Multicenter, Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine for Mechanical Cervical Pain.

BACKGROUND: There are few efficacious treatments for mechanical neck pain, with controlled trials suggesting efficacy for muscle relaxants and topical nonsteroidal anti-inflammatory drugs. Although studies evaluating topical lidocaine for back pain have been disappointing, the more superficial location of the cervical musculature suggests a possible role for topical local anesthetics. METHODS: This study was a randomized, double-blind, placebo-controlled crossover trial performed at four U.S. military, Veterans Administration, academic, and private practice sites, in which 76 patients were randomized to receive either placebo followed by lidocaine patch for 4-week intervals (group 1) or a lidocaine-then-placebo patch sequence. The primary outcome measure was mean reduction in average neck pain, with a positive categorical outcome designated as a reduction of at least 2 points in average neck pain coupled with at least a 5-point score of 7 points on the Patient Global Impression of Change scale at the 4-week endpoint. RESULTS: For the primary outcome, the median reduction in average neck pain score was -1.0 (interquartile range, -2.0, 0.0) for the lidocaine phase versus -0.5 (interquartile range, -2.0, 0.0) for placebo treatment (P = 0.17). During lidocaine treatment, 27.7% of patients experienced a positive outcome versus 14.9% during the placebo phase (P = 0.073). There were no significant differences between treatments for secondary outcomes, although a carryover effect on pain pressure threshold was observed for the lidocaine phase (P = 0.015). A total of 27.5% of patients in the lidocaine group and 20.5% in the placebo group experienced minor reactions, the most common of which was pruritis (P = 0.36). CONCLUSIONS: The differences favoring lidocaine were small and nonsignificant, but the trend toward superiority of lidocaine suggests more aggressive phenotyping and applying formulations with greater penetrance may provide clinically meaningful benefit.

Effectiveness of Lumbar Facet Joint Blocks and Predictive Value before Radiofrequency Denervation: The Facet Treatment Study (FACTS), a Randomized, Controlled Clinical Trial.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: With facet interventions under scrutiny, the authors' objectives were to determine the effectiveness of different lumbar facet blocks and their ability to predict radiofrequency ablation outcomes. METHODS: A total of 229 participants were randomized in a 2:2:1 ratio to receive intraarticular facet injections with bupivacaine and steroid, medial branch blocks, or saline. Those with a positive 1-month outcome (a 2-point or more reduction in average pain score) and score higher than 3 (positive satisfaction) on a 5-point satisfaction scale were followed up to 6 months. Participants in the intraarticular and medial branch block groups with a positive diagnostic block (50% or more relief) who experienced a negative outcome proceeded to the second phase and underwent radiofrequency ablation, while all saline group individuals underwent ablation. Coprimary outcome measures were average reduction in numerical rating scale pain score 1 month after the facet or saline blocks, and average numerical rating scale pain score 3 months after ablation. RESULTS: Mean reduction in average numerical rating scale pain score at 1 month was 0.7 ± 1.6 in the intraarticular group, 0.7 ± 1.8 in the medial branch block group, and 0.7 ± 1.5 in the placebo group; P = 0.993. The proportions of positive blocks were higher in the intraarticular (54%) and medial branch (55%) groups than in the placebo group (30%; P = 0.01). Radiofrequency ablation was performed on 135 patients (45, 48, and 42 patients from the intraarticular, medial branch, and saline groups, respectively). The average numerical rating scale pain score at 3 months was 3.0 ± 2.0 in the intraarticular, 3.2 ± 2.5 in the medial branch, and 3.5 ± 1.9 in the control group (P = 0.493). At 3 months, the proportions of positive responders in the intraarticular, medial branch block, and placebo groups were 51%, 56%, and 24% for the intraarticular, medial branch, and placebo groups, respectively (P = 0.005). CONCLUSIONS: This study establishes that facet blocks are not therapeutic. The higher responder rates in the treatment groups suggest a hypothesis that facet blocks might provide prognostic value before radiofrequency ablation.

Medial Branch Blocks or Intra-Articular Injections as a Prognostic Tool Before Lumbar Facet Radiofrequency Denervation: A Multicenter, Case-Control Study.

