resolve and becomes the patient's primary disease. This disease is referred to as chronic pain. Thus, the molecular processes that induce and reverse central sensitization are important to understanding, preventing and
treating chronic pain. Recent work on pain processing has highlighted the central role of N-methyl-D-aspartate (NMDA) receptors in central sensitization. NMDA receptors were found to play a major role in hyperalgesia, allodynia, and expanded receptive fields when central sensitization had been induced by peripheral injury [1-5]. These findings using NMDA receptor antagonists indicated that NMDA receptors initiated events that lead to neuronal plasticity in the spinal cord and that the NMDA receptors themselves participated in the maintenance of central sensitization. Central sensitization is the result of an increase in intracellular calcium, which enhances synaptic inputs from primary nociceptors. NMDA receptors conduct much of this calcium from the extracellular space through their ionophore. The net effect of the increased calcium is an increased number of effective synapses on dorsal horn neurons and enhanced neuronal excitability [1,6,7].
Central sensitization, it must be noted, is distinct from the frequently studied phenomenon of windup, which is rapidly reversed when the peripheral stimulus ceases. Windup is produced by the well documented voltage dependent magnesium block of the NMDA receptor's ion channel. The magnesium block enables the receptor to integrate nociceptive signals that arrive in the spinal cord via C-fibers. The net result of the integration is that the later stimuli in a series produces greater responses in dorsal horn neurons even when the stimuli are identical to the first event [8-10]. Windup does not lead to a prolonged enhancement of dorsal horn neuronal excitability like central sensitization, but may induce central sensitization by increasing intracellular calcium levels. Thus, although NMDA receptors are involved in both central sensitization and windup their role in the two processes is distinct .
The involvement of spinal cord N-methyl-D-aspartate (NMDA) receptors in hyperalgesia and allodynia is well documented in the literature [ 2-5 19-21]. However, the mechanisms by which the receptors mediate the development and maintenance of allodynia and hyperalgesia in a chronic pain state are not well understood. Long lasting changes in the NMDA receptors either through post-translational modifications or expression of different subunits may lead to a chronic enhancement of nociception.
Here's the abstract:
BACKGROUND: Spinal cord N-methyl-D-aspartate (NMDA) receptors are intimately involved in the development and maintenance of central sensitization. However, the mechanisms mediating the altered function of the NMDA receptors are not well understood. In this study the role of phosphorylation of NR1 splice variants and NR2 subunits was examined following hind paw inflammation in rats. We further examined the level of expression of these proteins following the injury. RESULTS: Lumbar spinal cord NR1 subunits were found to be phosphorylated on serine residues within two hours of the induction of hind paw inflammation with carrageenan. The enhanced NR1 serine phosphorylation reversed within six hours. No phosphorylation on NR1 threonine or tyrosine residues was observed. Likewise, no NR2 subunit phosphorylation was observed on serine, threonine or tyrosine residues. An analysis of NR1 and NR2 protein expression demonstrated no change in the levels of NR1 splice variants or NR2A following the inflammation. However, spinal cord NR2B expression was depressed by the hind paw inflammation. The expression of NR2B remained depressed for more than one week following initiation of the inflammation. CONCLUSION: These data suggest that NR1 serine phosphorylation leads to an initial increase in NMDA receptor activity in the spinal cord following peripheral injury. The suppression of NR2B expression suggests compensation for the enhanced nociceptive activity. These data indicate that spinal cord NMDA receptors are highly dynamic in the development, maintenance and recovery from central sensitization following an injury. Thus, chronic pain therapies targeted to NMDA receptors should be designed for the exact configuration of NMDA receptor subunits and post-translational modifications present during specific stages of the disease.
10-11-05: 32% Complain of MORE pain 12 months after IDET; 1 patient suffers severe infection.
Park SY, Moon SH, "Intradiscal electrothermal treatment for chronic lower back pain patients with internal disc disruption." Yonsei Med J. 2005 Aug 31;46(4):539-45.
Department of Orthopedic Surgery, Yonsei University College of Medicine, 134 Shinchon-dong, Seodaemun-gu, Seoul 120-752, Korea. email@example.com. [free download of paper HERE in .pdf format.]
