Joshua Levin

Prospective, double-blind, randomized placebo-controlled trials in interventional spine: what the highest quality literature tells us

BACKGROUND CONTEXT The prospective, double-blind, randomized, placebo-controlled study design is essential in the interventional spine literature to truly evaluate whether or not a procedure is effective. PURPOSE This article will critically evaluate the highest quality interventional spine literature with strict interpretation of the results of these trials. STUDY DESIGN Review article. METHODS Extensive Medline/Pubmed searches and searches of the large review articles on the major interventional spine topics were performed to find all prospective, double-blind, randomized placebo-controlled trials in the English language interventional spine literature. RESULTS Fluoroscopically-guided lumbosacral transforaminal epidural corticosteroid injections are effective in the treatment of acute/subacute lumbosacral radicular pain, and in preventing future surgeries. Injection of corticosteroid or Sarapin on the cervical or lumbar medical branch nerves is not effective. When done with proper technique, percutaneous radiofrequency lumbar and cervical medial branch neurotomy are both effective. Intraarticular sacroiliac joint corticosteroid injections are effective in patients with spondyloarthropathy. IDET is modestly effective in the treatment of lumbosacral discogenic pain in carefully selected patients. Percutaneous radio frequency neurotomy of the ramus communicans is effective in the treatment of lumbosacral discogenic pain. No firm conclusions can be drawn about cervical epidural corticosteroid injections, lumbosacral epidural corticosteroid injections for the treatment of chronic radicular pain, cervical or lumbosacral intraarticular zygapophysial joint corticosteroid injections for the treatment of degenerative zygapophysial joint pain, or intradiscal corticosteroid injections. CONCLUSIONS The prospective, double-blind, randomized placebo-controlled trials in the interventional spine literature demonstrate efficacy from several different procedures when properly performed on appropriate patients. Other procedures have been shown to lack efficacy, while inconclusive evidence exists from multiple other interventional spine procedures. Further details are discussed in the text.

Epidural Steroid Injections are Safe and Effective: Multisociety Letter in Support of the Safety and Effectiveness of Epidural Steroid Injections

BACKGROUND In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. RESULTS The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multisociety support for the safety and effectiveness of these procedures. A special note of thanks to all of the societies who signed on in support of the message.

Are All Epidurals Created Equally? A Systematic Review of the Literature on Caudal, Interlaminar, and Transforaminal Injections from the Last 5 Years

Abstract Spinal pathology is a common source of pain. Epidural injections are frequently utilized to treat spine-based pain. There are several routes of epidural injection including the caudal, interlaminar, and transforaminal approaches. The final needle position for these various routes of injection varies significantly, even when the same underlying pathology is targeted. This has lead to vigorous debate regarding the ideal approach for these common procedures. The goal of this article is to discuss the recent literature regarding the outcomes of the various epidural routes in the lumbar spine.

The Importance of Image Guidance during Epidural Injections: Rates of Incorrect Needle Placement during Non-Image Guided Epidural Injections

Background: Epidural steroid injections are commonly-performed procedures used to treat several spinal conditions. Traditionally, these procedures have been performed without image guidance. However, a large number of blindly-performed injections are inaccurate with needle placement outside the epidural space. The purpose of the current article was to review the data on inaccuracy rates of non-image guided epidural injections. Results and Conclusions: 9-52% of non-image guided caudal epidural injections are outside the epidural space. 7-30% on non-image guided lumbar interlaminar epidural injections is outside the epidural space.

Re: Manchikanti L, Singh V, Falco FJ, et al. Cervical medial branch blocks for chronic cervical facet joint pain: a randomized, double-blind, controlled trial with one-year follow-up. Spine 2008;33:1813-20.