BACKGROUND: Medial branch blocks (MBBs) and intra-articular (IA) facet joint injections are both used to diagnose facet joint pain and are presumed to be equivalent. No study has sought to determine which has a better prognostic value before radiofrequency (RF) denervation. METHODS: A case-control study was performed at 4 institutions in which RF denervation outcomes in patients who obtained 50% or more pain relief from either MBB (n = 212) or IA injections (n = 212) were compared. "Control" patients (MBB) were matched to "cases" by treating physician, last name, and date of treatments. During data mining, 87 patients were identified who underwent RF ablation after receiving both IA injections and MBB and were used for secondary analyses. RESULTS: A total of 70.3% of MBB patients experienced 50% or more pain relief at the 3-month follow-up versus 60.8% in those who underwent IA injections (P = 0.041). In multivariable analysis, undergoing MBB was associated with RF treatment success (odds ratio [OR], 1.57; 95% confidence interval [95% CI], 1.0-2.39; P = 0.036), whereas opioid use (OR, 0.52; 95% CI, 0.34-0.79; P = 0.002) and previous back surgery (OR, 0.60; 95% CI, 0.38-0.95; P = 0.028) were associated with treatment failure. No significant differences were noted between MBB alone and combination treatment or single versus multiple blocks. In the secondary multivariable analysis including the combination IA + MBB group, MBB alone was again independently associated with an RF ablation treatment success (OR, 1.73; 95% CI, 1.12-2.67; P = 0.014). CONCLUSIONS: When used as a prognostic tool before lumbar facet radiofrequency, MBB may be associated with a higher success rate than IA injections. Our results should be confirmed by large, prospective, randomized studies.

Epidural steroids, etanercept, or saline in subacute sciatica: a multicenter, randomized trial.

BACKGROUND: Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy. OBJECTIVE: To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy. DESIGN: A multicenter, 3-group, randomized, placebo-controlled trial conducted from 2008 to 2011. Randomization was computer-generated and stratified by site. Pharmacists prepared the syringes. Patients, treating physicians, and nurses assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00733096) SETTING: Military and civilian treatment centers. PATIENTS: 84 adults with lumbosacral radiculopathy of less than 6 months' duration. INTERVENTION: 2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks. MEASUREMENTS: The primary outcome measure was leg pain 1 month after the second injection. All patients had 1-month follow-up visits; patients whose condition improved remained blinded for the 6-month study period. RESULTS: The group that received epidural steroids had greater reductions in the primary outcome measure than those who received saline (mean difference, -1.26 [95% CI, -2.79 to 0.27]; P = 0.11) or etanercept (mean difference, -1.01 [CI, -2.60 to 0.58]; P = 0.21). For back pain, smaller differences favoring steroids compared with saline (mean difference, -0.52 [CI, -1.85 to 0.81]; P = 0.44) and etanercept (mean difference, -0.92 [CI,-2.28 to 0.44]; P = 0.18) were observed. The largest differences were noted for functional capacity, in which etanercept fared worse than the other treatments: steroids vs. etanercept (mean difference, -16.16 [CI, -26.05 to -6.27]; P = 0.002), steroids vs. saline (mean difference, -5.87 [CI, -15.59 to 3.85]; P = 0.23), and etanercept vs. saline (mean difference, 10.29 [CI, 0.55 to 20.04]; P = 0.04). More patients treated with epidural steroids (75%) reported 50% or greater leg pain relief and a positive global perceived effect at 1 month than those who received saline (50%) or etanercept (42%) (P = 0.09). LIMITATION: Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept. CONCLUSION: Epidural steroid injections may provide modest short-term pain relief for some adults with lumbosacral radiculopathy, but larger studies with longer follow-up are needed to confirm their benefits. PRIMARY FUNDING SOURCE: The John P. Murtha Neuroscience and Pain Institute, International Spinal Intervention Society, and Center for Rehabilitation Sciences Research.

Multicenter, randomized, comparative cost-effectiveness study comparing 0, 1, and 2 diagnostic medial branch (facet joint nerve) block treatment paradigms before lumbar facet radiofrequency denervation.

BACKGROUND: Among patients presenting with axial low back pain, facet arthropathy accounts for approximately 10-15% of cases. Facet interventions are the second most frequently performed procedures in pain clinics across the United States. Currently, there are no uniformly accepted criteria regarding how best to select patients for radiofrequency denervation. METHODS: A randomized, multicenter study was performed in 151 subjects with suspected lumbar facetogenic pain comparing three treatment paradigms. Group 0 received radiofrequency denervation based solely on clinical findings; group 1 underwent denervation contingent on a positive response to a single diagnostic block; and group 2 proceeded to denervation only if they obtained a positive response to comparative blocks done with lidocaine and bupivacaine. A positive outcome was predesignated as > or =50% pain relief coupled with a positive global perceived effect persisting for 3 months. RESULTS: In group 0, 17 patients (33%) obtained a successful outcome at 3 months versus eight patients (16%) in group 1 and 11 (22%) patients in group 2. Denervation success rates in groups 0, 1, and 2 were 33, 39, and 64%, respectively. Pain scores and functional capacity were significantly lower at 3 months but not at 1 month in group 2 subjects who proceeded to denervation compared with patients in groups 0 and 1. The costs per successful treatment in groups 0, 1, and 2 were $6,286, $17,142, and $15,241, respectively. CONCLUSIONS: Using current reimbursement scales, these findings suggest that proceeding to radiofrequency denervation without a diagnostic block is the most cost-effective treatment paradigm.

