Janna Friedly

Increases in lumbosacral injections in the Medicare population: 1994 to 2001.

Study Design. Anecdotal reports and limited data suggest that the use of spinal injections is increasing, despite equivocal evidence about efficacy. Objective. We sought to evaluate trends in lumbosacral injection use for low back pain, including the specialties providing the injections and the costs of care. Summary of Background Data. The current literature reports success rates of 18% to 90% for lumbosacral steroid injections, depending on methodology, outcome measures, patient selection, and technique. Preliminary data suggest that spinal injection rates are rising, despite ambiguity in the literature regarding their clinical effectiveness. Methods. We used Medicare Physician Part B claims for 1994 through 2001 to examine the use of epidural steroid injections (ESI), facet joint injections, sacroiliac joint injections, and related fluoroscopy. Fee-for-service Medicare enrollees 65 years of age and older were included in this study. We used Current Procedural Technology (CPT) codes to identify the number of procedures performed each year, as well as trends in expenditures, physician specialties involved, and diagnoses assigned. Results. Between 1994 and 2001, there was a 271% increase in lumbar ESIs, from 553 of 100,000 to 2055 of 100,000 patients, and a 231% increase in facet injections from 80 of 100,000 to 264 of 100,000 patients. The total inflation-adjusted reimbursed costs (professional fees only) for lumbosacral injections increased from

Systemic Pharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline.

24 million to over

Geographic variation in epidural steroid injection use in medicare patients

175 million. Also, costs per injection doubled, from

Management Patterns in Acute Low Back Pain: the Role of Physical Therapy

115 to

Epidemiology of Spine Care: The Back Pain Dilemma

227 per injection. Forty percent of all ESIs were associated with diagnosis codes for sciatica, radiculopathy, or herniated disc, whereas axial low back pain diagnoses accounted for 36%, and spinal stenosis for 23%. Conclusion. Lumbosacral injections increased dramatically in the Medicare population from 1994 to 2001. Less than half were performed for sciatica or radiculopathy, where the greatest evidence of benefit is available. These findings suggest a lack of consensus regarding the indications for ESIs and are cause for concern given the large expenditures for these procedures.

Epidural Corticosteroid Injections for Radiculopathy and Spinal Stenosis: A Systematic Review and Meta-analysis