Chronic lower back pain is one of the most common musculoskeletal problems; it is also the most expensive industrial injury. Not surprisingly, many treatments have been developed to combat this expensive and debilitating condition. One of these, intradiscal electrothermal treatment (IDET), was developed for patients with chronic discogenic lower back pain who failed to improve with any of the wide variety of non- surgical treatments. The present study sought to evaluate the efficacy of IDET for patients with chronic lower back pain. Twenty-five patients were enrolled in this prospective study; the patients received IDET between June 2001 and June 2003. MRI was used to confirm the diagnosis of internal disc disruption in all patients. The patients then underwent a pre-operative provocative test and discography. The follow-up duration was at least 1 year in all cases, and the visual analogue scale, recovery rate, and satisfaction of each patient were evaluated. The average age of the patients was 32 years (age range 18 to 49 years), and the patient group was 33% male and 67% female. Of the 25 patients, 5 underwent lumbar fusion surgery within 1 year of IDET. After IDET, 8 patients (32%) reported more pain than before, 14 patients (56%) reported less pain, and 3 patients (12%) experienced no change. Twelve patients (48%) were satisfied with IDET, 11 (44%) were dissatisfied, and 2 (8%) were undecided about the treatment. At least 1 year after IDET, nearly half the study patients were dissatisfied with their medical outcome. Consequently, 5 patients (20%) underwent fusion surgery at 1 year after IDET. Although other studies have shown good results with IDET for at least 2 years, this investigation suggests the IDET may be somewhat less effective. In order to firmly establish the efficacy of IDET for treating chronic discogenic lower back pain, additional studies with larger numbers of patients evaluated over longer time periods are recommended.
10-08-05: Adding Fat after Discectomy Betters Clinical Outcome.
Another interesting randomized controlled trial that demonstrated - according to these Italian researchers - adding fat into the epidural space after discectomy yielded a better clinical outcome at one year status-post.
Gambardella G, Gervasio O, Zaccone C, Puglisi E. "Prevention of recurrent radicular pain after lumbar disc surgery: a prospective study." Acta Neurochir Suppl. 2005;92:151-4.
BACKGROUND: Postoperative epidural fibrosis is a major causative factor of low-back pain even if microsurgical techniques are adopted to reduce this phenomenon. To prevent the recurrent radicular pain caused by this problem, we utilized adipose tissue drawn from the same patient; at the end of surgical procedure, the fat was placed around the spinal root or the dural sac. This procedure was evaluated by a prospective, randomised study. METHOD: From 180 patients operated on for lumbar discectomy between January 2000 to December 2001, 74 were enclosed in the study. In 37 patients, the spinal root was covered by autologous fat (group A), in the other 37 (control group, B), this procedure was not adopted. One year after surgery, all the patients were evaluated with clinical and radiological (Magnetic Resonance Imaging) follow-up. Only two patients were lost to follow-up. FINDINGS: 71% of the patients in group A had 100% of clinical and radiological post-operative outcome score; this result was obtained only in 35% of the patients in group B. A clinical score evaluating pain syndrome (from grade 0 to 5) and a radiological score evaluating postoperative fibrosis (from grade 0 to 4) was adopted. Therefore, group A had best outcome as compared to control group. CONCLUSIONS: The authors found a positive effect in the reconstruction of epidural fat with autograft of adipose tissue to prevent postoperative scarring and failed-back syndrome related to postoperative fibrosis.
10-08-05: Endoscopic Adhesiolysis: RCT for Chronic Back Pain.
Manchikanti L, Boswell MV, "A randomized, controlled trial (RCT) of spinal endoscopic adhesiolysis in chronic refractory low back and lower extremity pain." BMC Anesthesiol. 2005 Jul 6;5:10.