Incidence and root cause analysis of wrong-site pain management procedures: a multicenter study.

BACKGROUND: Medical errors exact an inordinate toll on healthcare costs. One of the most publicized and analyzed type of medical error is wrong-site surgery. Yet, despite the burgeoning number of procedures performed, no literature exists on wrong-site pain management injections. The purpose of this study was to estimate the relative incidence and determine the causes of wrong-site pain management procedures. METHODS: Quality improvement records were examined during a 2-yr period from four civilian academic teaching hospitals, three military treatment facilities, and three private practices, for "sentinel" events involving wrong-site pain management procedures. A total of 13 cases (incidence 0.027%; 95% CI 0.01-0.05%) were identified from approximately 48,941 collective procedures of which 52.4% were deemed to be "at risk" for the occurrence. Root cause analyses were then conducted to determine the origin of each error. RESULTS: The 13 cases included five wrong-side transforaminal epidural steroid injections, six other wrong-side injections, and two wrong-level minimally invasive surgical procedures. In only one case was the "universal protocol" completely followed, and in nine procedures, multiple lapses occurred in protocol. Three patients had bilateral pathology, and in seven cases, the patient knew at the time that the wrong side was being injected. In no instance did any technical, legal, or professional consequences ensue from the error. CONCLUSIONS: Wrong-site nerve blocks occur more frequently in pain management centers than has previously been acknowledged. Adaptation of the universal protocol to nerve blocks and strict adherence to widely accepted guidelines may prevent wrong-site interventional pain procedures.

Acute renal failure during a trial of spinal cord stimulation: theories as to a possible connection.

OBJECTIVE: This is the first case describing an episode of acute renal failure occurring during a spinal cord stimulation trial. CLINICAL PRESENTATION: A 48-year-old male with a history of hypertension and 3 prior failed spine surgeries underwent a trial of spinal cord stimulation for uncontrolled bilateral lower extremity neuropathic pain. Two days after the placement of the percutaneous stimulator lead the patient returned complaining of 3 syncopal episodes. He was found to be hypotensive and in acute renal failure with a creatinine of 8.1 and a BUN of 83. INTERVENTION: The stimulator lead was immediately removed. The patient was admitted to the intensive care unit and responded promptly to rehydration and placement of a urinary catheter. His renal and urological work-ups revealed no significant abnormalities. CONCLUSION: The development of the episode of acute renal failure may have been influenced by the secondary effects of spinal cord stimulation. Since acute renal failure has never been associated with the use of spinal cord stimulation, this singular example does not by itself demonstrate a relationship. However, if future episodes are seen, a link between the 2 events could be drawn. For now, it is not clear if the development of this patient's acute renal failure could, in part, be attributed to the use of the spinal cord stimulator or if it was merely coincidental in nature. We do feel it is useful for the clinician to understand the pathophysiologic changes associated with spinal cord stimulation and to see how, at least in theory, there could be a connection.

Psychophysical measurements during lumbar discography: a heart rate response study.

STUDY DESIGN: Prospective clinical data analysis. OBJECTIVE: To determine if heart rate (HR) response correlates with positive discography results. SUMMARY OF BACKGROUND DATA: Lumbar discography is a controversial tool for the diagnosis of discogenic low back pain. The subjective nature of discography can make data interpretation difficult, leading to false-positive and false-negative results. HR changes have been found in numerous studies to be a reliable and valid indicator of acute pain. To date, there is no study analyzing the HR response to discography-induced pain. METHODS: The HR measurements were recorded immediately preceding and after contrast injection into the each disc, and statistically correlated with the provocation of concordant pain, nonconcordant pain, and nonpainful discs. RESULTS: Discography was performed in 26 subjects with low back pain. Among 75 discograms, 26 discs elicited concordant pain, 9 provoked nonconcordant pain, and 40 elicited no pain response. There was no significant change in HR during disc stimulation for negative [no pain response (P=0.19) and nonconcordant (P=0.26)] discograms, whereas positive discograms [concordant pain (numerical rating scale> or =6/10)] were associated with a statistically significant increase in HR (P=0.000002). CONCLUSIONS: Lumbar discography induces positive HR response only in positive discograms. Although there is no immediate practical application of these results, 2 implications may deserve future research: (a) correlation of HR response with surgical and intradiscal electrotherapy treatment outcomes; (b) evaluation of HR measurement in cases of false-positive results (concordant pain on discography but no HR response).