Low back pain is one of the most frequently encountered conditions in clinical practice (1, 2). The most commonly prescribed medications for low back pain are nonsteroidal anti-inflammatory drugs (NSAIDs), skeletal muscle relaxants, antidepressants, and opioids (35); benzodiazepines, systemic corticosteroids, and antiseizure medications are also prescribed (3). Patients often use over-the-counter acetaminophen and NSAIDs. A 2007 guideline (6) and associated systematic review (7) from the American College of Physicians (ACP) and American Pain Society (APS) found evidence to support the use of acetaminophen and NSAIDs as first-line pharmacologic options for low back pain; secondary options were skeletal muscle relaxants, benzodiazepines, and antidepressants. New evidence and medications are now available. Here, we review the current evidence on benefits and harms of medications for low back pain. This article has been used by ACP to update a clinical practice guideline, also in this issue. Methods Detailed methods and data for our review, including the analytic framework, additional medications (topical capsaicin and lidocaine), nonpharmacologic therapies (addressed in a separate article) (8), search strategies, inclusion criteria, data extraction and quality-rating methods, and additional outcomes (for example, quality of life, global improvement, and patient satisfaction), are available in the full report (9). The protocol was developed by using a standardized process (10) with input from experts and the public and is registered in the PROSPERO database (11). This article addresses the key question, what are the comparative benefits and harms of different systemic pharmacologic therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? Data Sources and Searches A research librarian searched Ovid MEDLINE (January 2007 through April 2015), the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews (through April 2015). We used the prior ACP/APS review (12) to identify earlier studies. Updated searches were performed through November 2016. We also reviewed reference lists and searched ClinicalTrials.gov. Study Selection Two investigators independently reviewed abstracts and full-text articles against prespecified eligibility criteria. The population was adults with nonradicular or radicular low back pain of any duration (categorized as acute [<4 weeks], subacute [4 to 12 weeks], and chronic [12 weeks]). Excluded conditions were low back pain due to cancer, infection, inflammatory arthropathy, high-velocity trauma, or fracture; low back pain during pregnancy; and presence of severe or progressive neurologic deficits. We evaluated acetaminophen, NSAIDs, opioids, tramadol and tapentadol, antidepressants, skeletal muscle relaxants, benzodiazepines, corticosteroids, and antiseizure medications versus placebo, no treatment, or other therapies. We also evaluated the combination of 2 medications versus 1 medication alone. Outcomes were long-term (1 year) or short-term (6 months) pain or function, mood (for antidepressants), risk for surgery (for corticosteroids), and harms. Given the large number of medications addressed, we included systematic reviews of randomized trials (13, 14). For each medication, we selected the most recent, most relevant, and highest-quality comprehensive systematic review based on a validated assessment tool (14, 15). If more than 1 good-quality systematic review was available, we preferentially selected updates of those used in the ACP/APS review. We supplemented systematic reviews with additional trials. Although we did not include systematic reviews identified in update searches, we checked reference lists for additional studies. We excluded nonEnglish-language articles and abstract-only publications. Data Extraction and Quality Assessment One investigator extracted study data, and a second verified accuracy. For systematic reviews, we abstracted details about inclusion criteria, search strategy, databases searched, search dates, number and characteristics of included studies, quality assessment methods and ratings, synthesis methods, and results. For randomized trials, we abstracted details about the setting, sample size, eligibility criteria, population characteristics, treatment characteristics, results, and funding source. Two investigators independently assessed the quality of each study as good, fair, or poor using criteria developed by the U.S. Preventive Services Task Force (for randomized trials) (16) and AMSTAR (A Measurement Tool to Assess Systematic Reviews) (14). For primary studies included in systematic reviews, we used both the quality ratings and the overall grade (for example, good, fair, or poor, or high or low) as determined in the reviews. We classified the magnitude of effects as small/slight, moderate, or large/substantial based on the definitions in the ACP/APS review (Table 1) (6, 17). We also reported risk estimates based on the proportion of patients achieving successful pain or function outcomes (for example, >30% or >50% improvement). Table 1. Definitions for Magnitude of Effects, Based on Mean Between-Group Differences Data Synthesis and Analysis We synthesized data qualitatively for each medication, stratified according to the duration of symptoms (acute, subacute, or chronic) and presence or absence of radicular symptoms. We reported meta-analysis results from systematic reviews. When statistical heterogeneity was present, we examined the degree of inconsistency and evaluated subgroup and sensitivity analyses. We did not conduct an updated meta-analysis; rather, we qualitatively examined whether results of new studies were consistent with pooled or qualitative findings from prior systematic reviews. Qualitative assessments were based on whether the findings from the new studies were in the same direction as the prior systematic reviews and whether the magnitude of effects was similar; when prior meta-analyses were available, we analyzed whether the estimates and CIs from new studies were encompassed in the CIs from pooled estimates. We assessed the strength of evidence (SOE) for each body of evidence as high, moderate, low, or insufficient based on aggregate study quality, precision, consistency, and directness (18). Role of the Funding Source The Agency for Healthcare Research and Quality (AHRQ) of the U.S. Department of Health and Human Services funded this review. AHRQ staff assisted in developing the scope and key questions. The AHRQ had no role in study selection, quality assessment, or synthesis. Results Literature Search The search and selection of articles are summarized in the Figure. Database searches found 2847 potentially relevant articles. After dual review of abstracts and titles, we selected 746 articles for full-text dual review; 46 publications met inclusion criteria. Quality ratings are summarized in Supplement Tables 1 and 2. Supplement. Data Supplement. Figure. Summary of evidence search and selection. ACP = American College of Physicians; AHRQ = Agency for Healthcare Research and Quality; APS = American Pain Society; NSAID = nonsteroidal anti-inflammatory drug; RCT = randomized, controlled trial; SR = systematic review. * Cochrane databases include the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews. Other sources include prior reports, reference lists of relevant articles, and systematic reviews. Publications may be included or excluded for multiple reasons. Acetaminophen Ten trials evaluated acetaminophen; 9 of these (sample sizes, 39 to 456) were included in the ACP/APS review (19). We identified 1 additional large (n= 1643), good-quality, placebo-controlled trial (20). Six trials compared acetaminophen with NSAIDs and were included in a systematic review of NSAIDs (Supplement Table 3) (21, 22). Along with the new trial, 3 others (2325) were rated good- or high-quality. For acute low back pain, 1 new trial found no differences between 4 weeks or less of scheduled or as-needed acetaminophen (about 4 g/d) and placebo in pain (differences, 0.20 point on a 0- to 10-point scale), function (differences, 0.60 point on the 0- to 24-point RolandMorris Disability Questionnaire [RDQ]), or risk for serious adverse events (about 1% in each group) after 12 weeks (Supplement Table 4) (20). One trial of acetaminophen versus no treatment included in the ACP/APS review (26) also found no differences. We found no difference between acetaminophen and NSAIDs in pain intensity (standardized mean difference [SMD], 0.21 [95% CI, 0.02 to 0.43]) at 3 weeks or less based on 3 low-quality trials, although estimates favored NSAIDs (22). Acetaminophen had a lower risk for adverse events than NSAIDs (relative risk [RR], 0.57 [CI, 0.36 to 0.89]). Evidence was insufficient to determine the effects of acetaminophen versus various nonpharmacologic therapies (24, 27, 28) or amitriptyline (25); each comparison was evaluated in 1 trial with methodological shortcomings. No study evaluated acetaminophen for chronic or radicular low back pain. NSAIDs Seventy trials evaluated NSAIDs; 57 were in the ACP/APS review. Sixty-five trials (total n= 11237; sample sizes, 20 to 690), 28 of which were high-quality, were included in a systematic review (Supplement Table 3) (22). We identified 5 additional trials (n= 54 to 525) (Supplement Table 5) (2933). One trial was rated good-quality (31), and 4 were rated fair-quality (29, 30). For acute back pain, 1 systematic review (22) found that NSAIDs were associated with greater mean improvements in pain intensity than placebo (4 trials: weighted mean difference, 8.39 points on a 0- to 100-point scale [CI, 12.68 to 4.10 points]; chi-square test, 3.47 points; P> 0.10) (3437). One additional trial (n= 171) reported consistent findings (29). Three trials in this review found no differences between an NSAID and placeb