BACKGROUND: Postoperative epidural fibrosis may contribute to between 5% to 60% of the poor surgical outcomes following decompressive surgery. Correlations have been reported between epidural scarring and radicular pain, poor surgical outcomes, and a lack of any form of surgical treatment. The use of spinal endoscopic adhesiolysis in recent years in the management of chronic refractory low back and lower extremity pain has been described. METHODS: A prospective, randomized, double-blind trial was conducted to determine the outcome of spinal endoscopic adhesiolysis to reduce pain and improve function and psychological status in patients with chronic refractory low back and lower extremity pain. A total of 83 patients were evaluated, with 33 patients in Group I and 50 patients in Group II. Group I served as the control, with endoscopy into the sacral level without adhesiolysis, followed by injection of local anesthetic and steroid. Group II received spinal endoscopic adhesiolysis, followed by injection of local anesthetic and steroid. RESULTS: Among the 50 patients in the treatment group receiving spinal endoscopic adhesiolysis, significant improvement without adverse effects was shown in 80% at 3 months, 56% at 6 months, and 48% at 12 months. The control group (non-adhesiolysis group) showed improvement in 33% of the patients at one month and none thereafter. Based on the definition that less than 6 months of relief is considered short-term and longer than 6 months of relief is considered long-term, a significant number of patients obtained long-term relief with improvement in pain, functional status, and psychological status. CONCLUSION: Spinal endoscopic adhesiolysis with targeted delivery of local anesthetic and steroid is an effective treatment in a significant number of patients with chronic low back and lower extremity pain without major adverse effects.
Here's the Full Free Investigation: Spinal Endoscopic Adhesiolysis and here's a Adobe .PDF download in case the authors withdraw this free-bee: Spinal endoscopic Adhesiolysis.PDF.
10-05-05: O2 & O3 Gas More Effective than Traditional ESI?
Bonetti M, Fontana A, Cotticelli B, et al. "Intraforaminal O(2)-O(3) versus periradicular steroidal infiltrations in lower back pain: randomized controlled study." AJNR Am J Neuroradiol. 2005 May;26(5):996-1000. Department of Neuroradiology and Division of Neurology, Istituto Clinico Citta di Brescia, Italy.
BACKGROUND AND PURPOSE: Reports about steroids and oxygen-ozone therapy to treat lower back pain have been increasing. The purpose of our study was to compare the clinical outcomes in patients treated with infiltrations of O(2)-O(3) gas or steroids at short-, medium-, and long-term follow-up. METHODS: A total of 306 patients (166 with primarily disk disease, 140 with nondisk vertebral disease) with acute or chronic low back and sciatic nerve pain received a CT-guided intraforaminal infiltration of an O(2)-O(3) gas mixture or an periradicular infiltration of steroids. Neurologists unaware of the type of treatment assessed the patients. RESULTS: At 1-week follow-up, most patients had a complete remission of pain, regardless of the treatment. At 6-month follow-up, differences in favor of O(2)-O(3) treatment were significant in patients with disk disease (P = .0021) but not in those without disk disease (P = .0992). Clinical outcomes were poor in 13 (15.1%) of 86 patients receiving O(2)-O(3) infiltration and in 18 (22.5%) of 80 patients receiving steroid injection (P = .2226). Among patients without disk disease, six (8.6%) of 70 patients receiving O(2)-O(3) infiltration but 21.4% of the patients receiving steroid injections had poor outcomes (P = .0332). CONCLUSION: Oxygen-ozone treatment was highly effective in relieving acute and chronic lower back pain and sciatica. The gas mixture can be administered as a first treatment to replace epidural steroids.
10-06-05: Spine Surgeons overly optimistic about outcomes
Graz B, Wietlisbach V, Porchet F, Vader JP. "Prognosis or "curabo effect?": physician prediction and patient outcome of surgery for low back pain and sciatica." Spine. 2005 Jun 15;30(12):1448-52; discussion 1453.