Re: Manchikanti L, Singh V, Falco FJ, et al. Cervical medial branch blocks for chronic cervical facet joint pain: a randomized, double-blind, controlled trial with one-year follow-up. Spine 2008;33:1813–20. We read with interest the study by Manchikanti et al. Although the abstract left the impression of a novel and promising treatment for neck pain, the manuscript gave us the sense of being led down 1 path when the data pointed toward another. Interestingly, all of the research into the potential therapeutic value of medial branch blocks (MBB) comes from a single center, with the only exception showing MBB are less effective than intraarticular injections. When a new treatment paradigm is conceived—in this case therapeutic use of MBB—2 duties follow. The first is to explain concept validity. In this study, the established use of MBB as a short-lived diagnostic test to select patients for medial branch, radiofrequency neurotomy has somehow morphed into a therapeutic endeavor with unexplained lasting benefits. What is the rational for this? Long-term benefit from radiofrequency neurotomy is a reasonable expectation. Although evidence is limited regarding intraarticular corticosteroid injections, a solid rationale exists to expect long-term benefits. Therapeutic injections adjacent to nerves under pathologic conditions, such as radiculopathy from disc herniation or carpal tunnel syndrome, are well established. However, there is no known pathology of the medial branch nerves that leads to cervical facet joint pain. Theories of sensitization of pain pathways remind us of other complex reasoning strategies to explain simple problems and do not alter our logical skepticism. Given the lack of a proven clinical basis, the second duty becomes even more important, to demonstrate efficacy of this new treatment. Such proof is typically provided in a double-blinded randomized placebo-controlled trial (DBRPCT). The authors justify the current study by explaining it to be a pragmatic clinical trial (PCT). Although the authors correctly describe the differences between DBRPCTs to determine efficacy and PCTs to demonstrate effectiveness, they overlook the key underlying principles of PCTs. Specifically, PCTs are intended to compare accepted treatment alternatives in a variety of practice settings, collecting data from a broad range of health outcomes. In this study, none of the treatment groups comprise a generally accepted treatment for chronic neck pain, the patients are from a single clinic, and the outcome measures are limited. Thus, we cannot help wondering whether the original intent of the study designers was to determine efficacy of therapeutic MBB with a DBRPCT. This makes sense because the study design contains several hallmark features of a DBRPCT. The outcome measures are concise and validated, and the treatment groups are perfectly designed to test the efficacy of corticosteroid and/or Sarapin (High Chemical Co., Levittown, PA) against a commonly used placebo-bupivacaine. The authors of this study conclude that MBB in all forms (with or without corticosteroids and/or Sarapin) are equally effective treatments for chronic neck pain. We choose to follow a more logical path. As a DBRPCT, this study produced negative findings and determined that therapeutic MBB are no better than placebo. Thus, a study of their effectiveness is unnecessary.

Radiculopathy from herniation of the nucleus pulposus: 2. The role of corticosteroids

The role of corticosteroids in the treatment of radiculopathy from a disc herniation is to provide temporary improvement of the disabling symptoms while the condition resolves. In addition, corticosteroids provide neuroprotective effects on the involved nerve roots. Early studies of corticosteroids for radiculopathy contained multiple methodological flaws and failed to demonstrate consistent results. Since each of these studies used inaccurate and less effective injection techniques, their results do not apply to current practice. More recent studies with better designs and more precise injection techniques have shown epidural corticosteroid injections to be an effective treatment for radiculopathy from herniated nucleus pulposus. The literature on systemic corticosteroids remains limited.

The Value of Electrodiagnostic Studies in Predicting Treatment Outcomes for Patients with Spine Pathologies.

The utility of electrodiagnostic testing for spine pathologies varies based on the underlying suspected pathology. This article reviews the data on electrodiagnostic testing for common spine pathologies, with a specific focus on the prognostic data with regard to treatment outcomes. This information is placed into context of diagnostic confidence, which is derived from the combination of disease prevalence and the sensitivity and specificity of a test.