Association of Early Imaging for Back Pain With Clinical Outcomes in Older Adults

BACKGROUND The rates of epidural steroid injections have increased dramatically over time, with conflicting evidence regarding the efficacy of epidural steroid injections for the treatment of various low-back pain disorders. Given the uncertainty about their role, we sought to evaluate the geographic variation in the use of epidural steroid injections for low back pain within the United States. We also sought to determine whether greater rates of epidural steroid injections are associated with lower rates of lumbar surgery. METHODS We used the 2001 Medicare Physician Part-B claims to examine the geographic variation in the use of epidural steroid injections. Current Procedural Technology codes were used to identify the number of procedures performed as well as the percentage of injections that were fluoroscopically guided. Procedure rates were analyzed with use of several geographic indicators, including state, United States Census Bureau regions (Northeast, South, Midwest, and West), and health referral regions as defined by the Dartmouth Atlas of Health Care. RESULTS In 2001, there was a 7.7-fold difference between the state with the lowest rate (Hawaii at 5.2 per 1000) and the state with the highest rate (Alabama at 39.9 per 1000). The variation among health referral regions, which are smaller in size, was even greater, with an 18.4-fold difference from 5.6 per 1000 in Honolulu, Hawaii, to 103.6 per 1000 in Palm Springs, California. Higher statewide rates of epidural steroid injections were associated with significantly higher rates of lumbar surgery (p = 0.001). In areas with high injection rates, a significantly higher percentage of patients who sought care for low back pain received injections (p < 0.001). In addition, in areas with high injection rates, a significantly higher percentage of patients who presented with low back pain received both injections and lumbar surgery within the same year (p < 0.001). CONCLUSIONS There is substantial geographic variation in the rates of epidural steroid injections within the United States. Southern states tend to have the highest procedure rates, whereas northeastern states have the lowest. Injection rates are positively correlated with lumbar surgery rates; therefore, epidural steroid injections do not appear to be substituting for lumbar surgeries or reducing overall rates of lumbar surgery.

Comparative effectiveness of exercise, acupuncture, and spinal manipulation for low back pain

Study Design. Retrospective cohort study. Objective. To evaluate the relationship between early physical therapy (PT) for acute low back pain and subsequent use of lumbosacral injections, lumbar surgery, and frequent physician office visits for low back pain. Summary of Background Data. Wide practice variations exist in the treatment of acute low back pain. PT has been advocated as an effective treatment in this setting although disagreement exists regarding its purported benefits. Methods. A national 20% sample of the Centers for Medicare and Medicaid Services physician outpatient billing claims was analyzed. Patients were selected who received treatment for low back pain between 2003 and 2004 (n = 439,195). To exclude chronic low back conditions, patients were excluded if they had a prior visit for back pain, lumbosacral injection, or lumbar surgery within the previous year. Main outcome measures were rates of lumbar surgery, lumbosacral injections, and frequent physician office visits for low back pain during the following year. Results. Based on logistic regression analysis, the adjusted odds ratio for undergoing surgery in the group of enrollees that received PT in the acute phase (<4 weeks) compared to those receiving PT in the chronic phase (>3 months) was 0.38 (95% confidence interval [CI], 0.360.41), adjusting for age, sex, diagnosis, treating physician specialty, and comorbidity. The adjusted odds ratio for receiving a lumbosacral injection in the group receiving PT in the acute phase was 0.46 (95% CI, 0.44–0.49), and the adjusted odds ratio for frequent physician office usage in the group receiving PT in the acute phase was 0.47 (95% CI, 0.44–0.50). Conclusion. There was a lower risk of subsequent medical service usage among patients who received PT early after an episode of acute low back pain relative to those who received PT at later times. Medical specialty variations exist regarding early use of PT, with potential underutilization among generalist specialties.