STUDY DESIGN: Prospective study with patient and physician questionnaires, clinical records, and imaging. OBJECTIVE: To compare physician expectations of surgery for sciatica and patient outcome. SUMMARY OF BACKGROUND DATA: Physician accuracy in identifying individual patient prognosis is important for therapeutic decisions. METHODS: A total of 197 consecutive patients with low back pain and/or sciatica who underwent low back surgery in the University Hospital of Lausanne, Switzerland. RESULTS: Physicians predicted "a great improvement" of quality of life after surgery for 79% and "moderate improvement" for 20% (1% others); 39% of patients had no "minimal clinically important difference" in back pain after surgery, despite physician prediction of "great improvement." Correlations between physician expectation and various dimensions of patient outcome were not significant, and agreement with patient global judgment of 1-year outcome was poor (kappa = 0.03). However, in a subgroup where the indication for treatment was not considered appropriate, physician prediction of "great improvement" was followed by greater improvement outcome on SF-36 mental component score (P = 0.05), mental health (0.02), and general health (0.03) compared with patients where the physician did not predict "great improvement." CONCLUSION: Despite clear average improvement, surgeons tended to give overly optimistic predictions that were not correlated with patient outcome. For patients receiving a treatment not meeting explicit criteria of appropriateness, more optimistic physician expectation was associated with better improvement of psychological dimensions. Besides prognostic ability, the influence of physician expectation on patient outcome is discussed and the concept of "curabo effect" (differentiated from "placebo effect") proposed. [Of patients whose surgeon predicted "a great deal of improvement," 56 percent (of the patients) reported no significant improvement in their general health one year after surgery. Whereas surgeons had predicted at least moderate improvement for 99 percent of patients, 39 percent achieved no "minimally clinically important" difference.] Here's some other comments on this paper: Medical News Today
10-06-05: Revision Disc Surgery demonstrates a Good Outcome
Dai LY, Zhou Q, Yao WF, Shen L. "Recurrent lumbar disc herniation after discectomy: outcome of repeat discectomy." Surg Neurol. 2005 Sep;64(3):226-31; discussion 231.
BACKGROUND: Recurrent disc herniation after discectomy is relatively lacking in specific studies and is usually reviewed along with other causes of failed disc surgery. The purpose of the current study was to address the outcome in the patients who had recurrent disc herniation treated with repeat discectomy and to identify the factors that may influence the outcome. METHODS: Thirty-nine patients who underwent repeat discectomy for recurrent lumbar disc herniation were retrospectively analyzed. Of these patients, 27 had recurrent disc herniation at the L4 to L5 level, 11 at the L5 to S1, and 1 at the L3 to L4. They almost had the typical presentation of sciatica. The time from prior discectomy to that of recurrence ranged 6 months to 17 years (average, 5 years and 4 months). The Japanese Orthopaedic Association (JOA) score averaged 12 (range, -3 to 18). All patients had a follow-up evaluation at 1 and 15 years (average, 7 years and 8 months) after surgery. RESULTS: Their JOA score increased to 12 to 29 (average, 24), with the recovery rate of 29% to 100% (average, 72%). Twenty-nine patients (74%) returned to their previous work status or normal daily activity, 7 had significant improvement, and 3 needed analgesic drugs although they had pain relief to different degrees. CONCLUSIONS: The outcomes of repeat discectomy for recurrent disc herniation were satisfactory. No factors such as age, sex, traumatic events, times of prior surgery, level of herniation, side of recurrence, pain-free interval, duration of recurrence symptoms, walking capacity, the preoperative JOA score, associated spinal stenosis, procedures of revision surgery, and dural tear were found to be of predictive value for a prognosis of revision surgery for recurrent disc herniation (P>.05).
10-04-05: Epidural Steroid Injections Not Beneficial
Arden NK, Price C, Reading I, et al. "A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: the WEST study." Rheumatology (Oxford). 2005 Jul 19; [Epub ahead of print]
Objective. To determine the effectiveness and predictors of response to lumbar epidural corticosteroid injections (ESI) in patients with sciatica. We performed a 12-month, multicentre, double-blind, randomized, placebo-controlled, parallel-group trial in four secondary pain-care clinics in the Wessex Region. Methods. Two hundred and twenty-eight patients with a clinical diagnosis of unilateral sciatica of 1-18 months' duration were randomized to either three lumbar ESIs of triamcinolone acetonide or interligamentous saline injections at intervals of 3 weeks. The main outcome measure was the Oswestry low back pain disability questionnaire (ODQ). Results. At 3 weeks, the ESI group demonstrated a transient benefit over the placebo group (patients achieving a 75% improvement in ODQ, 12.5 vs 3.7%; number needed to treat, 11.4). No benefit was demonstrated from 6 to 52 weeks. ESIs did not improve physical function, hasten return to work or reduce the need for surgery. There was no benefit of repeated ESIs over single injection. No clinical predictors of response were found. At the end of the study the majority of patients still had significant pain and disability regardless of intervention. Conclusions. In this pragmatic study, ESIs offered transient benefit in symptoms at 3 weeks in patients with sciatica, but no sustained benefits in terms of pain, function or need for surgery. Sciatica is a chronic condition requiring a multidisciplinary approach. To fully investigate the value of ESIs, they need to be evaluated as part of a multidisciplinary approach.
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