Poster 483: Immediate vs. Prolonged Pain Relief After Sacroiliac Joint Injection with Anesthetic and Corticosteroid: A Prospective Study

discharge. Among those with a reported psychosocial health related quality of life score, 135 had a score at baseline, 130 at admission, and 64 reported post-discharge. The cohort was between ages 4-21, primarily Caucasian, male, and English speaking. Patient and familyreported physical HRQOL improved significantly from the time of rehabilitation admission to outpatient follow-up (mean score 20.2 to 59.7, P<.001). Psychosocial HRQOL improved, though to a lesser extent (mean score 55.8 to 71.2, P<.001). Conclusions: Patient and family-reported physical and psychosocial HRQOL, which are impacted significantly by new functional impairment, are seen to improve significantly through a course of inpatient rehabilitation. Despite significant loss to follow-up, we were able to determine the magnitude of change was greater than the 10-point decrement previously clinically correlated with an increase in 30-day readmissions and emergency department return visits. Inpatient rehabilitation is associated with important benefits for perceived HRQOL. Level of Evidence: Level III

Poster 463: The Effect of Patient Satisfaction Surveys on Physician Practice Patterns

Main Outcome Measures: Muscle tone (AS) in upper and lower extremities, Functional Independence Measure (FIM), pain, and safety were assessed after 6 months of treatment. Results: Mean (SD) AS in the affected lower limbs decreased by 0.99 (0.75) in the ITB group compared to 0.43 (0.72) in the CMM patients (P<.05). Decrease of AS in upper extremities was 0.66 (0.59) versus 0.17 (0.70) in ITB and CMM groups, respectively (P<.05). FIM improved in the ITB group by 2.68 (10.31) compared to a worsening in CMM arm -2.58 (11.00) (P1⁄4.054). In addition, ITB patients reported reduction in actual, least and worst pain. Difference in the change from baseline to month 6 between ITB and CMM was statistically significant in least and actual pain (P<.05). Seven serious adverse drug reactions (SADR, constipation, fecal impaction, epilepsy, peripheral edema, hypotension, 2 urinary retention) and 4 serious device reactions (device dislocation, infection, catheter occlusion, intracranial hypotension) were observed in the implanted patients (24% and 16% of patients, respectively) versus 1 SADR (epilepsy) in the CMM group (3%). All serious events related to the device or drug were treated and resolved. Conclusions: This is the first RCT clinical evidence showing superior efficacy of ITB therapy compared to conventional oral medication in decreasing post-stroke spasticity. Level of Evidence: Level I

Poster 484: A Multi-Institutional Randomized, Double-Blind, Placebo-Controlled, Prospective Study of Intra-Articular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as Treatment of Chronic Low Back Pain in a Selected Population

Design: Prospective study on consecutive patients undergoing a fluoroscopically guided injection into the SIJ. Setting: Academic institution. Participants: Patients suspected given history and physical examination to have SIJ mediated pain. Interventions: 2 cc mixture of 1cc of 2% lidocaine and 1 cc of triamcinolone 40mg/mL was injected into the SIJ after correct needle placement was confirmed using contrast dye and real time fluoroscopy. Main Outcome Measures: An independent physician assessed pain score on 0-10 scale immediately before and after the injection, and at 2-4 weeks and 6 months after the injection. Results: 100% immediate pain relief was considered a positive anesthetic response, while 50% pain relief at follow-up was considered positive. 14/34 (41.0%, 95% CI 26.4-57.8%) obtained 100% immediate relief. 8/14 (57.1%, 95% CI 32.6-78.6%) that had 100% initial relief reported 50% relief at 2-4 weeks, and 5/8 (62.5%, 95% CI 30.6-86.3%) had 50% relief at 6 months. Of the 6/14 (42.9%, 95% CI 21.4-67.4%) that had an initial 100% pain relief, but did not achieve 50% pain relief at 2 weeks, 0/6 (0%, 95% CI 0-39.0%) had 50% pain relief at 6 months. Of those with a negative initial block, only 3/20 (15%, 95% CI 5.2-36.0%) had 50% pain relief at 2 weeks or 6 months. Conclusions: This study illustrates a high negative predictive value of the immediate response at predicting pain relief at 2-4 weeks, but a much stronger positive predictive value of pain at 2-4 weeks for predicting continued pain relief at 6 months. Level of Evidence: Level II