Does Targeted Nerve Implantation Reduce Neuroma Pain in Amputees

In this article, the epidemiology of back pain and the use of a variety of treatments for back pain in the United States are reviewed. The dilemma faced by medical providers caring for patients with low back pain is examined in the context of epidemiologic data. Back pain is becoming increasingly common and a growing number of treatment options are being used with increasing frequency in clinical practice. However, limited evidence exists to demonstrate the effectiveness of these treatments. In addition, health-related quality of life for persons with back pain is not improving despite the availability and use of an expanding array of treatments. This dilemma poses a difficult challenge for medical providers treating individual patients who suffer from back pain.

The relationship between repeated epidural steroid injections and subsequent opioid use and lumbar surgery.

Low back pain is one of the most frequently encountered conditions in clinical practice (15). Although most low back pain is nonradicular, symptomatic spinal stenosis or herniated disc each occur in about 3% to 4% of patients (6). Epidural corticosteroid injections are most commonly performed for radiculopathy due to a herniated disc, but may also be given for spinal stenosis. Despite conflicting conclusions from systematic reviews (713) and discordant clinical practice guidelines (1417), use of epidural injections has increased (18, 19). Challenges in interpreting the evidence on epidural corticosteroid injections include variability in the methods used to select patients for inclusion, the injection techniques used, choice of comparators, and when and how outcomes are assessed (10, 20). The purpose of this systematic review is to synthesize the current evidence on the effects of epidural corticosteroid injections for radiculopathy and spinal stenosis. Methods Detailed methods and data for this review, including the analytic framework, key questions, search strategies, inclusion criteria, study data extraction, and quality ratings, are available in the full report (21). The full report also addresses other types of injections, nonradicular and postsurgical back pain, and effects of epidural injections versus active comparators. The protocol was developed by using a standardized process (22) with input from experts and the public, and was posted on the Agency for Healthcare Research and Quality (AHRQ) Web site on 29 May 2014 (23). This article focuses on the effectiveness and harms of epidural corticosteroid injections for radiculopathy or spinal stenosis, and whether effectiveness estimates vary according to technical factors, patient characteristics, or type of placebo comparator. We defined placebo interventions as epidural saline or local anesthetic injections without corticosteroid, a soft-tissue injection, or no injection, on the basis of the assumption that therapeutic effects in the epidural space are primarily related to the corticosteroid. Technical factors included the corticosteroid or local anesthetic used, medication doses, volume of injectate, number of levels injected, frequency and number of injections, use of imaging guidance, and route of administration. Patient characteristics included demographic (for example, age, sex, race) and clinical factors (for example, imaging findings, duration of symptoms, and presence of psychosocial factors or neurologic findings). Data Sources and Searches A research librarian searched MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews from 2008 through May 2015. Studies published before 2008 were identified from prior reviews that we conducted (7, 24). We also reviewed reference lists and searched ClinicalTrials.gov. Study Selection Two investigators independently reviewed abstracts and full-text articles against prespecified eligibility criteria. We included randomized trials of adults undergoing epidural corticosteroid injections versus placebo interventions for radicular low back pain or spinal stenosis of any duration. We considered sciatica to be synonymous with radiculopathy. We included epidural injections performed via any approach, as well as transforaminal injections that did not necessarily enter the epidural space (periradicular injections). We also included studies that directly compared injection techniques, corticosteroids, and corticosteroid doses. Outcomes were pain, function, composite outcomes, subsequent surgery measured at least 5 days after the injection, and local and systemic harms. For harms, we also included large treatment series (sample size >1000 patients). We excluded studies of back pain due to fracture, high-impact trauma, cancer, or infection. Data Extraction and Quality Assessment One investigator extracted details about the study design, patient sample, setting, interventions, and results. Another investigator verified extractions for accuracy. Two investigators independently assessed risk of bias (quality) for each randomized trial as good, fair, or poor by using predefined criteria (25). Discrepancies were resolved through a consensus process. Data Synthesis and Analysis We conducted meta-analyses by using the DersimonianLaird random-effects method in Stata/IC 13.0 (StataCorp LP). Statistical heterogeneity was measured with the Cochran chi-square test and the I 2 statistic (26). When statistical