A double-blind, placebo-controlled, dose-response pilot study evaluating intradiscal etanercept in patients with chronic discogenic low back pain or lumbosacral radiculopathy.

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.

Pulsed radiofrequency of the dorsal root ganglia is superior to pharmacotherapy or pulsed radiofrequency of the intercostal nerves in the treatment of chronic postsurgical thoracic pain.

BACKGROUND: Chronic postsurgical thoracic pain (CPTP) represents a major therapeutic challenge characterized by an absence of clinical studies to guide treatment. Recently, the implementation of pulsed radiofrequency (RF) has generated intense interest in the medical community as a safe and potentially effective treatment for neuropathic pain. To date, there are no studies comparing pulsed RF to more conventional therapeutic modalities for any pain condition. OBJECTIVES: To compare treatment outcomes between pharmacotherapy, pulsed RF of the intercostal nerves (ICN) and pulsed RF of the dorsal root ganglia (DRG) in CPTP. METHODS: Retrospective data analysis involving 49 patients. RESULTS: At 6-week follow-up, 61.5% of the pulsed RF DRG group reported > or =50% pain relief vs. 27.3% in the medical management (MM) group and 21.4% in the IC group (P = 0.12). At 3-month follow-up, 53.8% in the DRG group continued to report > or = 50% pain relief vs. 19.9% in the MM and 6.7% in the ICN groups, respectively (P = 0.02). Among the pulsed RF patients who did report a successful outcome, the mean duration of pain relief was 2.87 months in the ICN group and 4.74 months in the DRG group (P = 0.01). CONCLUSIONS: Pulsed RF of the DRG was a superior treatment to pharmacotherapy and pulsed RF of the ICN in patients with CPTP. Prospective studies are needed to confirm these results and identify the best candidates for this treatment.

Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in Operation Iraqi Freedom: an epidemiological study conducted at two military pain management centers.

UNLABELLED: In recent military conflicts the major source of soldier attrition has not been battle injuries but more mundane causes similar to those encountered in civilian life. In an effort to determine the pain conditions affecting soldiers during wartime, we conducted an observational study among 162 soldiers medically evacuated from Operation Iraqi Freedom who were referred to 2 large pain treatment centers located outside the theaters of combat. Fifty-three percent of soldiers presented with either radicular (n = 49) or axial (n = 37) low back pain, with lumbar herniated disk being the most frequently diagnosed condition (24%). The two most implicated etiologies were exacerbation of a previous pain condition treated with surgery (15%) and motor vehicle accidents(12%). Only 17% of patients were injured during battle. Seventy-two percent of soldiers received at least one nerve block/injection, the most common of which was lumbar epidural steroid administration (22%). Nonsteroidal antiinflammatory drugs were prescribed to 56% of patients, opioids to 49%, and some form of alternative therapy to 17%. Among the 49 patients in whom data were available, only 2% returned to combat duty in Iraq. With the exception of battle-related injuries, the pain conditions suffered during modern warfare seem to be similar to those encountered in civilian pain clinics. To improve the return-to-duty rate, better preventive measures and more aggressive treatment conducted in forward-deployed medical units are recommended. IMPLICATIONS: We conducted an observational study at two large military pain treatment centers among soldiers injured in Operation Iraqi Freedom. Fifty-three percent of soldiers presented with low back pain, with lumbar herniated disk being the most common diagnosis. Only 2% of patients returned to combat duty in Iraq. To improve the return-to-duty rate, better preventive measures and more aggressive treatment in forward-deployed medical units are recommended.

Lumbar discography: a comprehensive review of outcome studies, diagnostic accuracy, and principles.