heterogeneity was present, we repeated meta-analysis by using the profile likelihood method (27). All analyses were stratified by the approach used (transforaminal, interlaminar, or caudal). Outcomes were analyzed as immediate (5 days to 2 weeks), short-term (2 weeks to 3 months), intermediate-term (3 months to <1 year), and long-term (>1 year), using the longest-duration data available within each category. For continuous outcomes, pain scores were converted to a scale of 0 to 100 and pooled as weighted mean differences (WMDs); function was pooled as standardized mean differences (SMDs) unless all trials in an analysis reported the same functional outcome. We used pain scores for leg pain when available, and overall or back pain when leg pain was not reported. The mean difference was calculated from the change from baseline to follow-up; sensitivity analysis based on adjusted estimates (for example, analysis of covariance) or differences in follow-up scores gave similar results and are not reported further. We imputed missing SDs by using the mean value from other studies in that analysis. For dichotomous outcomes, we pooled relative risks (RRs) for successful (as defined in the trials) pain, function, and composite outcomes and rates of subsequent surgery. To investigate whether certain placebo interventions might have therapeutic effects, we also performed separate pooled analyses on the placebo group response rates for continuous and dichotomous outcomes, stratified by the specific type of placebo comparator. We performed sensitivity analyses excluding poor-quality and outlier studies, and subgroup analyses and meta-regression on the corticosteroid, corticosteroid dose (in prednisolone equivalents), the local anesthetic, the comparator, injectate volume, symptom duration, use of imaging correlation, use of fluoroscopic guidance, number of injections, exclusion of patients with prior surgery, year of publication, and blinding methods. For analyses with at least 10 studies, we created funnel plots and performed the Egger test for small sample effects (28). We defined a minimum clinically important difference as an improvement in 15 points on a pain scale of 0 to 100, 10 points on the Oswestry Low Back Pain Disability Index (ODI), and 5 points on the RolandMorris Disability Questionnaire (RDQ) (29). We assessed the overall strength of each body of evidence as high, moderate, low, or insufficient on the basis of aggregate study quality, precision, consistency, and directness (22). Role of the Funding Source The AHRQ funded the review at the request of the Centers for Medicare & Medicaid Services, who assisted in developing the scope of the review and key questions. Neither organization had a role in study selection, quality assessment, or synthesis. The investigators are solely responsible for the content. Results The literature search and selection is summarized in the Appendix Figure. Database searches resulted in 202 potentially relevant articles. After full-text dual review, 59 trials and 4 observational studies met inclusion criteria for the interventions and comparisons addressed in this article. Appendix Figure. Summary of evidence search and selection. * Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews. Reference lists of relevant articles and systematic reviews, among other sources. The full report (21) also addresses other types of injections, nonradicular and postsurgical back pain, and effects of epidural injections versus active comparators. Some studies are included for more than 1 question. Thirty trials (26 to 239 participants) compared epidural corticosteroid injections via various approaches with placebo interventions for radiculopathy (3058), and 8 trials (29 to 386 participants) compared epidural corticosteroid injections with placebo interventions for spinal stenosis (Appendix Table 1) (37, 40, 5964). Duration of follow-up ranged from 1 week to 3 years. The trials primarily evaluated patients with chronic symptoms. Appendix Table 1. Trials of Epidural Corticosteroid Injections for Radicular Pain and Spinal Stenosis Appendix Table 1.Continued Appendix Table 1.Continued Four trials of epidural injections for radiculopathy (60 to 106 participants) (6568) and 1 trial of spinal stenosis (70 participants) (69) evaluated effects of one corticosteroid versus another, and 6 trials (33 to 60 participants) evaluated corticosteroid dose effects (7075). Eleven trials (30 to 239 participants) directly compared alternative epidural injection techniques (46, 7685). Two trials compared effects of different patient evaluation and selection methods involving imaging (86, 87). Five trials were rated as good-quality (36, 43, 44, 59, 84), 40 trials as fair-quality, and 14 trials as poor-quality. Methodological shortcomings included failure to report adequate randomization or allocation concealment methods; inadequate blinding of outcome assessors, injectionists, or patients; high or unclearly reported attrition; and failure to specify primary outcomes. Effectiveness Radiculopathy Epidural corticosteroid injections were associated with greater immediate reduction in pain intensity compared with placebo interventions (6 trials; WMD on a scale of 0 to 100, 7.55 [95% CI, 11.4 to 3.74]; I 2= 30%; strength of evidence [SOE], moderate) (33, 38, 41, 44, 45, 57) (Figure 1 of the Supplement, but differences were smaller and not statistical