BACKGROUND AND OBJECTIVES: Since its advent more than 50 years ago, the use of discography has been mired in controversy. The purpose of this review is to provide a clinical overview of lumbar discography and discogenic back pain, with special emphasis on determining the accuracy of discography and whether or not the procedure improves outcomes for surgery. METHODS: Material for this review was obtained from a MEDLINE search conducted from 1951 thru September 2004, bibliographic references, book chapters, and conference proceedings. RESULTS: Based on a large number of comparative studies, plain discography is less accurate than magnetic resonance imaging in diagnosing lumbar herniated nucleus pulposus and comparable or slightly more sensitive in detecting degenerative disc disease. For disc degeneration, CT discography remains the gold standard for diagnosis. There are very few studies comparing surgical outcomes between patients who have undergone preoperative provocative discography and those who have not. What little evidence exists is conflicting. Before disc replacement surgery, approximately half the studies have used preoperative discography. A comparison of outcomes did not reveal any significant difference between the 2 groups but none of the studies was controlled, and they used different outcome measures, follow-up periods, and surgical techniques. Because all intradiscal electrothermal therapy (IDET) studies have used discography before surgery, no conclusions can be drawn regarding its effects on outcome. CONCLUSIONS: Although discography, especially combined with CT scanning, may be more accurate than other radiologic studies in detecting degenerative disc disease, its ability to improve surgical outcomes has yet to be proven. In the United States and Europe, there are inconsistencies in the use of lumbar discography such that it is routinely used before IDET, yet only occasionally used before spinal fusion.

Nucleoplasty with or without intradiscal electrothermal therapy (IDET) as a treatment for lumbar herniated disc.

BACKGROUND AND OBJECTIVE: In industrialized societies, the prevalence of radicular low back pain has exploded in recent years. The growing economic and personal costs of this challenging entity have led to the development of a wide array of new treatments, ranging from pharmacotherapy with neuropathic medications to open surgical treatment. Among the therapeutic options to emerge are a plethora of minimally invasive treatments aimed at removing nuclear material and lowering intradiscal pressure through devices inserted percutaneously into intervertebral discs. Yet there is a compelling lack of clinical evidence to support the use of these procedures. This study was undertaken to determine the treatment outcomes of 16 consecutive patients with lumbar radicular pain secondary to a herniated disc who underwent nucleoplasty as their primary therapy. METHODS: Included in this series were nine patients with significant axial back pain, sitting intolerance, and positive discography who also underwent intradiscal electrothermal therapy (IDET). Among the 7 patients who only had nucleoplasty, 4 had 2 discs treated and 3 had 1 disc. In the 9 patients who also had IDET, 6 had 1 disc treated and 3 had 2 discs treated. Of the 32 total disc treatments, 20 were at L5-S1, 10 were at L4-5 and 2, one each for IDET and nucleoplasty, were at L3-4. RESULTS: In the overall cohort, the average Visual Analogue Scale (VAS) pain score decreased from 6.7 to 5.6 at a mean follow-up of 9 months. In the seven patients who underwent only nucleoplasty, the mean VAS score decreased from 6.0 to 4.8. Only one patient reported a >/=50% reduction in pain score. CONCLUSIONS: We conclude that with use of the present selection criteria, nucleoplasty is not an effective long-term treatment for lumbar radiculopathy, either alone or with IDET. Before conducting future clinical trials, we recommend modifying these criteria to include only those patients with small (<6-mm) contained disc herniations whose annular integrity is documented by computed tomography discography and corresponding radicular symptoms confirmed by either selective nerve root blocks or electromyography and nerve conduction studies.

The causes of false-positive medial branch (facet joint) blocks in soldiers and retirees.

OBJECTIVE: The purpose of this study was to determine the factors associated with false-positive medial branch blocks (MBB), the nerve blocks used to diagnose facet arthropathy, in soldiers and retirees. METHODS: The study subjects were 78 patients with chronic low back pain who underwent diagnostic MBB to determine whether or not the facet joints were pain generators. Radiofrequency denervation of these nerves was performed in all patients with positive responses. Patients who failed to obtain pain relief after the blocks (negative blocks) and those who obtained temporary pain relief after MBB but failed radiofrequency denervation (false-positive blocks) then proceeded to undergo discography. Based on patients' responses to diagnostic blocks, discography results, the presence of radicular pain, and previous back surgery, the data were analyzed to determine whether any of these variables correlated with false-positive MBB. RESULTS: The presence of discogenic or radicular pain was not associated with a higher false-positive response rate to MBB. Conversely, the absence of discogenic pain was associated with a higher percentage of false-positive blocks. There was also a trend for patients with previous back surgery to have a higher false-positive rate than those who had not undergone previous surgery. CONCLUSIONS: Although a high incidence of epidural and foraminal spread occurs during the performance of MBB, this is unlikely to be a significant cause of false-positive blocks.

A novel technique for delivery of epidural steroids and diagnosing the level of nerve root pathology.

Transforaminal epidural steroids are a commonly used technique for diagnosis and treatment of nerve root irritation secondary to herniated disc material. The recent reported occurrences of severe complications using the transforaminal technique have led to the search for a novel alternative that is both a safe and accurate method of steroid delivery. The technique described offers improved safety and diagnostic accuracy over traditional transforaminal steroid injections.